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Turner, Dan. "Particularities of IBD Trials in Children." Current Pharmaceutical Design 25, no. 1 (May 23, 2019): 69–72. http://dx.doi.org/10.2174/1381612825666190307125511.
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Pediatric inflammatory bowel diseases (IBD) are similar to the adult-onset type in many aspects, including the necessity of high-quality randomized controlled trials. However, recruiting children into clinical trials is conceptually more challenging than in adults. Furthermore, the long delay between adult and pediatric approval of new drugs leads not only to the unbearable extensive use of these drugs as off-label without appropriate dosing and safety data but also to more challenges when eventually the pediatric trial is performed. This review offers possible solutions to age-specific pitfalls in performing trials in pediatric IBD. Many of the challenges could be adequately addressed by accepting full extrapolation of efficacy from adult trials. This is advisable if small pharmacokinetics/ pharmacodynamics (PK/PD) studies show similarity to adult data. Then, pediatric trials can focus on dosing and safety while avoiding the controversial use of placebo. Judicious use of non-invasive activity scores and biomarkers, providing immediate and effective treatment in active disease and ensuring equipoise of treatments both within and outside the trial are the mainstay of a feasible trial in children. The recent trend of including adolescents in adult phase-3 trials addresses some obstacles but introduces others. Acknowledging and addressing these age-specific challenges would facilitate pediatric drug development in IBD.
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Theilacker, Christian, Mark A. Fletcher, Luis Jodar, and Bradford D. Gessner. "PCV13 Vaccination of Adults against Pneumococcal Disease: What We Have Learned from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA)." Microorganisms 10, no. 1 (January 8, 2022): 127. http://dx.doi.org/10.3390/microorganisms10010127.
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The Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA) evaluated older adult pneumococcal vaccination and was one of the largest vaccine clinical trials ever conducted. Among older adults aged ≥65 years, the trial established 13-valent pneumococcal conjugate vaccine (PCV13) efficacy in preventing first episodes of bacteremic and nonbacteremic pneumococcal vaccine serotype (VT) community acquired pneumonia (CAP), and of vaccine serotype invasive pneumococcal disease (VT-IPD). Since the publication of the original trial results, 15 additional publications have extended the analyses. In this review, we summarize and integrate the full body of evidence generated by these studies, contextualize the results in light of their public health relevance, and discuss their implications for the assessment of current and future adult pneumococcal vaccination. This accumulating evidence has helped to better understand PCV13 efficacy, serotype-specific efficacy, efficacy in subgroups, the interpretation of immunogenicity data, and the public health value of adult PCV vaccination.
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Reynolds, O. L., and B. A. Orchard. "Effect of adult chill treatments on recovery, longevity and flight ability of Queensland fruit fly, Bactrocera tryoni (Froggatt) (Diptera: Tephritidae)." Bulletin of Entomological Research 101, no. 1 (July 8, 2010): 63–71. http://dx.doi.org/10.1017/s0007485310000210.
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AbstractControl of Queensland fruit fly, Bactrocera tryoni (Froggatt) (Diptera: Tephritidae), populations or outbreaks may be achieved through the mass-rearing and inundative release of sterile B. tryoni. An alternative release method is to release chilled adult sterile fruit flies to decrease packaging and transport requirements and potentially improve release efficiencies. Two trials were conducted to determine the effect of chilling on the performance of two separate batches of adult B. tryoni, fed either a protein and sucrose diet or sucrose only diet. The first trial compared chill times of 0, 0.5, 2 and 4 h; the second trial compared chill times of 0, 2, 4, 8 and 24 h. Overall, there was little or no affect of chilling on the recovery, longevity and flight ability of B. tryoni chilled at 4°C. Recovery time can take up to 15 min for chilled adult flies. There was no effect of chill time on longevity although females generally had greater longevity on either diet compared with males. Propensity for flight was not adversely affected by chilling at the lower chill times in trial 1; however, in trial 2, adults fed on a protein and sucrose diet had a decreased tendency for flight as the chilling time increased. Fly body size did not affect recovery times although the smaller adult B. tryoni in trial 1 had significantly reduced longevity compared to the larger adults in trial 2. Implications of these findings for B. tryoni SIT are discussed.
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Mottl, Alexis A., Susan G. Fisher, Richard I. Fisher, Louis S. Constine, and Jonathan W. Friedberg. "Adolescents with Hodgkin Lymphoma Treated on Adult and Pediatric Protocols Have Distinct Therapeutic Outcome." Blood 104, no. 11 (November 16, 2004): 312. http://dx.doi.org/10.1182/blood.v104.11.312.312.
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Abstract Hodgkin Lymphoma (HL) is a B cell malignancy, highly curable in the modern era (1989–2004). It is the most common cancer in the 15–19 age range. In the United States, adolescents with de novo HL may be treated on either pediatric or adult protocols. To identify outcomes of adolescents with HL, we conducted a comprehensive literature review and statistical analysis of all treatment trials (N > 50 pts) published in the past 15 years. Trials were selected for their relevance to treatment and disease outcome in adolescents with the following search criteria: Hodgkins disease, therapy, treatment, adolescents (13–18 years), and adults (19–44 years). The search retrieved 120 randomized control trials and 57 Phase II trials. 117 trials were eliminated due to inappropriate histology, non-clinical endpoints, topic reviews or otherwise not meeting established criteria. 79 studies were eligible for analysis. 15 pediatric treatment protocols (13 multi-center, 7 randomized) met established criteria. 7 identified the number of adolescents on trial (N=958/2675; 36%). Only 3 of these studies evaluated adolescent outcome; one trial demonstrated an inferior event-free survival for the adolescent subgroup vs. all children (72.0% vs. 89.0%; p-value 0.006, Chi Square Test). 57 adult treatment studies (39 multi-center, 44 randomized) were reviewed. 7 identified the number of adolescents on trial (N=422/2522; 17%). Only one provided information on adolescent outcome, which experienced a superior overall survival compared with the entire population (86.0% vs. 73.1%; p-value 0.030, Chi Square Test). None of the trials with both pediatric and adult subjects (7 multi-center, 4 randomized) provided information on the adolescent subgroup. In comparing pediatric and adult trials, we found remarkable differences in therapeutic approaches (all pediatric studies included XRT as a treatment component compared to 58% of adult studies) and in trial design (77% of adult studies were randomized compared to 47% of pediatric studies; p-value 0.0234, Fishers Exact Test). The adolescent population with HL is significantly understudied despite reasonable clinical trial participation and relatively high prevalence. In fact, only 4 published trials provided outcome information on adolescents with HL; in 2, outcome was statistically different from the rest of the study population, suggesting this subgroup may benefit from a specialized treatment approach. It is critical for future treatment trials to analyze results of the adolescent population to determine whether unique biological features, therapeutic practices, or host factors contribute to prognosis and outcome.
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Mahajan, Anita, Helen Shih, Marta Penas-Prado, Keith Ligon, Kenneth Aldape, Leland S. Hu, Ashlee R. Loughan, et al. "The Alliance AMBUSH Trial: Rationale and Design." Cancers 14, no. 2 (January 14, 2022): 414. http://dx.doi.org/10.3390/cancers14020414.
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Unlike medulloblastoma (MB) in children, robust prospective trials have not taken place for older patients due to the low incidence of MB in adults and adolescent and young adults (AYA). Current MB treatment paradigms for older patients have been extrapolated from the pediatric experience even though questions exist about the applicability of these approaches. Clinical and molecular classification of MB now provides better prognostication and is being incorporated in pediatric therapeutic trials. It has been established that genomic alterations leading to activation of the sonic hedgehog (SHH) pathway occur in approximately 60% of MB in patients over the age of 16 years. Within this cohort, protein patched homolog (PTCH) and smoothened (SMO) mutations are commonly found. Among patients whose tumors harbor the SHH molecular signature, it is estimated that over 80% of patients could respond to SHH pathway inhibitors. Given the advances in the understanding of molecular subgroups and the lack of robust clinical data for adult/AYA MB, the Alliance for Clinical Trial in Oncology group developed the AMBUSH trial: Comprehensive Management of AYA and Adult Patients with Medulloblastoma or Pineal Embryonal Tumors with a Randomized Placebo Controlled Phase II Focusing on Sonic Hedgehog Pathway Inhibition in SHH Subgroup Patients (Adult & Adolescent MedulloBlastoma Using Sonic Hedgehog Trial). This trial will enroll patients 18 years of age or older with MB (any molecular subgroup and risk stratification) or pineal embryonal tumor. Patients will be assigned to one of three cohorts: (1) average risk non-SHH-MB, (2) average risk SHH-MB, and (3) high risk MB or pineal embryonal tumors. All patients will receive protocol-directed comprehensive treatment with radiation therapy and chemotherapy. Patients with SHH-MB in cohort 1 will be randomized to a smoothened inhibitor or placebo as maintenance therapy for one year.
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Neel, Dylan, David Stephen Shulman, and Steven G. DuBois. "Sponsorship of pediatric oncology interventional trials." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 10044. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.10044.
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10044 Background: The sponsor of a clinical trial is the single entity responsible for the overall conduct and oversight of the trial. Sponsors may be pharmaceutical/biotech companies (“industry”), government agencies (e.g. NIH), or other entities such as academic institutions. Trial sponsorship may have important regulatory and financial implications for the trial intervention under investigation. We sought to compare oncology trial sponsorship based upon age of eligibility. Methods: We used the clinicaltrials.gov database to evaluate all interventional trials from September 1, 2009 to December 1, 2018. We included all trials regardless of indication and then separately analyzed only oncology trials. We analyzed sponsor status as “industry”, “government”, or “other”. Results: Sponsorship data were available for 59,582 interventional trials across all disciplines (n = 15,564 oncology trials). Across all disciplines and ages of eligibility, lead trial sponsorship was 34% industry, 5% government, and 61% other. Across all oncology trials, sponsorship mix was similar: 31% industry; 6% government, and 62% other. Among adult oncology trials (age of eligibility starting at age 18 years), trial sponsorship was 33% industry, 6% government, and 61% other. Among pediatric-only oncology trials (age of eligibility capped < 18 years), trial sponsorship was 25% industry, 1% government, and 74% other. 5% of industry sponsored trials across all indications were pediatric-only compared to 0.63% of industry-sponsored trials in oncology. 95% of industry sponsored pediatric-only oncology trials were phase 1 or 2 trials, compared to 90% in adults. Conclusions: Pediatric-only interventional oncology trials are less likely to be industry sponsored compared to adult oncology trials or trials across all disciplines. Less than 1% of industry sponsored interventional trials in oncology focus on children < 18 years of age.
