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Ying, Xiangji, and Stephan Ehrhardt. "Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials." JAMA Network Open 6, no. 9 (September 14, 2023): e2333642. http://dx.doi.org/10.1001/jamanetworkopen.2023.33642.
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ImportancePilot trials often lead to study design changes in subsequent full-scale trials. Yet, it remains unclear whether these modifications improve the feasibility of the larger trial.ObjectiveTo compare feasibility estimates between pilot and full-scale trials and identify pilot trial characteristics and modifications associated with equivalent or improved feasibility in the full-scale trial.Design, Setting, and ParticipantsThis cohort study used pilot trials published between January 2005 and December 2018 and their corresponding full-scale trials. PubMed was searched for trials on February 19, 2022.ExposuresPilot trial characteristics and postpilot trial design modifications.Main Outcomes and MeasuresThe outcome of interest was difference in 3 feasibility parameters: successful screening probability, enrollment rate, and retention probability. These metrics were defined as equivalent or improved if the full-scale trial’s estimate was within or exceeding 10% of the pilot trial’s estimate.ResultsA total of 249 pairs of pilot and full-scale trials were analyzed, with 43%, 77%, and 82% of full-scale trials having equivalent or improved successful screening probabilities, enrollment rates, and retention probabilities, respectively. When pilot trials used feasibility progression criteria (relative risk [RR], 1.94; 95% CI, 1.02-5.97) and maintained masking for participants (RR, 1.82; 95% CI, 1.04-4.33) or health care practitioners (RR, 1.81; 95% CI, 1.03-3.97) consistent with the full-scale trial, the likelihood of achieving equivalent or improved screening success in full-scale trials increased. Increasing study sites after the pilot was associated with higher likelihood of equivalent or improved enrollment rates (RR, 1.03; 95% CI, 1.01-1.08). Adding extra content to the intervention (RR, 0.82; 95% CI, 0.66-0.98), changing to active control (RR, 0.74; 95% CI, 0.48-0.99), administrating the control treatment more frequently (RR, 0.60; 95% CI, 0.29-0.93), different follow-up lengths (RR, 0.85; 95% CI, 0.73-0.97), and more follow-up visits (RR, 0.86; 95% CI, 0.75-0.98) were associated with lower likelihood of equivalent or improved retention probability in the full-scale trial.Conclusions and relevanceIn this cohort study of pilot and full-scale trial pairs, pilot trial characteristics and postpilot modifications had varying associations with full-scale trial’s feasibility. If full-scale trials planned for masking, it was desirable to use it in the pilot. Modifications increasing participant burden might decrease full-scale trial feasibility. Trialists and funders should consider both pilot trial data and proposed design changes when assessing full-scale trials.
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Seow, Hsien-Yeang, Patrick Whelan, Mark N. Levine, Kathryn Cowan, Barbara Lysakowski, Brenda Kowaleski, Anne Snider, Rebecca Y. Xu, and Andrew Arnold. "Funding Oncology Clinical Trials: Are Cooperative Group Trials Sustainable?" Journal of Clinical Oncology 30, no. 13 (May 1, 2012): 1456–61. http://dx.doi.org/10.1200/jco.2011.37.2698.
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Purpose Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. Methods We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. Results Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an “l” shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). Conclusion The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.
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Van Der Weyden, Martin B. "Trials on trial." Medical Journal of Australia 175, no. 5 (September 2001): 241. http://dx.doi.org/10.5694/j.1326-5377.2001.tb143553.x.
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Nelson, Mark. "Trials on trial." New Scientist 209, no. 2800 (February 2011): 30. http://dx.doi.org/10.1016/s0262-4079(11)60384-9.
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Olsen, Hannah, Pei-Chi Kao, Caleb Richmond, David Stephen Shulman, Wendy B. London, and Steven G. DuBois. "Statistical fragility of findings from randomized phase 3 trials in pediatric oncology." Journal of Clinical Oncology 42, no. 16_suppl (June 1, 2024): e23003-e23003. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e23003.
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e23003 Background: The fragility index (FI) and survival-inferred fragility index (SIFI) have been proposed as adjunctive metrics to facilitate interpretation of p-values in clinical trials. FI/SIFI is the number of patients on a positive (p < 0.05) trial’s experimental arm who would need to switch from “responder/non-event” to “non-responder/event” to cause p > 0.05. Fragility indices have been reported previously in medical oncology, with median values < 10 often seen in the literature. This metric has not been studied in pediatric oncology trials. Methods: PubMed was used to identify randomized phase 3 pediatric oncology trials published between 1980-2020. We report trial characteristics and calculate FI for trials with a binary outcome and SIFI for trials with a time-to-event outcome. We also report the fragility quotients (FQ and SFQ) to normalize FI and SIFI relative to trial size. Results: 113 trials included sufficient data for analysis. The median FI for trials with a binary outcome (n = 40) was 4.5 (range: 1-33). The median SIFI for trials with a time-to-event outcome (n = 73) was 13 (range: 0-61). The FI or SIFI was less than the number of patients lost to follow-up in 25% of 36 trials. Median FQ = 0.026 and SFQ = 0.03, indicating that revised outcome in 2.6% or 3% of trial participants would be sufficient to alter the trial conclusion. FQ and SFQ did not significantly vary according to trial characteristics. While sample sizes increased over time (mean 187, 1980s; mean 437, 2010s), FQ and SFQ remained stable between 2-3%. Conclusions: The statistical conclusions of pediatric oncology phase 3 trials hinge on a relatively small number and proportion of patients. Despite sample size limitations of low prevalence diseases, pediatric cancer trials appear similarly or less fragile than adult oncology trials. Fragility was similar for large versus small trials and remained constant over four decades. [Table: see text]
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Singh, Jerome Amir. "Adaptive clinical trials in public health emergency contexts: ethics considerations." Wellcome Open Research 8 (March 23, 2023): 130. http://dx.doi.org/10.12688/wellcomeopenres.19057.1.
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While Adaptive Clinical Trials (ACTs) have grown in prevalence, prominence, and impact, the ethical issues implicit in such trial designs, particularly in the context of public health emergencies, have been afforded relatively scant attention. This work argues that the ethical dimensions of ACTs should be considered at trial conception, factored into the trial’s design, and subject to ongoing evaluation during the trial’s conduct.
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Krischak, Madison, Merrick Bank, Mary Byrnes, and Kristian Stensland. "The frequency of use and enrollment impact of patient-centered outcomes in prostate cancer clinical trials." Journal of Clinical Oncology 42, no. 4_suppl (February 1, 2024): 115. http://dx.doi.org/10.1200/jco.2024.42.4_suppl.115.
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115 Background: Cancer treatments should help patients live either longer or better by improving patient quantity or quality of life. However, some trial endpoints do not correlate with overall survival, and are not noticeable to patients. Selecting endpoints for clinical trials that reflect these goals could improve the discovery process by ensuring trial results are of direct interest to patients, and perhaps by improving enrollment rates to trials. However, how frequently prostate cancer clinical trials use patient-centered outcomes, and how outcome type impacts trial enrollment, is unknown. Methods: On October 23, 2022, we queried ClinicalTrials.gov for full text records of phase 2-3 prostate cancer trials started after January 1, 2007. We extracted primary outcomes and other trial characteristics using a custom Python script. Two reviewers categorized each outcome into categories (e.g., overall survival, response rate, patient reported measure). As previously studied, the only valid surrogate for overall survival is metastasis-free survival. We considered these two outcomes or any outcome directly noticeable to a patient to be a patient-centered outcome. For completed or terminated trials, we defined ‘sufficient accrual’ as attaining 85% of a trial’s goal enrollment. We identified associations between trial outcome types and sufficient trial enrollment with chi-square tests and logistic regression. Results: Of 1,717 prostate cancer trials, only 37% used a patient-centered outcome, with 6% using overall or metastasis-free survival. Among 318 Phase 3 trials, 49% used a patient-centered outcome and 26% used overall or metastasis-free survival. Of 731 completed or terminated prostate cancer trials, 55% of trials and 68% of phase 3 trials reached sufficient enrollment (85% of enrollment goal). On multivariable analysis, trials with an overall survival endpoint had higher odds of sufficient enrollment (OR 8.0 [95% CI 2.2-33.5], p < 0.01), but trials with any patient-centered outcome had lower odds of sufficient enrollment (OR 0.25 [95% CI 0.11-0.54], p < 0.01). Conclusions: Less than half of prostate cancer trials use an outcome that is clearly patient-centered (i.e., affecting overall survival or an outcome noticeable to a patient). Further work is needed to clarify the use, understanding, and effect of outcome selection in cancer trials. Realigning trial efforts with patient-centered goals could improve the efficiency, productivity, and applicability of clinical trials.
