Journal articles on the topic 'Trial'
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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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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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Veld, Diana de. "Triac Trial wordt vervolgd." Endocrinologie 14, no. 2 (June 2021): 22–24. http://dx.doi.org/10.24078/endo.2021.6.127302.
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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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Lotfizadeh, Amin D., Meghan A. Herron, and Alan Poling. "Frequency of learning trials presented during trial-by-trial versus first-trial data recording." Behavior Analysis: Research and Practice 20, no. 1 (February 2020): 71–80. http://dx.doi.org/10.1037/bar0000164.
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Phuong, Tran Vinh, Nguyen Anh Tuan, Nguyen Duy Thuan, Ngo Thi Huong Giang, Tran Nguyen Ngoc, Nguyen Duy Quynh Tram, and Nguyen Quang Linh. "Effects of protein levels of commercial diets on the growth performance and survival rate of rabbitfish (Siganus guttatus) at the nursing stage." Journal of Experimental Biology and Agricultural Sciences 10, no. 5 (October 31, 2022): 1115–20. http://dx.doi.org/10.18006/2022.10(5).1115.1120.
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This study aimed to determine the effect of a commercial diet's protein level on the fry-to-fingerling stage. Thirty days-old fries having the initial length and weight of 18.25 ± 0.15 mm fish-1 and 0.036 ± 0.50 g fish-1 respectively have been used in this study. Diet having three protein levels i.e. 30% (trial 1 as control), 35% (trial 2), 40% (trial 3), and 45% (trial 4), respectively, have been used to evaluate the effect of protein, and each trial has been repeated three times. During the study, stocking density was allocated to 1000 fish per composite tank with a volume of 1 m3. After 30 days of rearing, the weight of fingerlings in trial 1 reached up to 1.50 ± 0.02 g fish-1 and it was recorded as 1.52 ± 0.01g for trial 2, these two were lower than that of trials 3 and 4, where fingerling weight was reported 1.69 ± 0.01 and 1.58g fish-1 respectively and obtained the best weight compared to others. The length of fingerlings at the end of the experimental period was also changed in different trials and it was recorded 47.12; 46.92; 50.97; and 48.89 mm fish-1 for trail 1, 2, 3, and 4 respectively, among the tested combinations lower fingerlings length was recorded for trial 2 (35% CP), but it is not significantly different for trial 1 and 2 and a significant difference (P < 0.05) was reported for trail 2, 3, and 4. The survival rate of fingerlings ranged from 67.27 to 72.33%. Meanwhile, the herd distribution coefficient variation (CVW) in the treatment using 40% protein (trial 3) was the highest at 72.33% (p < 0.05). The results of the study can be concluded that the level of protein has a significant effect on the various growth parameters of fingerlings.
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McKeown, Kate, Emma Richards, Jessica Richardson, and Andrea Tales. "The Trails Making Test. Does a Single Trial Reflect Performance Capability?" OBM Neurobiology 05, no. 02 (January 8, 2021): 1. http://dx.doi.org/10.21926/obm.neurobiol.2102100.
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Information processing speed (Reaction time, RT) to a single administration of the Trails A and Trails B components of the Trail Making Test (TMT) is used in the assessment of brain and behavioural functional integrity across the lifespan in both clinical and research contexts. Although the clinical utility of such single trial-related and thus rapidly gained results, is recognised, it is possible that its administration as a single trial only, precludes its ability to provide a more in-depth and thus relevant representation of functional integrity per se, and it does not allow a range of ability to be examined. Because outcome from a single trial can be susceptible to the influence of spurious and extraneous effects we examined how, within a single testing session, RT varied with respect to the administration of four trials of both Trails A and B of the TMT, and how the effects may be associated with anxiety and self-consciousness. We examined how RT varied with respect to the administration of four trials of the Trail making test and compared the performance over each of these trials with that of the first trial. Between the third and fourth trial, questionnaires on anxiety and self-consciousness were administered. This paradigm was tested with fifty five younger adults (age range eighteen - thirty years). Our results indicated that repeating both Trails A and B of the TMT, administering the tests over four trials, revealed a significantly disproportionately slowed information processing speed (RT) to the first compared to consecutive trials, with the effect greatest for the more difficult or resource-demanding Trails B test. There were no significant correlations between change in information processing speed and anxiety or self-consciousness. The first of the four trials represents the only trial typically performed in the clinical application of this test. Our finding that the time to complete one single trial can be significantly slower compared to the response to additional trials, indicates that an individuals’ information processing speed can appear much slower than their actual ability. Such findings can be expected to be of particular relevance to the future use of this test clinically when an individual’s performance is measured and judged with respect to possible diagnosis, and in future research when group-level TMT performance is compared between younger and older adults for example.