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FUNAKI, Takeshi, Jun C. TAKAHASHI, Susumu MIYAMOTO, and JAM Trial Group. "Japan Adult Moyamoya Trial: Results and Future Directions." Surgery for Cerebral Stroke 44, no. 4 (2016): 272–75. http://dx.doi.org/10.2335/scs.44.272.
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Combest, Austin James, Dirk J. Reitsma, Angelena Moseley, Savanna D. Steele, and Marie-Edith Anne Bonneterre. "Adult participation in oncology clinical trials by indication, race, and age." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e17586-e17586. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e17586.
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e17586 Background: According to the National Cancer Institute (NCI), approximately 3 percent of adult cancer patients participate in clinical trials despite the NCCN guidelines frequently recommending clinical trials as standard of care in many circumstances (Mooney, 2010). In a large analysis of NCI Cancer Therapy Evaluation Program (CTEP) trials, 40 percent of trials failed to achieve minimum enrollment, including 3 of 5 phase III trials (Cheng, 2010). Additionally, concerns about unequal access to clinical trials led Congress to enact the National Institutes of Health (NIH) Revitalization Act 20 years ago (June 10, 1993). Using data from Ipsos’ Tandem Oncology Monitor, a robust, nationwide system that collects actual prescriptions and clinical trial participation by indication from 500 oncologists and hematologists from the United States, we evaluated current participation and ethnic diversity in clinical trials. Methods: We assessed adult clinical trial participation from October 2011 to September 2012. Age, ethnicity and practice type were also collected to identify descriptive trends. Results: With regards to indication, clinical trial participation ranged from 1 percent (prostate, renal cell and head and neck) to 12 percent (thyroid) averaging between 2 and 3 percent. We observed a decline in first-line metastatic melanoma participation between pre- and post- vemurafenib/ipilimumab approval (9%-pre versus 2%-post). Patient diversity results are included in the Table. Conclusions: Despite efforts to increase oncology clinical trial participation, we have observed overall low clinical trial participation. Additionally, we observed better trial participation in the youngest age groups and minor differences between ethnic categories. Continued focus on increasing trial participation and patient diversity is still needed. [Table: see text]
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Keegan, Theresa H. M., and Helen M. Parsons. "Adolescent angst: enrollment on clinical trials." Hematology 2018, no. 1 (November 30, 2018): 154–60. http://dx.doi.org/10.1182/asheducation-2018.1.154.
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Abstract Survival among adolescents and young adults (AYAs) ages 15 to 39 with cancer has not improved to the same extent as that of pediatric and older adult cancer patients, which is thought to relate, in part, to the lower participation of AYAs in clinical trials. Because significant efforts have been made to improve clinical trial enrollment for AYAs, we (1) present contemporary clinical trial enrollment rates by cancer type, sociodemographic characteristics, and treatment setting and (2) discuss provider-, patient-, and system-level barriers to clinical trial participation. Contemporary studies examining clinical trial enrollment among AYAs have continued to find low overall participation relative to pediatric populations, with most studies observing no significant improvements in enrollment over time. In addition to age and cancer type, enrollment varies by treatment setting, health insurance, and race/ethnicity. Access to available clinical trials may be increased by appropriate referral of AYAs to pediatric and adult specialty cancer centers with studies relevant to the AYA population because most AYAs are treated in the community setting. Even with similar access to trials, however, AYAs may be less likely to participate, and therefore, future efforts should focus on better understanding and addressing barriers to enrollment as well as improving education and outreach regarding clinical trials.
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Tjernström, Fredrik, Jennie Oredsson, and Måns Magnusson. "A "wait and learn" strategy of postural control learning in children?" Journal of Vestibular Research 16, no. 6 (July 1, 2007): 257–64. http://dx.doi.org/10.3233/ves-2006-16602.
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This study compares the children and adult response to a novel postural challenge. One group of children (n=13, age 7–9) and one adult reference group (n=12 age 15–32) were subjected to vibration induced body sway and posturography with both open and closed eyes for 5 consecutive days. There was a gradual decrease of induced body sway over time in both groups (p< 0.001) between the subsequent trials, but only in the adult group was there a reduction of induced body sway over time within each trial (p< 0.05). The children had on a considerably less level of induced body sway when they started the second trial than they finished the first (p< 0.01). There appears to be a different approach of adaptation to a new postural challenge between children and adults.
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Ivy, Dunbar. "The Pediatric Sildenafil Trial." Advances in Pulmonary Hypertension 10, no. 4 (December 1, 2012): 215–16. http://dx.doi.org/10.21693/1933-088x-10.4.215.
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While we have long understood pulmonary arterial hypertension (PAH) to be a chronic disorder of the pulmonary vasculature that can lead to right heart failure and death if untreated, there are currently no therapies approved for children. Recommendations for treatment for children have been derived from evidence-based adult guidelines. However, limited data suggest benefits for children utilizing drugs approved for adults. This landmark study is the first randomized, double-blind, placebo-controlled trial of a PAH therapy in children.
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Crawley, Melissa Ann, Matthew K. Stein, Kruti Patel, and Michael G. Martin. "Clinical Trial Availability in Adolescent and Young Adult Patients with Non-Hodgkin Lymphoma." Blood 128, no. 22 (December 2, 2016): 5937. http://dx.doi.org/10.1182/blood.v128.22.5937.5937.
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Abstract Introduction Incidence of non-Hodgkin lymphoma (NHL) in adolescent and young adults (AYAs) has increased over the last 25 years. Diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, anaplastic large cell lymphoma, lymphoblastic lymphoma, and primary mediastinal B-cell lymphoma are the most common subtypes in patients between the ages of 15 and 19; follicular lymphoma has increased incidence in AYAs who are at least 20 years old.1 Additionally, AYAs with non-Hodgkin lymphoma have increased relapse rates and increased mortality compared to both their childhood and adult counterparts.2 Clinical trials of novel agents often exclude subjects under the age of 18. Because of this, we hypothesized that treatment in adult centers may be associated with increased availability of clinical trials studying novel agents in these at-risk patients. Methods A keyword search of "Non-Hodgkin Lymphoma" in the database maintained by ClinicalTrials.govwas performed on May 1, 2016. Age groups, sample size, information on the studied agents, and lymphoma subtypes were collected, as well as whether study sites were members of the Children's Oncology Group. Seventeen categories of novel agents were identified; data was collected on any novel agent contained within a trial protocol. Results Of the 726 trials in the initial data set, 404 trials were included in our analysis; studies were excluded from the analysis if the study regimen did not contain a novel pharmacologic agent, or if they focused solely on a transplant conditioning regimen. Sixty-one studies (15%) of novel agents were open to enrollment for subjects under the age of 18 (Table 1). Twenty-five (25) of these trials of these utilized cellular therapy (CAR-T cells, donor lymphocytes, and cytotoxic T lymphocytes). Trials of tyrosine kinase inhibitors (7), novel small molecules (7), monoclonal antibodies (5) were the next-most common agents utilized in clinical trials with the remaining agent classes further detailed in Table 2. Of the 343 trials that were limited to patients who were at least 18 years old, 227 (66%) trials allowed the enrollment of subjects with DLBCL, Burkitt lymphoma, anaplastic large cell lymphoma, lymphoblastic lymphoma, follicular lymphoma, and primary mediastinal B cell lymphoma. All agent classes were represented in trials open to patients who were at least 18 years old; however, three agent classes were excluded from clinical trials in the under-18 subset: BiTE immunotherapy, PI3K inhibitors, and pleiomorphic pathway modifiers. Additionally, 178 of 343 trials (51%) included in the analysis that excluded patients under 18 years old had at least one study site which was a member of the Children's Oncology Group. Conclusions Adolescent and young adult patients with non-Hodgkin lymphoma have higher relapse rates and lower survival rates than both their pediatric and older adult counterparts. The vast majority of trials study novel agents in the NHL subtypes that most commonly affect the adolescent and young adult population. Half of the trials that exclude patients under 18 years old take place at Children's Oncology Group member sites. While this suggests that adolescent and young adult patients treated at Children's Oncology Group member sites may have access to trials studying novel agents, the extent to which AYAs are being enrolled in these trials requires further study. [1]Hochberg, J., Waxman, I.M., Kelly, K.M., Morris, E. & Cairo, M.S. (2009) Adolescent NHL and Hodgkin lymphoma: state of the science. Br J Haematol, 144, 24-40. [2] Bleyer A, O'Leary M, Barr R, Ries LAG (eds): Cancer Epidemiology in Older Adolescents and Young Adults 15 to 29 Years of Age, Including SEER Incidence and Survival: 1975-2000. National Cancer Institute, NIH Pub. No. 06-5767. Bethesda, MD 2006. Table 1 Age Groups in Clinical Trials for Non-Hodgkin Lymphoma. Table 1. Age Groups in Clinical Trials for Non-Hodgkin Lymphoma. Table 2 Clinical trial enrollment and COG availability by agent class Table 2. Clinical trial enrollment and COG availability by agent class Disclosures No relevant conflicts of interest to declare.
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Le-Rademacher, Jennifer, Supriya Mohile, Joseph Unger, Matthew F. Hudson, Jared Foster, Stuart Lichtman, Jane Perlmutter, et al. "Trial Design Considerations to Increase Older Adult Accrual to National Cancer Institute Clinical Trials." JNCI Monographs 2022, no. 60 (December 1, 2022): 135–41. http://dx.doi.org/10.1093/jncimonographs/lgac023.