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Vulto, Arnold G. "Clinical trials on trial." European Journal of Hospital Pharmacy 19, no. 4 (August 2012): 347. http://dx.doi.org/10.1136/ejhpharm-2012-000180.
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Pimentel, Leonardo Duarte, Claudio Horst Bruckner, Candida Elisa Manfio, Sérgio Yoshimitsu Motoike, and Hermínia Emília Prieto Martinez. "SUBSTRATE, LIME, PHOSPHORUS AND TOPDRESS FERTILIZATION IN MACAW PALM SEEDLING PRODUCTION." Revista Árvore 40, no. 2 (April 2016): 235–44. http://dx.doi.org/10.1590/0100-67622016000200006.
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ABSTRACT The macaw palm [Acrocomia aculeata (Jacq.) Lood. ex Mart] has been domesticated to subsidize biodiesel production programs in Brazil. However, little is known about the seedling production of this species. This study aimed to evaluate substrate mixtures, limestone and phosphorus rates for substrate amendment and topdressing frequency in macaw palm seedlings. Three trials were conducted in a greenhouse up to six months of nursery cultivation. Trial 1: determination of percent mineral and organic fractions of seven substrate mixtures. Trial 2: evaluation of four limerates for soil amendment versus four phosphorus rates. Trial 3: evaluation of N, K and Mg topdressing frequency. Significant differences were found in the three trials for most of the variables (plant height, leaf number, shoot dry mass, root dry mass, vigor and bulb diameter). The main results obtained were as follow: Trial1 - the best seedling growth was observed in substrates with at least 25% organic matter. Trial2 -lime rates ranging from 0.50 to 1.25 kg associated with 3 to 4 kg of single superphosphate per m3 of substrate provided the best seedling growth. Trial 3 - topdressing fertilization provided better development of seedlings regardless of frequency.
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de Vries, Ymkje Anna, Annelieke M. Roest, Erick H. Turner, and Peter de Jonge. "Hiding negative trials by pooling them: a secondary analysis of pooled-trials publication bias in FDA-registered antidepressant trials." Psychological Medicine 49, no. 12 (September 28, 2018): 2020–26. http://dx.doi.org/10.1017/s0033291718002805.
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AbstractBackgroundPrevious studies on reporting bias generally examined whether trials were published in stand-alone publications. In this study, we investigated whether pooled-trials publications constitute a specific form of reporting bias. We assessed whether negative trials were more likely to be exclusively published in pooled-trials publications than positive trials and examined the research questions, individual trial results, and conclusions presented in these articles.MethodsData from a cohort of 105 randomized controlled trials of 16 antidepressants were extracted from earlier publications and the corresponding Food and Drug Administration (FDA) reviews. A systematic literature search was conducted to identify pooled-trials publications.ResultsWe found 107 pooled-trials publications that reported results of 23 (72%) of 32 trials not published in stand-alone publications. Only two (3.8%) of 54 positive trials were published exclusively in pooled-trials publications, compared with 21 (41.1%) of 51 negative trials (p < 0.001). Thirteen (12%) of 107 publications had as primary aim to present data on the trial's primary research question (drug efficacy compared with placebo). Only four of these publications, reporting on five (22%) trials, presented individual efficacy data for the primary research question. Additionally, only five (5%) of 107 pooled-trials publications had a negative conclusion.ConclusionsCompared with positive trials, negative trials of antidepressants for depression were much more likely to be reported exclusively in pooled-trials publications. Pooled-trials publications flood the evidence base with often-redundant articles that, instead of addressing the original primary research question, present (positive) results on secondary questions. Therefore, pooled-trials publications distort the apparent risk–benefit profile of antidepressants.
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Klein, Harry, Tali Mazor, Matthew Galvin, Jason Hansel, Emily Mallaber, Pavel Trukhanov, James Provencher, James Lindsay, Michael Hassett, and Ethan Cerami. "Abstract 6455: Investigating clinical trial eligibility criteria to improve MatchMiner trial matching." Cancer Research 84, no. 6_Supplement (March 22, 2024): 6455. http://dx.doi.org/10.1158/1538-7445.am2024-6455.
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Abstract As the number of precision medicine (PM) trials and the volume of patient genomic data have grown, it has become challenging for clinicians and trial staff to identify PM trial options for patients. At Dana-Farber Cancer Institute (DFCI), we have addressed this challenge by developing our own open source institutional trial matching software called MatchMiner. MatchMiner algorithmically matches patient genomic and clinical data with PM trial eligibility data. PM trial eligibility data is manually curated into a human- and computer-readable structured format called clinical trial markup language (CTML), for trial matching with DFCI’s institutional genomic assay OncoPanel. MatchMiner has 2 main modes of clinical use: (1) patient-centric, where clinicians can search for trial matches for individual patients and (2) trial-centric, where trial staff can identify patients that match their trial’s genomic eligibility. Thus far, more than 300 DFCI patients have enrolled onto trials facilitated by MatchMiner. In its current implementation, MatchMiner uses limited clinical data (gender, age, and cancer type) to match patients to trials. Although this limited data gives clinicians a head start on assessing available trial options, incorporating more clinical data into MatchMiner would provide more precise trials options and reduce additional work to assess patient eligibility. Here, we investigated clinical trial eligibility criteria that were available for trials at DFCI with the goal of improving specificity of trial matching for MatchMiner. We attempted to answer 2 main research questions 1) what categories of clinical data comprise the eligibility criteria for precision medicine trials at DFCI and 2) which categories are most relevant for trial matching? We first investigated the clinical eligibility criteria across several PM lung cancer trials. After extracting the inclusion and exclusion criteria from the protocol documents, we found criteria could be classified into 10 distinct categories. The most common categories making up almost half of the eligibility criteria were “Prior Therapy” and “Prior or Concurrent Non-Cancerous Disease”. Within some categories, we found it appropriate to also make subcategories to make our analysis more informative such as “Prior Therapy, Surgery” or “Disease Status, CNS”. We next broadened our search to non-lung trials to see if criteria was consistent across other cancer types. We found similar proportions of clinical criteria for the non-lung trials compared to the lung trials, but did find some additional subcategories. Overall, having similar categories of criteria across trials suggests that common clinical data could be used for many different PM trials. Currently, we are investigating which categories are most relevant for trial matching and the use of AI for structuring unstructured clinical data. Citation Format: Harry Klein, Tali Mazor, Matthew Galvin, Jason Hansel, Emily Mallaber, Pavel Trukhanov, James Provencher, James Lindsay, Michael Hassett, Ethan Cerami. Investigating clinical trial eligibility criteria to improve MatchMiner trial matching [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6455.
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Kim, Daniel J., Dan Otap, Nora Ruel, Naveen Gupta, Naveed Khan, and Tanya Dorff. "NCI–Clinical Trial Accrual in a Community Network Affiliated with a Designated Cancer Center." Journal of Clinical Medicine 9, no. 6 (June 24, 2020): 1970. http://dx.doi.org/10.3390/jcm9061970.
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Most cancer care is delivered in the community, while most clinical trials exist in academic centers. We analyzed clinical trial accrual of a tertiary care cancer center and its affiliated community sites to better understand what types of trials accrued at the community sites and whether community accrual increased ethnic diversity. The institutional clinical trial database was searched for solid tumor accruals during 2018–2019. Patient’s race was abstracted, and trial’s funding source, phase, and disease type/stage were tabulated. Of 3689 accruals, 133 were at community sites, representing 26 unique trials while the main campus accrued to 93 unique trials. Community site accruals were highest for breast and colorectal cancer, but patients with less common cancers such as renal, nasopharyngeal, and gastric cancer were also accrued at community sites. Accruals occurred to randomized trials, as well as phase Ib and translational biomarker studies. Minority patients constituted 20.0% and 32.5% of community site accruals for therapeutic and non-therapeutic trials respectively, compared to 20.6% and 29.8% of main campus accruals for therapeutic and non-therapeutic trials, respectively. We conclude that community sites affiliated with an academic cancer center can accrue to a broad spectrum of clinical trials while enhancing racial diversity in participation of clinical trials. Further expansion of access to clinical trials in community sites is necessary to broaden patient access to state-of-the-art and next-generation treatment options.