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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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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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Vleugels, Lore W. E., Stephan P. Swinnen, and Robert M. Hardwick. "Skill acquisition is enhanced by reducing trial-to-trial repetition." Journal of Neurophysiology 123, no. 4 (April 1, 2020): 1460–71. http://dx.doi.org/10.1152/jn.00741.2019.
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Developing approaches to improve motor skill learning is of considerable interest across multiple disciplines. Previous research has typically shown that repeating the same action on consecutive trials enhances short-term performance but has detrimental effects on longer term skill acquisition. However, most prior research has contrasted the effects of repetition only at the block level; in the current study we examined the effects of repeating individual trials embedded in a larger randomized block, a feature that is often overlooked when random trial orders are generated in learning tasks. With 4 days of practice, a “Minimal Repeats” group, who rarely experienced repeating stimuli on consecutive trials during training, improved to a greater extent than a “Frequent Repeats” group, who were frequently presented with repeating stimuli on consecutive trials during training. Our results extend the previous finding of the beneficial effects of random compared with blocked practice on performance, showing that reduced trial-to-trial repetition during training is favorable with regard to skill learning. This research highlights that limiting the number of repeats on consecutive trials is a simple behavioral manipulation that can enhance the process of skill learning. Data/analysis code and Supplemental Material are available at https://osf.io/p3278/ . NEW & NOTEWORTHY Numerous studies have shown that performing different subtasks across consecutive blocks of trials enhances learning. We examined whether the same effect would occur on a trial-to-trial level. Our Minimal Repeats group, who primarily responded to different stimuli on consecutive trials, learned more than our Frequent Repeats group, who frequently responded to the same stimulus on consecutive trials. This shows that minimizing trial-to-trial repetition is a simple and easily applicable manipulation that can enhance learning.
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Stensland, Kristian, Samuel Kaffenberger, David Canes, Matthew Galsky, Ted Skolarus, and Alireza Moinzadeh. "Assessing Genitourinary Cancer Clinical Trial Accrual Sufficiency Using Archived Trial Data." JCO Clinical Cancer Informatics, no. 4 (September 2020): 614–22. http://dx.doi.org/10.1200/cci.20.00031.
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PURPOSE Clinical trials often fail to reach their anticipated end points, most frequently because of poor accrual. Prior studies have analyzed trial termination, but it has not been easy to assess accrual estimates using international databases such as ClinicalTrials.gov because of limitations in accessing accrual information. Specifically, it is not easy to extract both anticipated and actual accrual of clinical trials. We designed a new algorithmic approach to extracting trial accrual data from ClinicalTrials.gov and used it to estimate the sufficiency of patient accrual onto genitourinary (GU) cancer trials. METHODS We queried ClinicalTrials.gov for completed/terminated phase II and III clinical trials for prostate, bladder, kidney, testicular, and ureteral cancers registered after 2007. We extracted trial characteristics from available XML files. We then used a Python algorithm to access prior trial registrations on the ClinicalTrials.gov archive site and extract both anticipated and actual accrual numbers. We then compared the actual accrual of each trial to its anticipated accrual and defined sufficient accrual as 85% of anticipated accrual. RESULTS The algorithm was 100% accurate compared with hand extraction in a small validation subset. A total of 925 trials were included, of which 840 (91%) had both anticipated and actual accrual. Only 418 (50%) trials had sufficient accrual (≥ 85% of anticipated). Considering only trials marked as successfully completed, 395/597 (66%) reached sufficient accrual. CONCLUSION GU cancer trials often do not meet their anticipated accrual goals. New approaches to trial conduct are direly needed. Our reproducible and scalable approach to extracting accrual information can be applied to analysis of ClinicalTrials.gov in future analyses in the hope of improving the efficiency of the clinical trials enterprise.