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Abstract Although adults aged 65 years or older make up a strong majority of cancer patients, their underrepresentation in cancer clinical trials leads to the lack of representative data to guide evidence-based therapeutic decisions in this patient population. The Trial Design Working Group, convened as part of the workshop titled, Engaging Older Adults in the National Cancer Institute Clinical Trials Network: Challenges and Opportunities, recommended study designs and design elements that could improve accrual of older adults in National Cancer Institute–funded clinical trials. These include trials that are specifically designed to enroll older adults, trials that include a cohort of older patients (parallel cohort, stratified cohort, or embedded cohort), and trials with pragmatic design elements to facilitate enrollment of older adults. This manuscript provides brief descriptions of the recommended designs, examples of successful trials, and considerations for implementation of these designs. As with any clinical trial, the scientific questions and trial objectives should drive the study design, the selection of endpoints and intervention, and eligibility criteria. When designing trials that include older adults, the heterogeneity of fitness levels is an important consideration as fitness can influence accrual rates and outcomes. Appropriately incorporating geriatric assessments can help identify the optimal subset of older patients for inclusion and minimize selection bias. Incorporating pragmatic design elements to reduce the burden on trial participants as well as on accruing sites and retaining essential elements to ensure that the main goal of the trial can be accomplished can enhance enrollment without compromising the integrity of trials.
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Keller, J. K., J. Bowman, J. A. Lee, M. A. Mathiason, K. A. Frisby, C. M. Meyer, L. A. Meyer, L. J. Wright, and R. S. Go. "Cancer clinical trials available in the community setting: A 5-year analysis from 1999–2004." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 6056. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.6056.
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6056 Background: Less than 5% of newly diagnosed cancer patients are accrued into clinical trials. In the community setting, the lack of appropriate clinical trials is a major barrier. Our prospective study in 2004 determined that 58% of newly diagnosed adult cancer patients at our community-based cancer center didn’t have a clinical trial available appropriate for their disease stage. Among those with clinical trials, 23% were subsequently found to be ineligible (Go RS, et al. Cancer 2006, in press). However, the availability of clinical trials may vary from year to year. Methods: A retrospective study was conducted to determine what clinical trials were available for newly diagnosed adult cancer patients at our institution from June 1999-July 2004. The study also investigated the proportions of newly diagnosed patients who had a clinical trial available appropriate for type and stage of disease and patients accrued. Results: Over the 5-year period, 207 (82, 87, 99, 102, 117, years 1–5, respectively) trials were available. Most (50.7%) trials were for the following cancers: breast (15.5%), lung (13.5%), head and neck (7.7%), colorectal (7.2%) and lymphoma (6.8%). ECOG (53%), RTOG (26%), and CTSU (9%) provided the majority of the trials. A total of 5,776 new adult cancer patients were seen during this period. Overall, 60% of the patients had a trial available appropriate for type and stage of their cancer, but only 103 (3%) were enrolled. There was a significant upward trend in the proportions of patients with available trials over the years (60.2%, 55.9%, 59.2%, 60.7%, 63.9%, years 1–5, respectively; Mantel-Haenszel P=.008). The proportion of patients with a trial available was highest for prostate (97.3%), lung (90.9%), and breast (73.9%), and lowest for melanoma (17.1%), renal (11.6%), and bladder (7.2%). The majority of patients accrued to trials had the following cancers: breast (32%), lung (17%), lymphoma (9%), colon (7%), and prostate (5%). Conclusions: Nearly half of the newly diagnosed adult patients at our center had no trials available appropriate for type and stage of their cancers. It is likely that if strict clinical trial eligibility criteria were applied, approximately 2/3 of our patients would not be eligible for a clinical trial. No significant financial relationships to disclose.
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Lee, W., A. Basu, JJ Carlson, and D. Veenstra. "SA12 Can We Predicting Trial Failure Among Older Adult-Specific Clinical Trials Using Trial-Level Factors?" Value in Health 25, no. 7 (July 2022): S606. http://dx.doi.org/10.1016/j.jval.2022.04.1678.
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Flerlage, Jamie E., Monika L. Metzger, and Nickhill Bhakta. "The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice?" Blood 132, no. 4 (July 26, 2018): 376–84. http://dx.doi.org/10.1182/blood-2018-01-778548.
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Abstract Adolescents and young adults (AYAs) comprise the largest age group affected by Hodgkin lymphoma (HL). Despite excellent overall survival of AYA patients with HL due to advances in treatment regimens, therapy-associated late effects continue to be a concern in HL survivors, especially for younger patients who have decades of life remaining. Since the first clinical trial for HL with chemotherapy in 1964, subsequent protocols have attempted to reduce chemotherapy-induced toxicities and yet maintain high overall survival rates. Today, new analytic methods applied to data from survivorship cohorts, such as the recently described cumulative burden of disease metric, can be used to inform changes for future protocols. Although pediatric and adult trial consortia have followed this process, the AYA population, an age cohort split between pediatric and adult health care services, faces many barriers to care and is the least likely to be enrolled in clinical trials. AYA patients with HL theoretically have a choice to be treated in pediatric or adult protocols when presented with these options. Recent efforts by the National Clinical Trials Network, the Children’s Oncology Group, and others have been made to ensure that the burden of choice for the AYA population is not greater than the burden of disease.
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Petit, Caroline, Adeline Samson, Satoshi Morita, Moreno Ursino, Jérémie Guedj, Vincent Jullien, Emmanuelle Comets, and Sarah Zohar. "Unified approach for extrapolation and bridging of adult information in early-phase dose-finding paediatric studies." Statistical Methods in Medical Research 27, no. 6 (October 5, 2016): 1860–77. http://dx.doi.org/10.1177/0962280216671348.
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The number of trials conducted and the number of patients per trial are typically small in paediatric clinical studies. This is due to ethical constraints and the complexity of the medical process for treating children. While incorporating prior knowledge from adults may be extremely valuable, this must be done carefully. In this paper, we propose a unified method for designing and analysing dose-finding trials in paediatrics, while bridging information from adults. The dose-range is calculated under three extrapolation options, linear, allometry and maturation adjustment, using adult pharmacokinetic data. To do this, it is assumed that target exposures are the same in both populations. The working model and prior distribution parameters of the dose–toxicity and dose–efficacy relationships are obtained using early-phase adult toxicity and efficacy data at several dose levels. Priors are integrated into the dose-finding process through Bayesian model selection or adaptive priors. This calibrates the model to adjust for misspecification, if the adult and pediatric data are very different. We performed a simulation study which indicates that incorporating prior adult information in this way may improve dose selection in children.
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Reding, Michael E. "Black Vine Weevil (Coleoptera: Curculionidae) Performance in Container- and Field-Grown Hosts." Journal of Entomological Science 43, no. 3 (July 1, 2008): 300–310. http://dx.doi.org/10.18474/0749-8004-43.3.300.
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The black vine weevil (Otiorhynchus sulcatus F.) feeds on a variety of plant species and is a serious pest of ornamental nursery crops. The larval stage has a more restricted diet than the adult stage, but the larvae are more damaging because they feed on roots and often stunt or kill their hosts. Performance and establishment of larvae in various container- and field-grown nursery crops were examined. In trials on containerized plants, adult black vine weevil were caged with various combinations of known larval hosts. In these trials, most larvae were found in Sedum and Heuchera versus Astilbe, redbud, and Taxus. Larvae collected from Sedum weighed significantly more than those from Heuchera or Taxus. In one field trial, adult black vine weevils were released, and establishment of larvae among potential hosts was examined. In this trial, Sedum was a better host than hemlock or Rudbeckia. Based on the numbers of larvae found in the different plant species, Sedum was the best host for larvae. Another field trial examined the influence of mulch on the occurrence of larvae. The presence of mulch around small field-grown Taxus plants did not increase the numbers of larvae compared with bare soil. The presence of aged pine bark or Taxus needle mulches did not influence the occurrence of black vine weevils in field plots of young Taxus. Data from monitoring adults suggest they either emigrated from these plots within several weeks of emergence, although suitable hosts were present, or there was high mortality.
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JAM Trial Group. "Japan Adult Moyamoya (JAM) Trial in 2002." Surgery for Cerebral Stroke 31, no. 1 (2003): 13–17. http://dx.doi.org/10.2335/scs.31.13.
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La Rosée, Paul. "First prospective clinical trial in adult HLH." Blood 126, no. 19 (November 5, 2015): 2169–71. http://dx.doi.org/10.1182/blood-2015-09-666503.
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JAM, Trial Group. "Japan adult moyamoya (JAM) trial in 2002." Nosotchu 24, no. 4 (2002): 480–84. http://dx.doi.org/10.3995/jstroke.24.480.
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SCHETKY, DIANE H. "Juveniles Standing Trial: Waiver to Adult Court." Journal of Psychiatric Practice 9, no. 6 (November 2003): 465–68. http://dx.doi.org/10.1097/00131746-200311000-00010.
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Stark, Susy. "Can We Do Better for Older Adult Research Participants? Clinical Trial Improvements Prompted by a Global Pandemic." Innovation in Aging 5, Supplement_1 (December 1, 2021): 103–4. http://dx.doi.org/10.1093/geroni/igab046.394.
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Abstract Retaining older adults in clinical trials has often been a challenge for researchers. Clinical trial procedures, aimed at improving fidelity, often offer barriers to frail older adults who have challenges traveling to medical centers and enduring long clinical assessment visits. During the COVID-19 pandemic, we modified the procedures of two randomized controlled trials. COMPASS: A novel transition program to reduce disability after stroke is a clinical trial examining the efficacy of a transition home program that provides home modifications and self-management strategies compared to stroke education. HARP: Removing home hazards for older adults living in affordable housing is a pragmatic trial examining the effectiveness of a home hazard removal program for residents of low-income housing. Modifications to the trials were designed to reduce human contact but in some cases reduced the burden on trial participants. Modified procedures addressed retention, assessment of endpoints and intervention methods.