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Renfro, Lindsay A., Axel M. Grothey, James Paul, Irene Floriani, Franck Bonnetain, Donna Niedzwiecki, Takeharu Yamanaka, Ioannis Souglakos, Greg Yothers, and Daniel J. Sargent. "Projecting Event-Based Analysis Dates in Clinical Trials: An Illustration Based on the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) Collaboration. Projecting Analysis Dates for the IDEA Collaboration." Forum of Clinical Oncology 5, no. 2 (December 10, 2014): 1–7. http://dx.doi.org/10.2478/fco-2014-0006.
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Abstract Purpose: Clinical trials are expensive and lengthy, where success of a given trial depends on observing a prospectively defined number of patient events required to answer the clinical question. The point at which this analysis time occurs depends on both patient accrual and primary event rates, which typically vary throughout the trial's duration. We demonstrate real-time analysis date projections using data from a collection of six clinical trials that are part of the IDEA collaboration, an international preplanned pooling of data from six trials testing the duration of adjuvant chemotherapy in stage III colon cancer, and we additionally consider the hypothetical impact of one trial's early termination of follow-up. Patients and Methods: In the absence of outcome data from IDEA, monthly accrual rates for each of the six IDEA trials were used to project subsequent trial-specific accrual, while historical data from similar Adjuvant Colon Cancer Endpoints (ACCENT) Group trials were used to construct a parametric model for IDEA's primary endpoint, disease-free survival, under the same treatment regimen. With this information and using the planned total accrual from each IDEA trial protocol, individual patient accrual and event dates were simulated and the overall IDEA interim and final analysis times projected. Projections were then compared with actual (previously undisclosed) trial-specific event totals at a recent census time for validation. The change in projected final analysis date assuming early termination of follow-up for one IDEA trial was also calculated. Results: Trial-specific predicted event totals were close to the actual number of events per trial for the recent census date at which the number of events per trial was known, with the overall IDEA projected number of events only off by eight patients. Potential early termination of follow-up by one IDEA trial was estimated to postpone the overall IDEA final analysis date by 9 months. Conclusions: Real-time projection of the final analysis time during a trial, or the overall analysis time during a trial collaborative such as IDEA, has practical implications for trial feasibility when these projections are translated into additional time and resources required.
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Foster, Henry H. "TRIAL MARRIAGES AND DIVORCE TRIALS." Family Court Review 11, no. 1 (March 15, 2005): 1–7. http://dx.doi.org/10.1111/j.174-1617.1973.tb01183.x.
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Harman, Chloë. "Putting clinical trials on trial." Nature Reviews Nephrology 5, no. 6 (June 2009): 301. http://dx.doi.org/10.1038/nrneph.2009.89.
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MIZUSHIMA, YUTAKA. "New trials of trial cases." Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 29, no. 1/2 (1998): 1–6. http://dx.doi.org/10.3999/jscpt.29.1.
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Palca, J. "Government ddI trials on trial." Science 246, no. 4935 (December 8, 1989): 1244. http://dx.doi.org/10.1126/science.2511632.
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Kahan, Brennan C., Sophie S. Hall, Elaine M. Beller, Megan Birchenall, Diana Elbourne, Edmund Juszczak, Paul Little, et al. "Consensus Statement for Protocols of Factorial Randomized Trials." JAMA Network Open 6, no. 12 (December 5, 2023): e2346121. http://dx.doi.org/10.1001/jamanetworkopen.2023.46121.
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ImportanceTrial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.ObjectiveTo develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials.Evidence ReviewThe SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist.FindingsThis SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed.Conclusions and RelevanceIn this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial’s utility and transparency.
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Sydes, Matthew R., Yolanda Barbachano, Louise Bowman, Tom Denwood, Andrew Farmer, Steph Garfield-Birkbeck, Martin Gibson, et al. "Realising the full potential of data-enabled trials in the UK: a call for action." BMJ Open 11, no. 6 (June 2021): e043906. http://dx.doi.org/10.1136/bmjopen-2020-043906.
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RationaleClinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.ApproachThe National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.ReflectionSome notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.DiscussionEHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.
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Lebensburger, Jeffrey D., Lauren Pair, Lee Hilliard, and Thomas H. Howard. "A Systematic Review Of All Interventional Sickle Cell Trials Registered At Clinicaltrials.Gov." Blood 122, no. 21 (November 15, 2013): 2990. http://dx.doi.org/10.1182/blood.v122.21.2990.2990.
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Abstract Background Clinicaltrials.gov was created in 2000 to comply with the FDA Modernization Act of 1997 and since 2007, Federal law (Section 801 of the FDA Amendments Acts) mandates registration of all applicable, prospective clinical drug trials of health outcomes. ICMJE journals also require registration of all intervention trials prior to publication. Clinicaltrials.gov offers patients and clinicians a valuable tool to identify open sickle cell disease (SCD) clinical trials by disease and results of closed trials with links to manuscripts. Objective To conduct a systematic review of all completed interventional SCD trials registered at clinicaltrials.gov and identify enrollment rates and reporting of trial results. Methods We performed a search of “sickle” in www.clinicaltrials.gov to identify every registered SCD clinical trial. (Last update: August 5, 2013). Every “closed” “interventional” registered trial was recorded in a database to include: trial name, trial identifier, start/stop date, sponsor/collaborator, primary objectives, enrollment age, expected enrollment, type of trial, and manuscripts. For trials without a manuscript in the registry, we performed a Pubmed search by keywords from the trial title, intervention, and/or PI. All manuscripts identified were reviewed to confirm trial enrollment numbers. Results Three hundred and fifty three SCD trials were registered, of which 212 (60%) were closed or completed. We performed a systematic review of 147 “interventional”, closed trials. (1983-2012). The primary sponsor or collaborator listed for these trials included an academic center (n=72, 41 unique centers registered trials), industry or pharmaceutical company (n=47), and/or NIH (n=45). Ninety trials (61%) were registered as either phase I or II, 29 (20%) registered as phase III, 8 (5%) registered as phase 4, and 20 trials did not provide a phase. Fifty two percent of trials were randomized. For trials that listed inclusion criteria for age, 41% were pediatric trials, 50% were adult, and 9% were both pediatric and adult. The most frequent outcomes of interest for these trials were pain (22%), bone marrow transplant (12%), pulmonary hypertension (7.5%), and endothelial function/dysfunction (5.5%). The reporting of trial results and manuscripts to clinicaltrials.gov was low. Nineteen of 147 (13%) trials completed the “trial results” section in clinicaltrials.gov. Twenty six trials downloaded their primary manuscript to clinicaltrials.gov despite 51 trials having manuscripts published on Pubmed. Eighty seven closed clinical trials registered on clinicaltrials.gov have not reported their trial results to clinicaltrials.gov or published their manuscripts as searched in Pubmed. Barriers to successful enrollment in SCD trials were evident in this review. Thirty two (22%) trials updated their registry to reflect “study termination” or “withdrawal”. For the 27 trials that listed the reason for this early termination/withdrawal, 17 (63%) were closed for slow enrollment. Barriers to enrollment in phase III trials were identified as 45% of phase III trials enrolled < 60% of their expected participants. The reporting of phase III trials was also low as only 16 (55%) of the registered phase III trials results have published manuscripts. Conclusion Clinicaltrials.gov can be a valuable tool for clinicians to identify SCD clinical trials, but in practice is limited by investigator reporting of trial results. SCD clinical trials that are under-enrolled or not published place subjects at risk for participation in a trial without a scientific benefit to their disease community. Research should continue to focus on identifying and overcoming barriers to enrollment in clinical trials and publication of trial results. Disclosures: No relevant conflicts of interest to declare.
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Bansal, R., R. Khan, N. Gimpaya, M. A. Scaffidi, K. Elsolh, Y. Verma, J. Li, and S. C. Grover. "A160 PREVALENCE OF OUTCOME SWITCHING AMONG PUBLISHED PHASE 3 INTERVENTIONAL TRIALS FOR INFLAMMATORY BOWEL DISEASE THERAPEUTICS." Journal of the Canadian Association of Gastroenterology 4, Supplement_1 (March 1, 2021): 167–68. http://dx.doi.org/10.1093/jcag/gwab002.158.
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Abstract Background Outcome switching is a well-described form of inconsistent reporting in randomized clinical trials (RCTs), wherein pre-specified primary and/or secondary outcomes are changed between trial registration and the publication of results without explanation. This is of particular concern, as the selective publication of results that are favorable will insert bias into the trial’s results and may cast doubt on the veracity of its findings. While it has been investigated in other disciplines, the prevalence of outcome switching has yet to be described among RCTs for inflammatory bowel disease (IBD). Aims To determine the prevalence of correctly reported pre-specified primary and secondary outcomes in published phase 3 interventional RCTs for IBD. Methods We identified all phase 3 interventional trials for IBD with published results using clinicaltrials.gov. We included all results with an associated publication that detailed the results of the trial. We excluded registrations if: only an abstract of the results was available; trial results were only published as a pooled analysis; multiple trial segments were reported collectively; or a publication of the results could not be identified through clinicaltrials.gov or a custom search. Two reviewers extracted all pre-specified primary and secondary outcomes for each trial using the clinical trial registration page that was dated before the commencement of the trial. These outcomes were compared to the outcomes reported in the corresponding journal articles. Any discrepancies were noted, and additional outcomes were extracted. Results We identified a total of 88 phase 3 interventional RCTs for IBD, of which 57 were matched to independent publications of their results. All trials pre-specified a primary outcome, and 50 (87.7%) pre-specified secondary outcomes. 10 (17.5%) of trials did not report some or all primary outcomes, and 19 (33.3%) trials had a change or alteration to the primary outcome. Of the trials that pre-specified secondary outcomes, 16 (28.1%) did not report all pre-specified secondary outcomes. 49 (86.0%) trials added 6 (IQR: 2–8) unspecified secondary outcomes on average. Conclusions Many phase 3 interventional RCTs in IBD either did not report some or all primary outcomes, or altered the primary outcome. Trials routinely reported additional outcomes that were not pre-specified and failed to note that they were added post hoc. Based on these results, we recommend improvements in the reporting of pre-specified outcomes and higher fidelity in order to maintain confidence in trial results. Funding Agencies None
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Prasad, E. Maruthi, and Shih-Ya Hung. "Current Therapies in Clinical Trials of Parkinson’s Disease: A 2021 Update." Pharmaceuticals 14, no. 8 (July 25, 2021): 717. http://dx.doi.org/10.3390/ph14080717.
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Parkinson’s disease (PD) is a progressive neurodegenerative disorder that currently has no cure, but treatments are available to improve PD symptoms and maintain quality of life. In 2020, about 10 million people worldwide were living with PD. In 1970, the United States Food and Drug Administration approved the drug levodopa as a dopamine replacement to manage PD motor symptoms; levodopa-carbidopa combination became commercialized in 1975. After over 50 years of use, levodopa is still the gold standard for PD treatment. Unfortunately, levodopa therapy-induced dyskinesia and OFF symptoms remain unresolved. Therefore, we urgently need to analyze each current clinical trial’s status and therapeutic strategy to discover new therapeutic approaches for PD treatment. We surveyed 293 registered clinical trials on ClinicalTrials.gov from 2008 to 16 June 2021. After excluded levodopa/carbidopa derivative add-on therapies, we identified 47 trials as PD treatment drugs or therapies. Among them, 19 trials are in phase I (41%), 25 trials are in phase II (53%), and 3 trials are in phase III (6%). The three phase-III trials use embryonic dopamine cell implant, 5-HT1A receptor agonist (sarizotan), and adenosine A2A receptor antagonist (caffeine). The therapeutic strategy of each trial shows 29, 5, 1, 5, 5, and 2 trials use small molecules, monoclonal antibodies, plasma therapy, cell therapy, gene therapy, and herbal extract, respectively. Additionally, we discuss the most potent drug or therapy among these trials. By systematically updating the current trial status and analyzing the therapeutic strategies, we hope this review can provide new ideas and insights for PD therapy development.
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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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Cicchetti, Americo, Domenico Addesso, Filippo Elvino Leone, Antonino Amato, Luca Angerame, Angelo D'Aversa, Mario Fraticelli, et al. "Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs." Global & Regional Health Technology Assessment 7, no. 1 (June 16, 2020): 26–32. http://dx.doi.org/10.33393/grhta.2020.709.
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Introduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials at organizational and system levels. The aim of this study was to develop and test a methodology for estimating the avoided costs deriving from the management of patients as part of a clinical trial.
Methods: Our methodology is based on the assumption that the economic value of a clinical trial derives from 1) the funding received by the experimental site from a trial’s sponsor, and from 2) the cost avoided by the experimental site with the treatment of patients within a study and not according to standard care by the experimental site.
Results: By applying the methodology to onco-hematological clinical trials conducted in two academic hospitals from 2011 to 2016, we demonstrate that savings between 2 million and 4 million euros were achieved over a five-year period. Thus, for every 1,000 euros invested by the pharmaceutical company into the clinical studies conducted at these hospitals, the hospitals saved on average 2,200 euros due to costs not incurred as a result of the trials.
Conclusions: The study has proposed and tested a methodology for estimating the economic value of clinical trials by taking into account avoided costs deriving from the treatment of patients enrolled in sponsored trials. The study has proposed a management tool for healthcare institutions to govern clinical trials.
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Nakamura, Kenichi, and Taro Shibata. "Regulatory changes after the enforcement of the new Clinical Trials Act in Japan." Japanese Journal of Clinical Oncology 50, no. 4 (February 27, 2020): 399–404. http://dx.doi.org/10.1093/jjco/hyaa028.
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Abstract Objective To describe changes in Japanese clinical trial regulations after the implementation of the Clinical Trials Act in April 2018. Methods First, how to apply multiple regulations after the enforcement of Clinical Trials Act was described. Second, the changes in the number of clinical trials in the National Cancer Center Hospital under each regulation were compared before and after the implementation of Clinical Trials Act. Third, new requirements imposed by Clinical Trials Act and their influences were discussed. Results In April 2018, Clinical Trials Act was enacted and academic clinical trials were classified into the following three categories: (i) investigator-initiated registration-directed trial under the Pharmaceuticals and Medical Devices Act; (ii) clinical trial under Clinical Trials Act; and (iii) clinical trial under the Ethical Guidelines. While 90% (205/227) of interventional studies were conducted under the Ethical Guidelines before the implementation of Clinical Trials Act in 2018, 46% (94/204) were subject to Clinical Trials Act in 2019 at the National Cancer Center Hospital. Under the Clinical Trials Act, investigators receive a scientific/ethical review by a certified review board (CRB). The identification of investigators in charge is mandated and they are required to submit the conflict of interest management plan to CRB. After the CRB review, the principal investigator must submit the trial plan to the government, and the content is uploaded to the newly established clinical trial registry site, the Japan Registry of Clinical Trials. Conclusions The enforcement of the new Clinical Trials Act was supposed to improve the reliability of academic clinical trials in Japan; however, the financial and administrative burden may reduce clinical trial activity in the years to come.
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Shah, Harshal, Akash Mishra, Michael Gouzoulis, Netanel Ben-Shalom, and Randy D'Amico. "QLTI-06. CHARACTERISTICS OF TERMINATED GLIOBLASTOMA-RELATED CLINICAL TRIALS: A REVIEW OF THE CLINICALTRIALS.GOV DATABASE." Neuro-Oncology 24, Supplement_7 (November 1, 2022): vii235. http://dx.doi.org/10.1093/neuonc/noac209.908.