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Chalwin, R. P., J. L. Moran, and P. L. Graham. "The Role of Extra Corporeal Membrane Oxygenation for Treatment of the Adult Respiratory Distress Syndrome: Review and Quantitative Analysis." Anaesthesia and Intensive Care 36, no. 2 (March 2008): 152–61. http://dx.doi.org/10.1177/0310057x0803600203.
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The role of Extra corporeal membrane oxygenation (ECMO) has not been formally validated for patients with adult respiratory distress syndrome. In anticipation of publication of the conventional ventilation versus ECMO in severe adult respiratory failure (CESAR) trial, the role of ECMO in this setting was reviewed. An electronic search for studies reporting the use of ECMO for the treatment of adult respiratory distress syndrome revealed two randomised controlled trials and three non-controlled trials. Bayesian analysis on the two randomised controlled trials produced an odds ratio mortality of 1.28 (credible interval 0.24 to 6.55) demonstrating no significant harm or benefit. Pooling was not possible for the non-controlled studies because of differing admission status and ECMO selection criteria and an inability to control for these differences in the absence of individual patient data. A large number (n=35) of case series have been published with generally more positive results. We also present a comprehensive narrative commentary on the history, current practice and future for ECMO. ECMO, as rescue therapy for adult respiratory distress syndrome, appears to be an unvalidated rescue treatment option. Analysis and review of trial data does not support its application; however the body of reported cases suggests otherwise. Until the CESAR trial provides an authoritative answer ECMO will continue to be offered on a case by case basis.
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Miura, Hajime, Miduki Ishikawa, and Kenichi Deguchi. "Moderate-intensity Arm-cranking Exercise may not Improve Arterial Function in Healthy Adult Men." International Journal of Sports Medicine 39, no. 13 (September 18, 2018): 962–66. http://dx.doi.org/10.1055/a-0664-8823.
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AbstractEndurance exercises, such as cycling or running, are useful for improving arterial function. However, people suffering from partial paralysis or arthritis are unable to perform these kinds of lower-limb exercises. In the present study, we explored the acute effect of upper-arm exercise on arterial stiffness in healthy men. Fourteen healthy adult men performed two experimental trials. The order of experiments was randomized between a 30-min arm-cranking exercise at 50% V̇O2max (A-trial) and a 30-min leg-cycling exercise at 50% V̇O2max (C-trial). The brachial to ankle pulse wave velocity (baPWV), brachial systolic/diastolic blood pressure and heart rate were obtained with subjects in the supine position. The baseline hemodynamic values were not markedly different between the two trials. Compared with the baseline value, the baPWV was significantly reduced at 30 and 60 min after the C-trial. In the A-trial, however, there were no significant changes in the baPWV throughout the trial. These results indicate that acute 50% V̇O2max arm-cranking exercise induced relatively little change in the baPWV, which was the opposite of the finding observed with leg-cycling exercise. Therefore, in order to improve arterial function via aerobic upper-arm exercises, the exercise mode/intensity or other approaches should be considered.
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Unger, Joseph M., and Mark Fleury. "Nationally representative estimates of the participation of cancer patients in clinical research studies according to the commission on cancer." Journal of Clinical Oncology 39, no. 28_suppl (October 1, 2021): 74. http://dx.doi.org/10.1200/jco.2020.39.28_suppl.74.
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74 Background: The successful conduct of cancer clinical trials hinges on the willingness of patients to participate. The rate of adult clinical trial participation has been regarded as being < 5%. However, national estimates of trial participation are nearly two decades old, and no evidence based on original data sources has been examined for many years. Moreover, studies about trial participation have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other key elements of clinical research, such as quality of life or biorepository studies. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from 1,200 institutions. Methods: The data were from the Commission on Cancer (CoC), a consortium of cancer-related organizations providing accreditation for both academic and community cancer care facilities across the U.S. CoC enrollment data represent 70% of all cases of cancer diagnosed each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality of life, registry, and screening studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (e.g., NCI-designated cancer programs) and pooled. Results: Across the entire U.S. system, the estimated participation rate to cancer treatment trials was 6.3%. Enrollment to treatment trials was highest at NCI-designated comprehensive cancer centers (18.9%), while for community cancer programs (CCPs) and comprehensive CCPs, treatment trial rates were 4.4% and 3.6%, respectively. Nearly 1 in 7 patients participated in biorepository studies (13.4%), including 39.4% at NCI cancer centers. Patients participated in a wide variety of other study types, including registry (8.1%), prevention (6.4%), genetic (3.6%), quality of life (2.9%), economic (2.7%), diagnostic (2.7%), and screening studies (1.8%). At least 25.4% of adult cancer patients were estimated to participate in one or more cancer clinical research studies. Conclusions: In a first-time use of nationally representative enrollment data from the CoC, enrollment to cancer treatment trials was 6.3%, higher than historical estimates of < 5%. Patients participated in a diverse set of other study types, and taken together, at least one quarter of patients participated in a study. Contributions of adult patients with cancer to clinical research is much more comprehensive than previously understood.
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Rao, Pooja, Yimei Li, Todd A. Alonzo, Lillian Sung, Robert B. Gerbing, Kelly D. Getz, Alix E. Seif, et al. "Patient Factors Associated with Enrollment on an Acute Myeloid Leukemia Phase III Clinical Trial: A Report from the Children’s Oncology Group." Blood 124, no. 21 (December 6, 2014): 2286. http://dx.doi.org/10.1182/blood.v124.21.2286.2286.
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Abstract The increased survival of children with cancer is largely credited to treatment on clinical trials. As such there is interest in determining factors associated with trial enrollment. Adult oncology studies suggest non-Whites are less likely to enroll than Whites on clinical trials. Additional factors, such as insurance and geographic region, have been associated with adolescent and adult trial enrollment. Data describing factors associated with pediatric trial enrollment is limited. This study sought to evaluate whether race and other patient factors were associated with enrollment on the recently completed Children's Oncology Group (COG) acute myeloid leukemia (AML) chemotherapy trial AAML0531. A retrospective cohort study was conducted using data from the Pediatric Health Information System (PHIS) and trial data from COG AAML0531. PHIS is an administrative database containing inpatient data from Child Health Corporation of America-affiliated hospitals. Data from a previously assembled and validated PHIS AML cohort was merged with data from the AAML0531 trial for the period of time that the COG trial was open and PHIS data was available (2006 to 2010). Patients that were identified in both the PHIS and COG datasets were labeled as enrolled patients and those only in the PHIS database were labeled as not enrolled patients. Enrolled and not enrolled patients were compared by race, gender, age, insurance type, illness severity at AML presentation (defined by need for an ICU intervention in the first or second day of index admission) and geographic region of hospitalization. Chi-square test and logistic regression analyses were used for unadjusted and adjusted comparisons, respectively. The PHIS AML cohort contained 874 patients of which 312 (36%) were enrolled on AAML0531. Table 1 displays the comparison of enrolled versus not enrolled patients by each of the demographic and clinical variables of interest. In adjusted analyses patients were less likely to enroll if they had government insurance (compared to private insurance). Patients were more likely to enroll if they were hospitalized in the West (compared to the South). Trial enrollment percentage was higher than reported in adult cooperative group trials but still comprised a minority of potentially eligible patients. Unlike adult clinical trials, race was not associated with enrollment on the AAML0531 trial. However, patients who did enroll on AAML0531 were less likely to have government insurance and more likely to be hospitalized in the West. Work is ongoing to refine estimates of enrollment eligible patients, to define patient socio-economic status more precisely than insurance status, and to evaluate the impact of insurance status beyond socio-economic status. Such analyses should provide additional data to guide efforts to increase trial enrollment and ensure equitable access to COG AML clinical trials for all pediatric patients. Disclosures No relevant conflicts of interest to declare.
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Ben Abdelali, Raouf, Vahid Asnafi, Thibaut Leguay, Nicolas Boissel, Agnès Buzyn, Patrice Chevallier, Xavier Thomas, et al. "Pediatric-inspired intensified therapy of adult T-ALL reveals the favorable outcome of NOTCH1/FBXW7 mutations, but not of low ERG/BAALC expression: a GRAALL study." Blood 118, no. 19 (November 10, 2011): 5099–107. http://dx.doi.org/10.1182/blood-2011-02-334219.
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Abstract Despite recent progress in the understanding of acute lymphoblastic leukemia (T-ALL) oncogenesis, few markers are sufficiently frequent in large subgroups to allow their use in therapeutic stratification. Low ERG and BAALC expression (E/Blow) and NOTCH1/FBXW7 (N/F) mutations have been proposed as powerful prognostic markers in large cohorts of adult T-ALL. We therefore compared the predictive prognostic value of N/F mutations versus E/Blow in 232 adult T-ALLs enrolled in the LALA-94 and Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) protocols. The outcome of T-ALLs treated in the pediatric-inspired GRAALL trials was significantly superior to the LALA-94 trial. Overall, 43% and 69% of adult T-ALL patients were classified as E/Blow and N/F mutated, respectively. Strikingly, the good prognosis of N/F mutated patients was stronger in more intensively treated, pediatric-inspired GRAALL patients. The E/B expression level did not influence the prognosis in any subgroup. N/F mutation status and the GRAALL trial were the only 2 independent factors that correlated with longer overall survival by multivariate analysis. This study demonstrates that the N/F mutational status and treatment protocol are major outcome determinants for adults with T-ALL, the benefit of pediatric inspired protocols being essentially restricted to the N/F mutated subgroup.
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Rotter, Gabriele, Isabel Fernholz, Sylvia Binting, Theresa Keller, Stephanie Roll, Benjamin Kass, Thomas Reinhold, Stefan N. Willich, Alexander Schmidt, and Benno Brinkhaus. "The effect of osteopathic medicine on pain in musicians with nonspecific chronic neck pain: a randomized controlled trial." Therapeutic Advances in Musculoskeletal Disease 12 (January 2020): 1759720X2097985. http://dx.doi.org/10.1177/1759720x20979853.