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Abstract Glioblastoma multiforme (GBM) is a devastating primary central nervous system tumor. Although past clinical trials have incrementally improved prognosis overall survival remains poor, emphasizing a need for further successful clinical trials. Terminated clinical trials are an inefficient use of financial, medical, and administrative resources and fruitlessly expose patients to the risks of experimental treatments. Therefore, premature trial terminations should be minimized whenever possible. GBM-related clinical trials in particular are known to suffer several inefficiencies in study design resulting in premature termination, and a 2019 Think Tank held by the Society of Neuro-Oncology intended to address this issue, suggesting optimizing participant accrual and efficacy assessments. The primary aims of the present study are to quantify terminated and completed GBM-related clinical trials and analyze reasons for premature trial termination. Using univariate and multivariate analysis we demonstrate factors associated with greater odds of trial termination. ClinicalTrials.gov, a clinical trial registry maintained by the National Library of Medicine, was queried to identify all completed and terminated GBM-related clinical trials. Trial characteristics pertaining to study design were abstracted from reported information on ClinicalTrials.gov for all trials, and the reason for trial termination was determined for those trials that were terminated early. Univariate analysis by Pearson’s chi-square and a multivariate logistic regression were performed to identify independent predictors of early trial termination. We identified 886 completed and terminated GBM-related trials between 2003 and 2020. Of these, 175 (19.8%) were terminated prior to completion. The most common reason for termination was participant accrual difficulties, accounting for 63 (36.0%) terminated trials. Trial termination was associated with trials that reported a primary purpose of diagnosis relative to treatment (OR = 2.952, p = 0.001). The identified predictors of trial termination should be considered when designing GBM-related clinical trials to minimize the odds of early trial termination.
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Cooper, Cindy L., Amy Whitehead, Edward Pottrill, Steven A. Julious, and Stephen J. Walters. "Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials." Clinical Trials 15, no. 2 (January 23, 2018): 189–96. http://dx.doi.org/10.1177/1740774517752113.
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Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate.
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Grayling, Michael J., James MS Wason, and Adrian P. Mander. "Group sequential designs for stepped-wedge cluster randomised trials." Clinical Trials 14, no. 5 (June 27, 2017): 507–17. http://dx.doi.org/10.1177/1740774517716937.
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Background/Aims: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Methods: Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. Results: We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial’s type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. Conclusion: The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into stepped-wedge cluster randomised trials according to the needs of the particular trial.
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Abbiss, Chris R., Kevin G. Thompson, Marcin Lipski, Tim Meyer, and Sabrina Skorski. "Difference in Pacing Between Time- and Distance-Based Time Trials in Trained Cyclists." International Journal of Sports Physiology and Performance 11, no. 8 (November 2016): 1018–23. http://dx.doi.org/10.1123/ijspp.2015-0613.
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The purpose of this study was to compare the pacing profiles between distance- and duration-based trials of short and long duration. Thirteen trained cyclists completed 2 time-based (6 and 30 min) and 2 distance-based (4 and 20 km) self-paced cycling time trials. Participants were instructed to complete each trial with the highest average power output. Ratings of perceived exertion (RPEs) were measured throughout the trials. Average power output was not different between the 4-km and 6-min trials (324 ± 46 vs 325 ± 45 W; P = .96) or between the 20-km and 30-min trials (271 ± 44 vs 267 ± 38 W; P = .24). Power output was greater on commencement of the distance-based trials when short and long trials were analyzed together. Furthermore, the rate of decline in power output over the 1st 40% of the trial was greater in the 20-km trial than in the 30-min trial (P = .01) but not different between the 4-km and the 6-min trials (P = .13). RPE was greater in the 4-km trial than in the 6-min trial but not different between the 20-km and 30-min trials. These findings indicate that athletes commenced distance-based time trials at relatively higher power outputs than a similar time-based trial. Such findings may result from discrete differences in our ability to judge or predict an exercise endpoint when performing time- and distance-based trials.
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Du, Jingcheng, Qing Wang, Jingqi Wang, Prerana Ramesh, Yang Xiang, Xiaoqian Jiang, and Cui Tao. "COVID-19 trial graph: a linked graph for COVID-19 clinical trials." Journal of the American Medical Informatics Association 28, no. 9 (April 24, 2021): 1964–69. http://dx.doi.org/10.1093/jamia/ocab078.
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Abstract Objective Clinical trials are an essential part of the effort to find safe and effective prevention and treatment for COVID-19. Given the rapid growth of COVID-19 clinical trials, there is an urgent need for a better clinical trial information retrieval tool that supports searching by specifying criteria, including both eligibility criteria and structured trial information. Materials and Methods We built a linked graph for registered COVID-19 clinical trials: the COVID-19 Trial Graph, to facilitate retrieval of clinical trials. Natural language processing tools were leveraged to extract and normalize the clinical trial information from both their eligibility criteria free texts and structured information from ClinicalTrials.gov. We linked the extracted data using the COVID-19 Trial Graph and imported it to a graph database, which supports both querying and visualization. We evaluated trial graph using case queries and graph embedding. Results The graph currently (as of October 5, 2020) contains 3392 registered COVID-19 clinical trials, with 17 480 nodes and 65 236 relationships. Manual evaluation of case queries found high precision and recall scores on retrieving relevant clinical trials searching from both eligibility criteria and trial-structured information. We observed clustering in clinical trials via graph embedding, which also showed superiority over the baseline (0.870 vs 0.820) in evaluating whether a trial can complete its recruitment successfully. Conclusions The COVID-19 Trial Graph is a novel representation of clinical trials that allows diverse search queries and provides a graph-based visualization of COVID-19 clinical trials. High-dimensional vectors mapped by graph embedding for clinical trials would be potentially beneficial for many downstream applications, such as trial end recruitment status prediction and trial similarity comparison. Our methodology also is generalizable to other clinical trials.
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Praveen, Gadde, Anitha Akkaloori, Sai Lakshmi Durga Indukuri, Anusha Divvi, Mohammed Shammas, B. Jambukeshwar Kumar, Konakanchi Bharath Kumar, and Uma Devi Medicharla. "Characteristics of endodontic clinical trials registered in clinicalTrials.gov between 2000 and 2022." Endodontology 35, no. 4 (2023): 374–80. http://dx.doi.org/10.4103/endo.endo_83_23.
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ABSTRACT Aim: This study aims to examine the characteristics of endodontic clinical trials registered in the ClinicalTrials.gov database. Methods: The ClinicalTrials.gov website was searched for endodontic clinical trials that were registered between 2000 and 2022. The search term used was “endodontics.” As a result of the search strategy, 613 trials were identified. Out of which, 500 clinical trials met our inclusion criteria. For each clinical trial, information was extracted including the year of registration, location of the trial, type of trial, study design (allocation, intervention model, and masking) estimated enrollment, participants’ age, health condition/problems studied, intervention/treatment, the status of the trial, study results, phase of the trial, and source of funding. Fisher’s exact test was applied to identify the characteristics of clinical trials associated with funding. Results: The number of registered clinical trials gradually increased from 2000 to 2022. Out of 500 clinical trials, 456 were interventional, and 44 were observational. Only 18 clinical trials had secured funding. The majority of interventional trials (90.8%) are randomized, and the most common interventional model was parallel assignment (88.4%). It was observed that irreversible pulpitis was the most common condition studied (32.2%). Nonsurgical endodontic therapy was the most common intervention used in the trials (42.2%). Conclusion: The study provided an overview of endodontic clinical trials that were registered in the ClinicalTrials.gov. The findings showed that registered endodontic clinical trials have increased rapidly since 2000. The vast majority of trials took place in Africa. The majority of endodontic clinical trials followed rigorous methods in terms of allocation, intervention model, and masking. However, only a small portion of trials had secured funding. The findings also indicate the need for trial results to be made publicly available to enhance evidence-based practice in endodontics.
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Hamm, Caroline M., Krista Naccarato, Stephen Sundquist, Suzana Kovacevic, Youshaa El-Abed, and Janet Dancey. "Clinical trials navigator: Patient-centered access to clinical trials." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e14024-e14024. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e14024.