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Background: Nonspecific chronic neck pain (cNP) is common in adult violinists and violists and is often treated with osteopathic medicine (OM), although the effectiveness of this treatment has not been determined to date. This study aimed to evaluate the effectiveness and safety of OM in adult violinists and violists with cNP. Methods: In a two-armed randomized controlled single-center open trial, adult violinists and violists, including music students, with cNP (⩾12 weeks) were randomized to either five individualized OM sessions (OM group) or to no intervention (control group, CG) in the outpatient clinic for integrative medicine, Charité - Universitätsmedizin Berlin, Germany. All patients received a musicians’ medicine consultation and paracetamol on demand. The primary outcome parameter was the neck pain intensity on a visual analog scale (VAS, 0–100 mm, 0 = no pain, 100 = worst imaginable pain) after 12 weeks. Secondary outcomes included neck pain disability (Neck Disability Index, NDI, 0–100%) after 12 weeks. The last follow-up visit was after 52 weeks. Statistical analysis included analysis of covariance adjusted for respective baseline value. Results: Altogether, 62 outpatients were included [OM group ( n = 28), CG ( n = 34); 81% female; mean age, 41.6 ± 11.1 years; mean baseline neck pain, 55.9 ± 11.6 mm]. After 12 weeks, OM was associated with an improvement in the OM group versus the CG in neck pain on the VAS [14.6 mm (95% confidence interval 8.0; 21.2) versus 40.8 mm (34.7; 46.9), p < 0.001, Cohen’s d = 1.4], and neck pain disability as determined by the NDI [8.8% (6.7; 10.8) versus 17.2% (15.3; 19.1), p < 0.001]. Some improvements were maintained until 52 weeks of follow-up. No serious adverse events were observed. Conclusions: The results of this study suggest that OM might be effective in reducing pain intensity in adult violinists and violists with nonspecific cNP. Further studies should investigate the efficacy of OM in comparison with a sham procedure and with other effective therapy methods in high-quality multicenter trials. Trial registration: WHO Trial Registration https://apps.who.int/trialsearch/NoAccess.aspx?aspxerrorpath=/trialsearch/Trial2.aspx by German Clinical Trials Register DRKS00009258, Universal Trial Number (UTN): U1111-1173-5943.
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Kopp, Lisa M., Damon R. Reed, Safia K. Ahmed, Wendy Allen-Rhoades, Viswatej Avutu, Yen-Lin Chen, Lara E. Davis, et al. "Enrollment barriers of adolescents and young adults (AYA) on the non-chemotherapy arm of ARST1321." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e19214-e19214. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19214.
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e19214 Background: ARST1321(PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NCT02180867) was the first National Clinical Trials Network (NCTN) study co-developed by pediatric (COG) and adult (NRG Oncology) consortia anticipating enrollment of adolescent and young adult (AYA) cancer patients. ARST1321 had two treatment cohorts, enrolling patients ≥ 2 years of age to either chemotherapy (C) (chemoradiation ± pazopanib) or non-chemotherapy (NC) (radiation ± pazopanib) arms. It was anticipated adults would contribute the majority of enrollments on the NC arm based on prior enrollment patterns. While the C arm accrued as anticipated (with high enrollment of adults and children), the NC arm had low enrollment leading to premature closure. We report on AYA accrual (defined as 15-39 years) to the NC arm and a survey aiming to identify barriers to enrolling AYA patients onto ARST1321. Methods: Our survey was emailed to 161 adult, surgical, and radiation oncologists at large sarcoma centers. A link was sent to an online questionnaire via SurveyMonkey Inc. and responses were reviewed on their platform. Results: 33 patients enrolled on the ARST1321 NC arm, of which 24% were AYA. 25% of AYA enrollments were from non-COG adult cooperative groups. This trial arm was closed in October 2017 after 3.25 years of accrual below anticipated rates. The survey response rate was 31% with a 70% completion rate. Almost half of respondents were medical oncologists with most seeing 50-200 new sarcoma cases/year at an academic institution and 30% in a pediatric environment (divided equally between radiation and surgical oncologists). 70% of respondents have a joint collaboration with their pediatric oncology team with 23% having a joint clinic. 70% of respondents’ sites opened ARST1321 and anticipated 1-5 patients would be eligible for the NC cohort. However, 42% of respondents’ sites had zero patients enrolled on that arm. The most common reasons for not opening the study and/or not enrolling patients on the NC arm included: lack of interest, disagreement with the therapy, lack of a site investigator, premature study closure, patient/family decision, competing trials, insufficient reimbursement, and regulatory delays. Conclusions: Our survey highlights multiple barriers to enrollment of AYA onto cross-NCTN consortia clinical trials spanning the age spectrum. The information obtained will help inform investigators aiming to effectively design, enroll, and conduct similar trial efforts for AYA in the future.
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Pignatti, Francesco, Martin van den Bent, Desmond Curran, Channa Debruyne, Richard Sylvester, Patrick Therasse, Denes Áfra, et al. "Prognostic Factors for Survival in Adult Patients With Cerebral Low-Grade Glioma." Journal of Clinical Oncology 20, no. 8 (April 15, 2002): 2076–84. http://dx.doi.org/10.1200/jco.2002.08.121.
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PURPOSE: To identify prognostic factors for survival in adult patients with cerebral low-grade glioma (LGG), to derive a prognostic scoring system, and to validate results using an independent data set. PATIENTS AND METHODS: European Organization for Research and Treatment of Cancer (EORTC) trial 22844 and EORTC trial 22845 are the largest phase III trials ever carried out in adult patients with LGG. The trials were designed to investigate the dosage and timing of postoperative radiotherapy in LGG. Cox analysis was performed on 322 patients from EORTC trial 22844 (construction set), and the results were validated on 288 patients from trial 22845 (validation set). Patients with pilocytic astrocytomas were excluded from this prognostic factor analysis. RESULTS: Multivariate analysis on the construction set showed that age ≥ 40 years, astrocytoma histology subtype, largest diameter of the tumor ≥ 6 cm, tumor crossing the midline, and presence of neurologic deficit before surgery were unfavorable prognostic factors for survival. The total number of unfavorable factors present can be used to determine the prognostic score. Presence of up to two of these factors identifies the low-risk group, whereas a higher score identifies high-risk patients. The validity of the multivariate model and of the scoring system was confirmed in the validation set. CONCLUSION: In adult patients with LGG, older age, astrocytoma histology, presence of neurologic deficits before surgery, largest tumor diameter, and tumor crossing the midline were important prognostic factors for survival. These factors can be used to identify low-risk and high-risk patients.
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Petri, Kristin C. C., Paula M. Hale, Paul L. Hofman, and Lisbeth V. Jacobsen. "Liraglutide pharmacokinetics and exposure-response in pediatric patients with type 2 diabetes." Journal of Pediatric Endocrinology and Metabolism 33, no. 10 (August 18, 2020): 1289–92. http://dx.doi.org/10.1515/jpem-2020-0053.
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AbstractObjectivesBased on the ellipse trial, liraglutide was recently approved for use in pediatric patients with type 2 diabetes. We report the comparative exposure of liraglutide in pediatric vs. adult patients.MethodsIn this pharmacokinetic (PK) and exposure-response meta-analysis, data from two pediatric trials (including ellipse) and two adult trials of liraglutide were compiled (1,137 PK observations from 116 patients) to determine the impact of body weight, age and sex on liraglutide exposure. The exposure-response relationship for glycated hemoglobin (HbA1c) and body weight was compared between pediatric and adult patients. Additionally, the relationships between exposure and change from baseline in body mass index (BMI) and BMI standard deviation score (SDS) were assessed.ResultsThe same liraglutide dose showed comparable exposure levels in pediatric and adult patients. Body weight and sex were the most important covariates for liraglutide exposure. There was an increasing response with higher liraglutide concentrations, and greater reductions were observed from baseline in HbA1c at 26 weeks vs. placebo. A trend toward lower body weight, BMI and BMI SDS was observed at 26 weeks.ConclusionsThese results support use of the same liraglutide dosing regimen in children and adolescents, aged ≥10 years, as that used in adults.
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Sarvode, Supriya, Katherine Warren, David Reardon, and Kee Kiat Yeo. "EPID-35. CLINICAL TRIAL ENROLLMENT RATE AMONG ADOLESCENT AND YOUNG ADULTS WITH CENTRAL NERVOUS SYSTEM TUMOR AT DANA-FARBER CANCER INSTITUTE (DFCI)." Neuro-Oncology 22, Supplement_2 (November 2020): ii86. http://dx.doi.org/10.1093/neuonc/noaa215.353.
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Abstract BACKGROUND Adolescents and young adults (AYAs; 15–39 yrs.) are a population recognized as facing significant challenges in cancer care and research, characterized by historically poor participation in clinical trials. The clinical trial enrollment rate among AYAs with CNS tumor is unclear. We report the findings from our study evaluating the clinical trial enrollment rate of AYAs with CNS glioma at DFCI, comparing the rates between its affiliated adult and children’s hospitals. METHODS We performed a retrospective cohort study of patients with primary CNS glioma treated at our center between 2008–18. Eligible patients were identified using institutional databases at Boston Children’s Hospital and Brigham and Women’s Hospital. Manual chart review and data abstraction from the electronic medical record were performed to obtain key variables. Clinical trial enrollment rates were reported, followed by univariate and multivariate logistic regression models to identify factors affecting clinical trial enrollment. RESULTS In the adult setting, a total of 608 AYA patients with glioma were identified to meet our inclusion criteria and presented with a median age of 32 years (range:15–39). 92 out of 608 (15%) patients enrolled in a clinical trial during their treatment course. Within this cohort, tumor type was significantly associated with clinical trial enrollment, with higher-grade tumors associated with better enrollment rates (p< 0.001). On the contrary in the pediatric setting, a total of 52 AYA patients were identified from the children’s hospital, with a median age of 17.2 years (range:15–25.4) of whom, 19 out of 52 (36.5%) patients were enrolled on a clinical trial. CONCLUSION Clinical trial enrollment rate remains poor among AYAs with CNS tumors, with tumor type/histology grade associated with enrollment rate. Higher enrollment rates were seen among early AYAs treated at the children’s hospital.