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e14024 Background: Despite recommendations from premier institutions such as NCCN that all cancer patients should be entered on clinical trials, only 3 – 5 % of adult cancer patients are enrolled on clinical trials in North America. The reason for this is multi-factorial and includes poor trial design, inappropriate endpoints, inappropriate inclusion/exclusion factors, attitudes about trial participation held by patient and/or treating physician and lack of trial availability. Methods: To address issues of trial availability, in March 2019, we initiated a novel service to help Canadian patients find clinical trial options. The service compares patient demographic and health status information provided against potential opportunities sourced using clinicaltrials.gov and Canadian clinical trials websites. A report presenting outcomes of CTN review is developed for the requesting patient or physician. An interview is provided for the self-referring patient by supporting physicians. Results: To date 96 patients have used this service. Most (94%) were stage IV or refractory/ relapsed. Smaller disease sites represented 23% of our patient population (brain, sarcoma, pancreas). Our turn-around-time from request of services to delivery of report to patient or physician improved over time and is currently 24 hours during the working week. Of those eligible, 25% of patients died before referral, the median time from referral to the CTN to the patient’s death was 109 days (3 – 188 days). Conclusions: Significant interest from both physicians and patients for this service was identified. Strategies are being developed to encourage earlier referrals to clinical trials would improve number of patients entering clinical trials as 25% of our patients. [Table: see text]
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Allan, C., A. Chapman, C. Parker, A. Boltong, and J. Millar. "Missing Evidence: Exploring Unpublished Trials in Victoria, Australia." Journal of Global Oncology 4, Supplement 2 (October 1, 2018): 96s. http://dx.doi.org/10.1200/jgo.18.28700.
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Background: Clinical trial registries were established to improve the transparency and completeness of clinical trial reporting and a number of policies have been introduced to encourage or mandate their use. While prospective trial registration has been endorsed in Australia, there is currently no legal requirement for researchers to register or communicate findings from clinical trials. There has also been, to the best of our knowledge, no analysis previously undertaken on publication rates for clinical trials performed in Australia. Aim: We aimed to determine the proportion of clinical trials that remain 'unpublished' in Victoria, Australia´s second most populous state, between 2009 and 2013. Methods: We used data reported to Cancer Council Victoria's Cancer Trials Management Scheme (CTMS) between 2009 and 2013, to identify trials that had recruited a new patient or recorded any follow-up patient activity in the specified time period. Using this data, we conducted a systematic search of ClinicalTrials.gov , the Australia and New Zealand Clinical Trials Registry (ANZCTR), PubMed and Google for records of the trial. Trial registration numbers, acronyms and scientific titles were used as primary search terms. Results were characterized by type of publication (i.e., whether it was an accredited scientific paper or other) and source location. Results: Of the trials reported to the CTMS between 2009 and 2013, 777 trials were included in this investigation; the majority (58.8%) were randomized controlled trials (RCTs). Compared with previously published findings, communication of trial results in this study was high; 70% of trials published results in an accredited scientific journal and a further 10% in alternate form, such as a conference abstract or media release. Publication rates were higher for trials with a commercial sponsor (85%) compared with trials sponsored by a cooperative group (77%). Nearly 8% of trials in this study had not been registered on an international clinical trials register. Only 39% of unregistered trials had published results. Of the registered trials, those registered on ClinicalTrials.gov were more likely to be published (86%) compared with trials listed on ANZCTR (68%). Between 2009 and 2013 , 8% of trials registered on ClinicalTrials.gov , in our data set, were terminated; 70% of these trials published results. Conclusion: Although the rate at which clinical trial findings were published in Victoria was higher in this investigation compared with equivalent overseas data, trials registered on ClinicalTrials.gov were more likely to publish results than unregistered trials or trials registered on ANZCTR. This suggests a potential need for trial registration and publication guidelines in Australia, similar to that of the United States where the requirements and procedures for submitting registration and summary result information for clinical trials on ClinicalTrials.gov have been compulsory for the last decade.
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Ludmir, Ethan B., Walker Mainwaring, Austin B. Miller, Timothy Lin, Amit Jethanandani, Andres F. Espinoza, and Clifton David Fuller. "Age disparities among cancer clinical trial participants: The role of industry sponsorship." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 11527. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.11527.
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11527 Background: Randomized controlled trials (RCTs) in oncology, which often establish the standard of care for cancer patients, do not necessarily enroll trial participants representative of the broader patient population. We sought to characterize age disparities for cancer patients enrolled on RCTs, and asked whether certain trial-related factors (such as industry sponsorship) predispose trials to larger age disparities between trial enrollees and the general population. Methods: All phase 3 RCTs in clinical oncology with results available were identified through ClinicalTrials.gov. Only randomized multi-arm trials assessing a therapeutic intervention for cancer patients were included. The scope of trials was limited to breast, colorectal, lung, and prostate disease sites. Trial participant median ages were compared to national SEER data for population median ages by disease site. Results: Three-hundred and two trials met inclusion criteria. For all trials, the trial median age was an average 6.23 years younger than the population median age (95% CI: -5.55 to -6.91 years, p < 0.001). Trials with industry sponsorship had significantly younger trial patient populations compared with non-industry-sponsored trials (mean difference from population -6.57 vs -4.48 years, p = 0.02). Younger patients were enrolled on trials evaluating targeted agents (p = 0.04), superiority-design trials (p = 0.02), and trials utilizing a surrogate primary endpoint (p = 0.03). By disease site, lung cancer trials enrolled the youngest patients relative to the population median (-8.98 years), followed by breast (-7.76 years), colorectal (-6.96 years), and prostate (+2.66 years, p < 0.001). Conclusions: Industry-funded clinical trials are associated with larger age disparities among trial participants; we believe this represents a novel finding both in clinical oncology and academic medicine more broadly. Underrepresentation of older patients on RCTs has major ramifications for the generalizability of results as well as equity of access to care; future efforts to address trial participant age disparities may focus on those trials at greatest risk for disparities based on the identified risk factors, including industry sponsorship.
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Hoderlein, Xenia, Anne M. Moseley, and Mark R. Elkins. "Citation of prior research has increased in introduction and discussion sections with time: A survey of clinical trials in physiotherapy." Clinical Trials 14, no. 4 (March 19, 2017): 372–80. http://dx.doi.org/10.1177/1740774517699821.
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Background/aims: Many clinical trials are reported without reference to the existing relevant high-quality research. This study aimed to investigate the extent to which authors of reports of clinical trials of physiotherapy interventions try to use high-quality clinical research to (1) help justify the need for the trial in the introduction and (2) help interpret the trial’s results in the discussion. Methods: Data were extracted from 221 clinical trials that were randomly selected from the Physiotherapy Evidence Database: 70 published in 2001 (10% sample) and 151 published in 2015 (10% sample). The Physiotherapy Evidence Database score (which rates methodological quality and completeness of reporting) for each trial was also downloaded. Results: Overall 41% of trial reports cited a systematic review or the results of a search for other evidence in the introduction section: 20% for 2001 and 50% for 2015 (relative risk = 2.3, 95% confidence interval = 1.5–3.8). For the discussion section, only 1 of 221 trials integrated the results of the trial into an existing meta-analysis, but citation of a relevant systematic review did increase from 17% in 2001 to 34% in 2015. There was no relationship between citation of existing research and the total Physiotherapy Evidence Database score. Conclusion: Published reports of clinical trials of physiotherapy interventions increasingly cite a systematic review or the results of a search for other evidence in the introduction, but integration with existing research in the discussion section is very rare. To encourage the use of existing research, stronger recommendations to refer to existing systematic reviews (where available) could be incorporated into reporting checklists and journal editorial guidelines.
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Byrne, David, Ciaran Prendergast, Tom Fahey, and Frank Moriarty. "Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis." BMJ Open 13, no. 5 (May 2023): e068981. http://dx.doi.org/10.1136/bmjopen-2022-068981.