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Ho, Phoenix A., Kenneth J. Kopecky, Todd A. Alonzo, Robert B. Gerbing, Kristen L. Miller, Julia Kuhn, Rong Zeng, et al. "Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG." Blood 118, no. 17 (October 27, 2011): 4561–66. http://dx.doi.org/10.1182/blood-2011-04-348888.
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Abstract IDH1 SNP rs11554137 was recently reported in association with poor prognosis in normal karyotype adult acute myeloid leukemia (AML). We aimed to determine the prevalence, clinical associations, and prognostic significance of SNP rs11554137 in unselected pediatric and adult AML patients. Diagnostic marrow specimens from 527 AML patients treated on the pediatric trial Children's Oncology Group-AAML03P1 (N = 253) or adult SWOG trials (N = 274) were analyzed for the presence of the SNP. SNP rs11554137 was present in 11% of all patients. SNP status had no prognostic impact on survival in pediatric patients. In adult AML, overall survival for SNP-positive patients was 10% versus 18% for SNP-negative patients (P = .44). Among the 142 adults who achieved complete remission, 5-year relapse-free survival was significantly worse for SNP-positive patients (0% vs 25%, P = .0014). However, among adults with normal cytogenetics, FLT3/ITD was present in 90% of SNP-positive patients versus 59% of SNP-negative patients (P = .0053). In multivariate analysis, adjusting for the effects of age, cytogenetics, and FLT3/ITD, the independent prognostic effect of SNP positivity was not statistically significant (hazard ratio = 1.72, P = .18). The clinical profile of SNP-positive patients suggests that SNP rs11554137 may have biologic effects that bear further investigation. The clinical trials in this study are registered at http://www.clinicaltrials.gov as #NCT000707174 and #NCT00899171.
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Ledson, M. J., Z. Wahbi, R. P. Convery, C. Cowperthwaite, D. P. Heaf, and M. J. Walshaw. "Targeting of dornase alpha therapy in adult cystic fibrosis." Journal of the Royal Society of Medicine 91, no. 7 (July 1998): 360–64. http://dx.doi.org/10.1177/014107689809100705.
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Although dornase alpha (recombinant human DNase) can thin the viscid pulmonary secretions of cystic fibrosis (CF), clinical trials in groups of unselected patients have shown only modest average improvements in pulmonary function. The product is very expensive, so in conjunction with purchasers we designed selection criteria and a protocol for a 2-week trial to target CF individuals who might gain most benefit. Treatment was to be continued in those showing ≥10% improvement in pulmonary function. Those who had a trial of dornase alpha were followed up for 2 years. Of 25 patients who had a 2-week trial of dornase alpha, 17 met the criteria for continuation (average gain in forced expiratory volume 37%). The 11 of these who were still alive at 2 years had a greater initial average FEV1 improvement than those who had died (45% versus 22%), and still had an average improvement of 31% at 2 years. The 8 patients who did not meet the criteria for continuation were older and had required fewer intravenous antibiotic courses. All these were alive at 2 years with unchanged clinical indices. This method of selection for dornase alpha treatment allows targeting to those who gain most benefit without disadvantaging the remaining patients. Furthermore, production of such guidelines in conjunction with purchasers obviates funding difficulties and allows rational prescribing.
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Fruchter, Oren, Yair Manevich, Uri Carmi, Dror Rozengarten, and Mordechai R. Kramer. "Prospective Randomized Trial Evaluating Ketamine for Adult Bronchoscopy." Journal of Bronchology & Interventional Pulmonology 24, no. 4 (October 2017): 279–84. http://dx.doi.org/10.1097/lbr.0000000000000399.
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Hawley, N., H. Brunet, and J. Miller. "A-48 The Role of Processing Speed in Verbal and Nonverbal Learning within a Clinical Sample of Older Adults." Archives of Clinical Neuropsychology 34, no. 6 (July 25, 2019): 907. http://dx.doi.org/10.1093/arclin/acz034.48.
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Abstract Objective Prior research revealed that processing speed predicts nonverbal learning in healthy older adults (Tam & Schmitter-Edgecombe, 2013). This study aims to examine the role of processing speed in both verbal and nonverbal learning in a clinical sample. We expect that processing speed will lend the most variance to the initial learning trials. Method Records from 718 patients were reviewed (mean age = 74). Hierarchical regression analyses were conducted using Brief Visuospatial Memory Test –Revised (BVMT-R) and Hopkins Verbal Learning Test –Revised (HVLT-R) learning trials as outcome variables. Demographics were entered in a first step followed by BVMT-R copy or Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span –longest digit span forward raw score, to account for visuoconstruction or simple auditory attention for nonverbal and verbal learning outcomes respectively. A processing speed composite of sample-standardized raw scores was entered in a final step. Results Processing speed accounted for 5.4% of the variance in BVMT-R trial 1, 7.5% of the variance in trial 2, and 8.5% of the variance in trial 3, all p < .001. Processing speed accounted for 6.6% of the variance in HVLT-R trial 1, 11.1% of the variance in trial 2, and 11.5% of the variance in trial 3, all p < .001. Conclusions Processing speed significantly predicted all verbal and nonverbal learning trials. Contrary to our hypotheses, processing speed actually had a greater contribution during subsequent learning trials. These findings have implications for evaluating memory performance in patients with syndromes where processing speed is typically affected (e.g., cerebrovascular disease, Parkinson’s disease).
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Marks, Asher, and Ranjit Bindra. "CLRM-03. BGB-290 AND TEMOZOLOMIDE IN TREATING ISOCITRATE DEHYDROGENASE (IDH)1/2-MUTANT GRADE I-IV GLIOMAS – A NOVEL MODEL OF AYA TRIAL DEVELOPMENT AND DEPLOYMENT." Neuro-Oncology Advances 3, Supplement_4 (September 21, 2021): iv1. http://dx.doi.org/10.1093/noajnl/vdab112.002.
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Abstract DESCRIPTION The lack of enrollment of AYA patients on clinical trials is well documented and multivariant. Here we present the basic science, examination of its relevance to the AYA population specifically, and the parallel deployment of two international clinical trials via a pediatric neuro-oncology and adult brain tumor consortium. DISCUSSION In February of 2017, the laboratory of Ranjit Bindra, MD, PhD, published a manuscript describing the finding that tumors with IDH1/2 mutations induce a BRCAness state leading to PARP inhibitor (PARPi) sensitivity and synergistic interactions with temozolomide chemotherapy [2]. Despite IDH1/2 mutations being rare in the pediatric high-grade glioma population, three independent groups confirmed that the incidence is significantly increased to ~30% in the adolescent and young adult (AYA) population. Upon discovery of a high blood-brain-barrier penetrant, high potency PARPi by BeiGene Pharmaceuticals, an international trial was launched through the Pacific Pediatric Neuro-Oncology Consortium (PNOC) [3] to test this drug in an AYA specific trial recruiting patients ages 13 to 25, with a concurrent trial being run for patients older than 25 years of age through the Adult Brain Tumor Consortium (ABTC) [4]. While most trials that enroll AYA patients are forced to assess them as a unique cohort in post-analysis, if at all, the PNOC trial mentioned above was designed from the ground up with the AYA population in mind. It has allowed us to base initial dosing, recruitment strategies, psychosocial assessments, and outcomes, specifically on the AYA population. Ultimately, we expect their distinctive biology to yield unique results when compared to the ABTC trial. We propose that this is a model that could potentially be replicated in other disease processes and early phase drugs with the buy-in of the pharmaceutical industry and early phase consortiums. Acknowledgements: BeiGene Pharmaceuticals, PNOC, ABTC, CureSearch, Gateway Foundation
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Morshed, Ramin, Sheantel Reihl, Sofia Kakaizada, Eric Zhang, Jacob Young, Jennifer Clarke, Nicholas Butowski, et al. "ACTR-35. A STUDY OF RACE AND SOCIOECONOMIC STATUS IMPACTING THERAPEUTIC CLINICAL TRIAL ENROLLMENT IN ADULT GLIOMAS PATIENTS." Neuro-Oncology 21, Supplement_6 (November 2019): vi21. http://dx.doi.org/10.1093/neuonc/noz175.078.
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Abstract OBJECT Under-enrollment in clinical trials significantly limits valid analyses of clinical interventions and generalizability of findings. Often it results in premature study termination, with estimates of 22% to 50% of clinical trials terminated due to poor accrual. Currently, there are limited reports addressing the influence of race/ethnicity and socioeconomic status on clinical trial enrollment in patients with adult glioma. The goal of this study was to determine if these factors impact clinical trial participation for glioma patients. METHODS 852 adult patients were identified from the UCSF Tumor Board Registry and analyzed to determine the rate of therapeutic clinical trial consideration, tumor board recommendation, and study enrollment based on clinical reports in their electronic medical records. RESULTS At initial diagnosis, 30.7% and 18.0% of glioma patients were recommended and enrolled in a therapeutic clinical trial, respectively. At recurrence, 38.7% and 25.3% of patients were recommended and enrolled in a clinical trial, respectively. Nineteen percent of the study population belonged to a NIH-designated underrepresented minority group; Asian/Pacific-Islander comprising 10.3% overall. On univariate analysis, only in-state location, distance to the hospital, and WHO grade were associated with consideration, recommendation, and enrollment at initial diagnosis and recurrence. Minority status, insurance type, median household income, and percent below poverty were not associated with clinical trial recommendation or enrollment. CONCLUSION Race and socioeconomic status did not impact clinical trial consideration, tumor board recommendation, or study enrollment. Our results do not support the premise that provider decisions are impacted by biases based on minority or socioeconomic status.
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Kusuma, Arditya Damar, and Anggoro Budi Hartopo. "Polyphenol in reducing cardiovascular outcomes in adult: A Rapid Review and Meta Analysis." ACI (Acta Cardiologia Indonesiana) 7, no. 1 (March 23, 2021): 36–47. http://dx.doi.org/10.22146/jaci.v7i1.1152.