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ObjectivesTo describe the characteristics of clinical study report (CSR) documents published by the European Medicines Agency (EMA), and for included pivotal trials, to quantify the timeliness of access to trial results from CSRs compared with conventional published sources.DesignCross-sectional analysis of CSR documents published by the EMA from 2016 to 2018.MethodsCSR files and medication summary information were downloaded from the EMA. Individual trials in each submission were identified using document filenames. Number and length of documents and trials were determined. For pivotal trials, trial phase, dates of EMA document publication and matched journal and registry publications were obtained.ResultsThe EMA published documents on 142 medications that were submitted for regulatory drug approval. Submissions were for initial marketing authorisations in 64.1%. There was a median of 15 (IQR 5–46) documents, 5 (IQR 2–14) trials and 9629 (IQR 2711–26,673) pages per submission, and a median of 1 (IQR 1–4) document and 336 (IQR 21–1192) pages per trial. Of all identified pivotal trials, 60.9% were phase 3 and 18.5% were phase 1. Of 119 unique submissions to the EMA, 46.2% were supported by a single pivotal trial, with 13.4% based on a single pivotal phase 1 trial. No trial registry results were identified for 26.1% trials, no journal publications for 16.7% and 13.5% of trials had neither. EMA publication was the earliest information source for 5.8% of pivotal trials, available a median 523 days (IQR 363–882 days) before the earliest publication.ConclusionsThe EMA Clinical Data website contains lengthy clinical trial documents. Almost half of submissions to the EMA were based on single pivotal trials, many of which were phase 1 trials. CSRs were the only source and a timelier source of information for many trials. Access to unpublished trial information should be open and timely to support decision-making for patients.
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Moyé, Lemuel A., and Anita Deswal. "Trials within Trials." Controlled Clinical Trials 22, no. 6 (December 2001): 605–19. http://dx.doi.org/10.1016/s0197-2456(01)00180-5.
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Naik, Anant, Emily Jean Smith, and Isabelle M. Germano. "1239 Trends in Geospatial Availability of Neuro-oncology Clinical Trials in the United States Over Two Decades." Neurosurgery 70, Supplement_1 (April 2024): 194. http://dx.doi.org/10.1227/neu.0000000000002809_1239.
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INTRODUCTION: Advances in brain tumors treatments rely on successful neuro-oncology (NO) clinical trials. To date, data on NO trials completion in the US is scarce. Understanding these factors could help improve access to and the design of future clinical trials. METHODS: NO clinical trials registered in the US were analyzed (2000-2019). Univariate and multivariate analysis were used to compare success rates among trials. Geospatial analysis was performed to determine the trial density and failure rates across different states. Trial density was estimated by the number of trials/state population. RESULTS: A total of 2,610 neuro-oncology clinical trials were registered in the US during the study period, of which 1,257 met a primary endpoint – completion or trial failure. North Dakota had the highest trial density (6.03 trials/100,000 residents), followed by South Dakota (5.83) and several Northeastern states (3.90-5.60). The change in trial failure rates did not correlate with trial density by state (p = 0.777). The states with the greatest increase in trial failure rates were Nevada (23.1%), West Virginia, Alaska, and Idaho (all three at 20.0%). Florida showed a trend towards a statistically significant increase in failure rates to 10.9% (p = 0.09). CONCLUSIONS: The results of this study highlight the variations in success rates and geographic distribution of neuro-oncology clinical trials in the United States. Factors beyond trial density may be critical to trial success. The significant geographic variations in trial density and failure rates across states emphasize the need for targeted efforts to improve access participation to trials in certain regions. Further studies aimed at identifying the factors contributing to the increase in trial failure rates are needed to develop strategies to improve trial enrollment.
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Knowles, Rachel L., Kam Pou Ha, Julia Mueller, Frances Rawle, and Rosa Parker. "Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK." BMJ Open 10, no. 2 (February 2020): e035283. http://dx.doi.org/10.1136/bmjopen-2019-035283.
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ObjectivesTo evaluate compliance by researchers with funder requirements on clinical trial transparency, including identifying key areas for improvement; to assess the completeness, accuracy and suitability for annual compliance monitoring of the data routinely collected by a research funding body.DesignDescriptive analysis of clinical trials funded between February 2011 and January 2017 against funder policy requirements.SettingPublic medical research funding body in the UK.Data sourcesRelevant clinical trials were identified from grant application details, post-award grant monitoring systems and the International Standard Randomised Controlled Trial Number (ISRCTN) registry.Main outcome measureThe proportion of all Medical Research Council (MRC)-funded clinical trials that were (a) registered in a clinical trial registry and (b) publicly reported summary results within 2 years of completion.ResultsThere were 175 grants awarded that included a clinical trial and all trials were registered in a public trials registry. Of 62 trials completed for over 24 months, 42 (68%) had publicly reported the main findings by 24 months after trial completion; 18 of these achieved this within 12 months of completion. 11 (18%) trials took >24 months to report and 9 (15%) completed trials had not yet reported findings. Five datasets were shared with other researchers.ConclusionsCompliance with the funder policy requirements on trial registration was excellent. Reporting of the main findings was achieved for most trials within 24 months of completion; however, the number of unreported trials remains a concern and should be a focus for future funder policy initiatives. Identifying trials from grant management and grant monitoring systems was challenging therefore funders should ensure investigators reliably provide trial registries with information and regularly update entries with details of trial publications and protocols.
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Wong, Karen, Rachel Phelan, Eija Kalso, Imelda Galvin, David Goldstein, Srinivasa Raja, and Ian Gilron. "Antidepressant Drugs for Prevention of Acute and Chronic Postsurgical Pain." Anesthesiology 121, no. 3 (September 1, 2014): 591–608. http://dx.doi.org/10.1097/aln.0000000000000307.
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Abstract Background: This review evaluates trials of antidepressants for acute and chronic postsurgical pain. Methods: Trials were systematically identified using predefined inclusion and exclusion criteria. Extracted data included the following: pain at rest and with movement, adverse effects, and other outcomes. Results: Fifteen studies (985 participants) of early postoperative pain evaluated amitriptyline (three trials), bicifadine (two trials), desipramine (three trials), duloxetine (one trial), fluoxetine (one trial), fluradoline (one trial), tryptophan (four trials), and venlafaxine (one trial). Three studies (565 participants) of chronic postoperative pain prevention evaluated duloxetine (one trial), escitalopram (one trial), and venlafaxine (one trial). Heterogeneity because of differences in drug, dosing regimen, outcomes, and/or surgical procedure precluded any meta-analyses. Superiority to placebo was reported in 8 of 15 trials for early pain reduction and 1 of 3 trials for chronic pain reduction. The majority of positive trials did not report sufficient data to estimate treatment effect sizes. Many studies had inadequate size, safety evaluation/reporting, procedure specificity, and movement-evoked pain assessment. Conclusions: There is currently insufficient evidence to support the clinical use of antidepressants—beyond controlled investigations—for treatment of acute, or prevention of chronic, postoperative pain. Multiple positive trials suggest the therapeutic potential of antidepressants, which need to be replicated. Other nontrial evidence suggests potential safety concerns of perioperative antidepressant use. Future studies are needed to better define the risk–benefit ratio of antidepressants in postoperative pain management. Higher-quality trials should optimize dosing, timing and duration of antidepressant treatment, trial size, patient selection, safety evaluation and reporting, procedure specificity, and assessment of movement-evoked pain relevant to postoperative functional recovery.
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Goldenberg, Joshua Z., and Cynthia A. Wenner. "A Novel N of 1 Trial Design and Proposed Utility in Complementary and Alternative Medicine Research." Journal of Evidence-Based Complementary & Alternative Medicine 17, no. 2 (March 22, 2012): 126–30. http://dx.doi.org/10.1177/2156587212437556.
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An N of 1 trial is a multiple crossover study in a single participant. N of 1trials can combine the benefits of individualized patient practice and evidence-based medicine and are amenable to complementary and alternative medicine practice and research. This article will review the basic structure of N of 1trials, discuss how they are commonly used, and review their limitations and statistical considerations. The authors also propose a novel use of the N of 1 trial in the form of mixed-methodology add-on N of 1 trials targeted to a parent trial’s responders. This design can help uncover evidence of subgroup effects in small trials, address issues surrounding the small study effect, and explore the role of interparticipant variability and random chance in the parent trial.
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Ellaway-Barnard, Christopher, Hannah Killick, Guy Peryer, Jane L. Cross, and Toby O. Smith. "The association between registration status and reported outcomes in physiotherapy randomised controlled trials." International Journal of Therapy and Rehabilitation 27, no. 3 (March 2, 2020): 1–15. http://dx.doi.org/10.12968/ijtr.2019.0023.