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Abstract
Objectives
This review has an objective to determine the effectiveness of polyphenol intervention for the primary prevention of cardiovascular disease events and others surrogate endpoint which may correlate with cardiovascular disease events
Data Sources
These electronic databases were used to search the appropriate trials: MEDLINE (OvidSP, 1946 to March week 2 2020); The Cochrane Central Register of Controlled Trials (CENTRAL,week 2 March 2020). We only used English language trials that were available on these two databases.
Review Methods
We chose randomized controlled trials both in healthy or having high risk of cardiovascular diseases. Polyphenol as intervention was described as any food or drink that has polyphenol or its derived substance as main content. Placebo or no intervention is the comparison group. Cardiovascular clinical events and surrogate endpoints or cardiovascular disease risk factors are included in the outcome. Revman 5.5 software was used to analyze all the trials and to assess the risk of bias each trial. We selected random or fixed effects depend on the heterogeneity between trials in the meta analysis.
Results
Seven trials were included with 49200 participants randomized. Heterogeneity was shown between trials regarding the characteristic of participants, types of polyphenol intervention, and follow up periods. Cardiovascular event outcomes are only available in one trial (Howard et al 2006), with the intervention not clearly defined as polyphenol but increasing fruit and grain consumption. This trial shows no evidence was shown on fatal and non-fatal cardiovascular outcome by consuming more fruit and grain with 8 years mean of follow up. By analyzing remaining trials, which provide surrogate endpoints or cardiovascular risk factors, there is no evidence that polyphenol intervention reduce systolic and diastolic blood pressure, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol level, and triglyceride level. However, reduction total cholesterol level was shown from the baseline (MD -5.41 mg/dl, 95% CI -8.21 to -2.62, P=0.0001). Subgroup analyses were done with dividing the trials that involve women only and both men and women. This analysis shows the reduction of both systolic (MD -2.78 mmHg, 95% CI -5.47 to -0.08, P=0.04) and diastolic blood pressure (MD -2.59 mmHg, 95% CI -4.84 to -0.34, P=0.02) in trials involving both men and women. A sensitivity analysis was done by excluding the trials with risk of bias with no different results effect. Moreover, not any trials reported adverse events of polyphenol.
Author’s Conclusion
Due to the limitation evidence or trial available, we could not obtain meta analysis on the primary outcome. Nevertheless, this review suggests that polyphenol intervention does show favorable effect on surrogate endpoints which was total cholesterol levels. Besides, systolic blood pressure and diastolic blood pressure in trials which involves both men and women also shown an improvement. The high heterogeneity in this review also suggests that more evidence are needed to assess the effectiveness of polyphenol intervention in reducing cardiovascular event outcomes and risk factors in the future.
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Marche, Tammy A., Jason J. Jordan, and Keith P. Owre. "Younger Adults Can Be More Suggestible than Older Adults: The Influence of Learning Differences on Misinformation Reporting." Canadian Journal on Aging / La Revue canadienne du vieillissement 21, no. 1 (2002): 85–93. http://dx.doi.org/10.1017/s0714980800000660.
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ABSTRACTThe aim of the present investigation was to determine whether differences in the strength of original information influence adult age differences in susceptibility to misinformation. One-half of the younger and older adults watched a slide sequence once (one-trial learning) that depicted a theft, whereas the remaining participants viewed the slide sequence repeatedly to ensure that all critical details were encoded (criterion learning). Three weeks later and immediately prior to final testing, participants were asked questions that contained misleading information. As expected, the degree of initial learning influenced age differences in misinformation reporting. That is, when event memory was poorer for older than younger adults (in the criterion learning condition), older adults were more susceptible to misinformation than younger adults. However, when memory of the event was poor (in the one-trial learning condition), the younger adults reported more misled details than the older adults, possibly because the younger adults had better memory for the misleading information. Therefore, strength of initial memory influences the extent and direction of adult suggestibility and helps explain the discrepancy found across studies in this area.
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Ickovics, Jeannette R., Ann Cameron, Robert Zackin, Roland Bassett, Margaret Chesney, Victoria A. Johnson, Daniel R. Kuritzkes, et al. "Consequences and Determinants of Adherence to Antiretroviral Medication: Results from Adult Aids Clinical Trials Group Protocol 370." Antiviral Therapy 7, no. 3 (April 1, 2001): 185–93. http://dx.doi.org/10.1177/135965350200700308.
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Objectives (1) To document rates and patterns of adherence from enrollment until week 24 of an AIDS clinical trial; (2) to examine the association of adherence to clinical end-points including plasma HIV-1 RNA level and CD4 cell count; and (3) to identify predictors of adherence from clinical, behavioural, psychosocial and demographic factors. Design Sub-study of a multicentre, randomised, open-label, comparison-controlled trial; 21 collaborating units of the Adult AIDS Clinical Trials Group. Observational, prospective analysis. Methods Ninety-three subjects with baseline plasma HIV-1 RNA levels >500 copies/ml, who completed clinical assessment, plasma HIV-1 RNA titres and CD4 cell counts at study entry, weeks 2, 4 and every 4 weeks thereafter until week 24. All patients were antiretroviral-experienced but were naive to non-nucleoside reverse transcriptase inhibitors and protease inhibitors. Self-reported adherence to antiretroviral therapies prescribed as part of the trial was assessed every 4 weeks from trial, week 4 until week 24. Results Average adherence was high, with 63% of subjects reporting >95% adherence across the trial. However, there was a significant decline in adherence over time on trial. After controlling for potential confounding variables, patients who were less than 95% adherent to medications were 3.5-times more likely to have treatment failure (HIV-1 RNA >50 copies/ml) than subjects with adherence rates of 95–100%. The strongest predictor of adherence was adverse clinical events (for example, dermatological, gastrointestinal symptoms): patients with adverse events were 12.8-times less likely to have 95–100% adherence. Other clinical, demographic, psychosocial and behavioural factors were also significant predictors of adherence. Conclusions Adherence influences virological outcome even in AIDS clinical trials where overall adherence rates are high and should therefore be monitored in future trials. Intervention may be warranted to enhance adherence for subjects who have early toxicities, express concern about taking medications as directed, and for women and minorities.
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Chmiel, Stephen M., Jim O. Wolk, and John D. Wollam. "Foliar Potato Insecticide Trial, 1983." Insecticide and Acaricide Tests 10, no. 1 (January 1, 1985): 130. http://dx.doi.org/10.1093/iat/10.1.130.
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Abstract Potatoes were planted on 27 Apr at the Mobay Research Farm, Howe, IN. Plots measured 6 ft (2 rows) x 25 ft with 4 replicates in a randomized complete block design. All treatments were applied with a CO2 pressurized tractor-mounted boom sprayer (3 hollow-cone nozzles/row) at 26 psi and 50 gpa on 17 Jun, 11 Jul, and 19 Jul. Efficacy data on Colorado potato beetle (CPB) included larval and adult counts, and defoliation ratings which reflected larval feeding (30 Jun) and additional feeding due to adult emergence on 15 Jul. Green peach aphid (GPA) and potato leafhopper (PLH) control was evaluated by counting the total number of insects on 10 leaves/plot.
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Moskop, Amy, Ke Yan, Sarah K. Dobrozsi, and Julie Panepinto. "Comparison of Health Outcomes in Adolescent and Young Adults (AYA) Oncology Patients Treated at a Pediatric Versus Adult Institute." Blood 134, Supplement_1 (November 13, 2019): 4743. http://dx.doi.org/10.1182/blood-2019-121616.
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BACKGROUND Overall survival for adolescent and young adult (AYA) cancer population, ages 15 to 39 years, demonstrated minimal improvement during the last several decades. Potential factors influencing inferior outcomes within this group include the complex biology of AYA cancers, lower rates of clinical trial enrollment, the significant toxicities caused by therapies, and unmet psychosocial needs. AYA patients can often be treated in either pediatric or adult institutions. The type of institution where they receive treatment is influenced by age, type of cancer, and distance from a pediatric oncology center. There are concerns that differences in care between pediatric and adult treatment settings are influencing the slow progress in improving outcomes. Acute care utilization might reflect the burden of toxicities and access to care, which might vary based on treatment setting. There is limited research suggesting that AYAs treated at pediatric institutes are more likely to be enrolled in clinical trials. The AYA population also has challenging psychosocial needs and it is unknown if there is a difference in how those needs are addressed in different treatment settings. The objective of this study was to examine whether there are differences in clinical trial enrollment, acute care utilization, and psychosocial support between AYA oncology patients treated at a pediatric versus an adult facility. Our hypothesis was that AYAs treated at a pediatric facility will have increased enrollment in clinical trials, less acute care utilization, and more psychosocial referrals compared to AYAs treated at an adult facility. METHODS We conducted a retrospective cohort study of patients ages of 15 to 39 years who were diagnosed with a hematologic malignancy (acute lymphoblastic leukemia (ALL), acute myelocytic leukemia (AML), Hodgkin lymphoma (HL) and Non-Hodgkin Lymphoma (NHL)) and were cared for at a pediatric or adult facility during the years 2013-2017. The primary health outcomes examined were acute care utilization and psychosocial resources utilized, based on a patient's exposure time (defined as one year from diagnosis or 1 month after completion of therapy, whichever came first). Data were analyzed using SAS 9.4. To compare the health outcomes between patients treated at the two facilities, the Chi-square test or Fisher's exact test was used for categorical variables. For continuous variables, due to the skewness of the data, a log transformation was applied to the length of stay (LOS) variable, and then the Student's t-test was used. The Mann-Whitney test was used for the other continuous variables. This study was approved by the Children's Hospital of Wisconsin Institutional Review Board. RESULTS A total of 196 patients were treated as either newly diagnosed or relapse/progressive patients who received care at the pediatric or adult treatment facilities. Leukemia patients treated at a pediatric facility were more likely to be enrolled on a clinical trial than patients treated at an adult facility (84% vs 22%, p<0.0001). There was no statistically significant difference in enrollment in clinical trials for lymphoma patients at both treatment facilities (4% vs 8%, p=0.68) as shown in Table 1. There was no significant difference in acute care utilization for ED visits or inpatient hospitalizations for all diagnoses for the pediatric and adult facilities. Both ALL and HL patients had more ICU admissions per month at the pediatric facility compared to the adult facility (ALL: mean 0.25 vs 0.05, p=0.021; HL: mean 0.03 vs 0, p=0.0027). ALL and HL patients had longer hospitalization LOS at the adult facility (ALL p=0.020, HL p=0.014) There were more referrals for psychology, social work or case management and palliative care in the pediatric versus adult facility (p<0.0001, p=0.011, p<0.0001, respectively). CONCLUSION For AYA patients treated at a pediatric institute, leukemia patients have higher rates of clinical trial enrollment and all patients receive more psychosocial support compared to AYA patients treated at an adult institute. There was no difference in acute care utilization for ED visits or hospitalizations between patients treated at a pediatric or an adult facility. Patients with ALL and HL have more ICU admissions but overall shorter hospital LOS at the pediatric institution. Further work to determine the impact of these findings on the long-term outcomes and survival of AYA patients is needed. Disclosures Panepinto: NIH: Research Funding.