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Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. Trial registration was determined based on the reporting of a registration number in the primary article or by identifying trials through trial registries. Results Of the 291 trials analysed, 176 (60.5%) were registered; 115 (39.5%) were not. There was no significant association between trial registration and outcome on multivariate analyses (Odds Ratio 1.65; 95% Confidence Interval (0.92–2.96); P=0.09). Only 22% of trials were prospectively registered. Conclusions Registration status and trial outcome are not associated in randomised controlled trials of physiotherapy interventions. The rate of physiotherapy trial registration remains low.
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Hossain, M. Jahangir, Ann-Mari Svennerholm, Nils Carlin, Umberto D’Alessandro, and Thomas F. Wierzba. "A Perspective on the Strategy for Advancing ETVAX®, An Anti-ETEC Diarrheal Disease Vaccine, into a Field Efficacy Trial in Gambian Children: Rationale, Challenges, Lessons Learned, and Future Directions." Microorganisms 12, no. 1 (December 31, 2023): 90. http://dx.doi.org/10.3390/microorganisms12010090.
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For the first time in over 20 years, an Enterotoxigenic Escherichia coli (ETEC) vaccine candidate, ETVAX®, has advanced into a phase 2b field efficacy trial for children 6–18 months of age in a low-income country. ETVAX® is an inactivated whole cell vaccine that has gone through a series of clinical trials to provide a rationale for the design elements of the Phase 2b trial. This trial is now underway in The Gambia and will be a precursor to an upcoming pivotal phase 3 trial. To reach this point, numerous findings were brought together to define factors such as safe and immunogenic doses for children, and the possible benefit of a mucosal adjuvant, double mutant labile toxin (dmLT). Considering the promising but still underexplored potential of inactivated whole cells in oral vaccination, we present a perspective compiling key observations from past ETVAX® trials that informed The Gambian trial design. This report will update the trial’s status and explore future directions for ETEC vaccine trials. Our aim is to provide not only an update on the most advanced ETEC vaccine candidate but also to offer insights beneficial for the development of other much-needed oral whole-cell vaccines against enteric and other pathogens.
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Bennette, Caroline Savage, Nathan Coleman Nussbaum, Melissa D. Curtis, and Neal J. Meropol. "Using real-world cohorts to assess the generalizability and relevance of randomized clinical trials (RCTs)." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 6540. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.6540.
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6540 Background: RCTs are the gold standard for understanding the efficacy of new treatments, however, patients (pts) in RCTs often differ from those treated in the real-world. Further, selecting a standard of care (SOC) arm is challenging as treatment options may evolve during the course of a RCT. Our objective was to assess the generalizability and relevance of RCTs supporting recent FDA approvals of anticancer therapies. Methods: RCTs were identified that supported FDA approvals of anticancer therapies (1/1/2016 - 4/30/2018). Relevant pts were selected from the Flatiron Health longitudinal, EHR-derived database, where available. Two metrics were calculated: 1) a trial’s pt generalizability score (% of real-world pts receiving treatment consistent with the control arm therapy for the relevant indication who actually met the trial's eligibility criteria) and 2) a trial’s SOC relevance score (% of real-world pts with the relevant indication and meeting the trial's eligibility criteria who actually received treatment consistent with the control arm therapy). All analyses excluded real-world pts treated after the relevant trial’s enrollment ended. Results: 14 RCTs across 5 cancer types (metastatic breast, advanced non-small cell lung cancer, metastatic renal cell carcinoma, multiple myeloma, and advanced urothelial) were included. There was wide variation in the SOC relevance and pt generalizability scores. The median pt generalizability score was 63% (range 35% - 88%), indicating that most real-world pts would have met the RCT eligibility criteria. The median SOC relevance score was 37% (range 15% - 74%), indicating that most RCT control arms did not reflect the way trial-eligible real-world pts in the US were actually treated. Conclusions: There is great variability across recent RCTs in terms of pt generalizability and relevance of SOC arms. Real-world data can be used to inform selection of control arms, predict impact of inclusion/exclusion criteria, and also assess the generalizability of the results of completed trials. Incorporating real-world data in planning and interpretation of prospective clinical trials could improve accrual and enhance relevance of RCT outcomes.
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Jones, Marcus, Marin Harbur, and Ken J. Moore. "Automating Uniformity Trials to Optimize Precision of Agronomic Field Trials." Agronomy 11, no. 6 (June 21, 2021): 1254. http://dx.doi.org/10.3390/agronomy11061254.
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Plot size has an important impact on variation among plots in agronomic field trials, but is rarely considered during the design process. Uniformity trials can inform a researcher about underlying variance, but are seldom used due to their laborious nature. The objective of this research was to describe variation in maize field trials among field plots of varying size and develop a tool to optimize field-trial design using uniformity-trial statistics. Six uniformity trials were conducted in 2015–2016 in conjunction with Iowa State University and WinField United. All six uniformity trials exhibited a negative asymptotic relationship between variance and plot size. Variance per unit area was reduced over 50% with plots 41.8 m2 in size and over 75% when using a plot size >111.5 m2 compared to a 13.9 m2 plot. Plot shape within a fixed plot size did not influence variance. The data illustrated fewer replicates were needed as plot size increased, since larger plots reduced variability. Use of a Shiny web application is demonstrated that allows a researcher to upload a yield map and consider uniformity-trial statistics to inform plot size and replicate decisions.
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Waligóra-Dziwak, Katarzyna, Aleksandra Dańczak-Pazdrowska, and Dorota Jenerowicz. "A Comprehensive Review of Biologics in Phase III and IV Clinical Trials for Atopic Dermatitis." Journal of Clinical Medicine 13, no. 14 (July 9, 2024): 4001. http://dx.doi.org/10.3390/jcm13144001.
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Atopic dermatitis (AD) is a skin condition characterized by significant challenges and a substantial deterioration in the life quality for affected patients. The therapeutic landscape for AD has witnessed a transformative shift with the emergence of biologic therapies. Our focus centers on biologics currently undergoing phase III and IV clinical trials, deeming them to hold the highest potential for significant clinical relevance. To identify biologic drugs under development in phase III and IV clinical trials, we searched ClinicalTrials.gov. Additional relevant trials were identified through JapicCTI/ Japan Registry of Clinical Trials (jRCT) with a citation search. A search in MEDLINE and EMBASE was performed. There have been 76 clinical trials identified concerning biologic drugs: dupilumab (34 trials), lebrikizumab (14 trials), tralokinumab (10 trials), rocatinlimab (7 trials), amlitelimab (2 trials), nemolizumab (6 trials), MG-K10 (1 trial), CM310 (1 trial), 611 (1 trial). A search in MEDLINE revealed 132 articles concerning phase III and IV clinical trials for AD treatment. A total of 39 articles concerned biologic drugs covering 23 clinical trials. A search in EMBASE revealed 268 relevant articles, allowing us to identify results of an additional six clinical trials. The safety and efficacy of these biologics are comprehensively addressed in this review. This comprehensive review aims to explore the current landscape of biologic therapies for AD, delving into the latest research findings, clinical trial outcomes, and the diverse mechanisms of action employed by these novel interventions.
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Weinberg, Jeffrey. "Clinical Trials in Progress: ROADS Trial." ONCOLOGY, no. 3508 (August 2021): 495. http://dx.doi.org/10.46883/onc.2021.3508.0495.
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Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with GammaTile for Treatment of Newly Diagnosed Metastatic Brain Tumors (ROADS; NCT04365374).
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Dean, Rachel S. "Veterinary clinical trials are on trial." Veterinary Record 181, no. 8 (August 18, 2017): 193–94. http://dx.doi.org/10.1136/vr.j3867.
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Rokhsefat, Sana, Deanna E. Morra, Martin Offringa, Lisa M. Askie, and Lauren E. Kelly. "Trial registration in pediatric surgery trials." Journal of Pediatric Surgery 53, no. 7 (July 2018): 1273–79. http://dx.doi.org/10.1016/j.jpedsurg.2017.10.049.
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Curtis, John J., and Bruce Kaplan. "Transplant Immunosuppressive Drug Trials on Trial." American Journal of Transplantation 4, no. 5 (May 2004): 671–72. http://dx.doi.org/10.1111/j.1600-6143.2004.00474.x.
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