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Kanapuru, Bindu, Harpreet Singh, Janice Kim, and Paul Gustav Kluetz. "Patient-reported outcomes (PRO) in cancer trials submitted to the FDA from 2012-2015." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): e14024-e14024. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e14024.
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e14024 Background: PRO measures are commonly assessed in cancer trials. We reviewed the PRO strategy, tools and trial designs for new drug applications (NDA) and biologics license applications (BLA) submitted to FDA over a 4 year period. Methods: A review of protocols and clinical study reports for original NDA and BLA applications submitted to the Office of Hematology and Oncology Products between 2012 and 2015 to support initial approval for adult malignant hematology and oncology conditions was done. We reviewed applications for inclusion of PRO data, trial design, type of PRO measure employed and statistical analysis methods. Results: Forty three trials were submitted to support 40 original NDA or BLA approvals targeting adult malignancies between 2012 and 2015. Of these 43 trials, 17/43 (40%) were accelerated approval, 26/43 (60%) were randomized, 17/43 (40%) were single arm and 27/43 (63%) were open label trials. Sponsors documented the incorporation of PRO assessments in 28/43 (65%) trials. For trials that included PRO assessments, 22/28 (79%) were randomized controlled trials, 6/28 (21%) were single arm and 17/28 (61%) were open label studies. The most common PRO instruments used were the EORTC-QLQ-C30 (15/28; 54%), EQ-5D (13/28; 46%) and various FACIT measures (8/28; 29%). Although 20/28 (71%) trials had PRO measures listed as a secondary endpoint, only 1 trial included PRO endpoints in the statistical testing hierarchy. Conclusions: PRO measures are often employed in randomized controlled cancer trials; however accelerated approval is common in oncology and trial designs are increasingly open label and single arm. Patient-focused drug development efforts will need to identify clinical trial objectives and analysis methods for PRO measures to describe symptoms and function that are suitable for these contexts. Descriptive PRO data on the tolerability of an anti-cancer agent may be one objective that is relevant across trial contexts. To support a claim of superiority, PRO endpoints should be adjusted for multiplicity by inclusion in the statistical hierarchy.
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Bhut, JB, DV Khanpara, AM Bharadiya, and RB Madariya. "Effectiveness of different storage bags against Caryedon serratus (Oliver) (Coleoptera: Bruchidae) in storage condition." Journal of Phytopharmacology 10, no. 6 (December 25, 2021): 520–24. http://dx.doi.org/10.31254/phyto.2021.10616.
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Laboratory experiments on effectiveness of different storage bags against the groundnut Bruchid, Caryedon serratus in storage condition was carried out at Main Oilseeds Research Station, Junagadh Agricultural University, Junagadh during 2016 and 2017. All the treatments were significantly superior over untreated check (i.e., Traditional jute gunny bags). Results of the experiment indicated that the lowest per cent pod damage was recorded in the treatments of high-density polythene (HDPE) bags (Adults unreleased), polythene layered gunny bags (Adults unreleased), fertilizer bags (Adults unreleased) and triple layered gunny bags (Adult unreleased) at 30, 60, 90 and 120 days days of trial installation. The high-density polythene (HDPE) bags (Adult unreleased) have also higher net gain as well as ICBR (1: 52.52) followed by high density polythene (HDPE) bags (Adult released) (1: 43.99) and polythene layered gunny bags (Adult unreleased) (1: 30.01).
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Jalaludin, Muhammad Yazid, Margarita Barrientos-Pérez, Mona Hafez, Jane Lynch, Naim Shehadeh, Serap Turan, and Daniel Weghuber. "Recommendations for improving clinical trial design to facilitate the study of youth-onset type 2 diabetes." Clinical Trials 17, no. 1 (August 26, 2019): 87–98. http://dx.doi.org/10.1177/1740774519870190.
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Background The prevalence of type 2 diabetes is increasing in youths and differs from adult-onset type 2 diabetes in its characteristics and progression. Currently, only two drugs are approved for youth-onset type 2 diabetes and many patients are not meeting glycemic targets. Clearly, there is an urgent need to complete clinical trials in youths with type 2 diabetes to increase the therapeutic choice for these patients. However, factors such as limited patient numbers, unwillingness of patients to participate in trials, failure to meet strict inclusion and exclusion criteria, and poor clinic attendance have limited the size and number of trials in this complicated patient demographic. Recommendations This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients’ participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population. Conclusions Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.
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Watson, R. N., J. P. J. Eerens, and L. T. Davis. "Clover root weevil feeding and larval numbers on white and red clover seedlines." New Zealand Plant Protection 55 (August 1, 2002): 252–57. http://dx.doi.org/10.30843/nzpp.2002.55.3948.
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Two adjacent field trials were established in pasture to assess the relationship between clover vigour and clover root weevil (Sitona lepidus; CRW) populations Trial 1 contained 31 white clover and three red clover seedlines Trial 2 evaluated nine white clover seedlines selected for field vigour against clover nematodes All seedlines were visually scored for weevil adult feeding and plant vigour in summer and autumn In winter selected seedlines representative of the vigour range across the trials were sampled for CRW larval numbers and root weight There was a direct relationship between clover vigour in April and the number of CRW larvae establishing on seedlines A similar relationship was evident for CRW larvae per gram of root in June The results suggest that high performing clover lines such as Grasslands Kopu II were able to maintain productivity in spite of feeding pressure by CRW (tolerance) rather than by the suppression of CRW adults egg laying or larval numbers (resistance)
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Reed, Damon R., Arash Naghavi, and Odion Binitie. "Sarcoma as a Model for Adolescent and Young Adult Care." Journal of Oncology Practice 15, no. 5 (May 2019): 239–47. http://dx.doi.org/10.1200/jop.18.00684.
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Sarcomas occur across all ages and are relatively abundant in the adolescent and young adult populations compared with older adults. Because of an overall rarity combined with a broad diversity of diagnoses, expertise is often concentrated in comprehensive cancer centers. The sarcoma model of care is an excellent model for overall adolescent and young adult care. We summarize some of the natural advantages of the field for developing adolescent and young adult programs, review management and referral touchpoints, and summarize recent biologic and clinical trial insights that have affected sarcoma management recently.
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Gajra, Ajeet, Marjorie E. Zettler, Eli G. Phillips, and Bruce Feinberg. "Age-Based Disparities in Clinical Trials Supporting FDA Approval of Therapies for Hematologic Malignancies." Blood 136, Supplement 1 (November 5, 2020): 21–22. http://dx.doi.org/10.1182/blood-2020-142064.
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Introduction: Older adults comprise the largest proportion of patients diagnosed with hematologic malignancies, with most new cases occurring in adults age 65 years and older. The under-representation of older adults in oncology clinical trials has been previously described, however data specific to hematologic malignancy trials is sparse. We conducted an analysis of the trials supporting Food and Drug Administration approval of new hematologic malignancy therapies over a 5-year period to evaluate the median age of participants and compared it to the real-world age distribution for the respective malignancy. Methods: Prescribing information for novel new hematologic malignancy therapies that were first approved for an indication in adult patients between 2015 and 2019 was reviewed for the median age in the evaluable population of the supporting clinical trials. Pediatric indications were excluded. Median age estimates among adults for each indication were obtained from the Surveillance, Epidemiology and End Results database. The difference in median age (DMA) was calculated for each trial by subtracting the median age in the disease population from the median age in the trial (Ludmir et al, JAMA Onc 2019). Additional details on trial protocols were obtained from approval packages accessed in the Drugs@FDA database and FDA's Office of Tissues and Advanced Therapies approvals website. Data are presented using descriptive statistics. Results: A total of 22 hematological malignancy therapies were approved based on 26 trials, with 6033 patients in the evaluable populations. Less than half of the trials were phase 3 (10; 38%) or were randomized with a control group (11; 42%). The median age of the trial participants was a mean of 3.8 years younger than the median age of the disease populations (95% CI: −6.0 to −1.6 years; p<0.01). By indication (Table), acute myeloid leukemia trials most often enrolled younger participants (mean DMA -7.8 years), followed by large B-cell lymphoma trials (mean DMA -7.0 years). The protocols for the majority of the trials (24; 92%) did not specify upper age limits, however most required an ECOG performance status ≤2, with only 2 trials (8%) permitting ECOG status 0-3. All trials had eligibility restrictions related to comorbidities, organ function, or hematopoietic function. Conclusions: The median age of hematologic malignancy clinical trial participants was nearly 4 years younger than their respective disease populations, despite few trial protocols having upper age limits. Poor performance status, the presence of comorbidities, or organ/hematopoietic impairment may have contributed to older patients' ineligibility to participate in the trials. Adequate representation in clinical trials is critical to evaluate the safety and efficacy of new therapies in the patient population who will eventually receive them. Given the inherent limitations of clinical trial design and accrual on older patient inclusion, post-approval real-world research is needed to understand the effect of these therapies on older adults. Disclosures Gajra: Cardinal Health: Current Employment. Zettler:Cardinal Health: Current Employment. Phillips Jr.:Cardinal Health: Current Employment. Feinberg:Cardinal Health: Current Employment.