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Prithvi, K. G., and M. Punnagai. "Media Trial - an Overview." International Journal of Trend in Scientific Research and Development Volume-3, Issue-2 (February 28, 2019): 116–19. http://dx.doi.org/10.31142/ijtsrd20295.
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Kamijo, Keita, and Yuji Takeda. "Physical Activity and Trial-by-Trial Adjustments of Response Conflict." Journal of Sport and Exercise Psychology 35, no. 4 (August 2013): 398–407. http://dx.doi.org/10.1123/jsep.35.4.398.
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The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-bytrial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.
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Rao, Amol, Kevin Miller, Chanh Trung Huynh, Rachel Luedtke, Mary Alice Anderson, Melissa Harris, Michael Johnstone, et al. "The Tempus TIME trial portal and clinical trial enrollment." Journal of Clinical Oncology 41, no. 16_suppl (June 1, 2023): 1583. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.1583.
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1583 Background: The TIME Trial Program is a research network that screens > 1 million patients daily via EMR integrations and NGS testing through an automated trial matching platform and human review. There are enormous complexities following patients longitudinally as their clinical status changes while accurately matching them with hundreds of studies. The TIME Trials Portal, which stores both clinical trial documents and patient status updates, allows for real-time communication between the TIME team and Clinical Sites. Methods: After both an automated and nursing review, eligible trial patients are uploaded into the TIME Trials Portal. This database tracks the patient’s name, date of birth, biomarkers, clinical status, trial matches, free text comments, and upcoming physician, radiology, and laboratory appointments. To protect Personal Health Information, each Clinical Site can only view their own patients. Patient status is classified as Needs Review, Monitoring, Enrolled, Inactive. Each update is time-stamped and tracked. Enrolled patients have the trial name, consent date, and other pertinent information documented. Results: The data from 2020 to 2022 includes 71 TIME Sites. Over this period, 6,816 patients were added to the TIME Trials Portal for an average of 219 per month. Of these, 1,891 patients were no longer eligible due to worsening performance status, trial closure, death, and other causes. The TIME team provided 8,643 patient updates compared to 7,442 Clinical Site updates. Clinical Sites spent 1,231.7 hours using the TIME Therapies Portal resulting in 623 total consents. Data from 2022 alone, demonstrated that 30 (42.3%) Clinical Sites with EMR integrations were responsible for 4,491 (76.3% of the total) patient updates translating into 288 (82.1%) of all consents. Also in 2022, of the 27 (38%) Clinical Sites that updated their patient’s status > 50 times consented 291 (82.9% of the total) patients. Conclusions: By 2022, the TIME Trials Portal was averaging approximately 400 new patients monthly resulting in a 13.1X increase in patients added from the program’s inception. Clinical Sites updated the patient status over 7,400 times spending over 1,200 hours using the TIME Trials Portal. The highest-performing Clinical Sites, which enrolled approximately 80% of the total patients, included those with EMR integrations and/or > 50 patient updates yearly. The TIME Trials Portal enabled patient tracking and communication to facilitate clinical trial enrollment.[Table: see text]
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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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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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Altman, Douglas G. "Within Trial Variation—A False Trail?" Journal of Clinical Epidemiology 51, no. 4 (April 1998): 301–3. http://dx.doi.org/10.1016/s0895-4356(98)00005-5.
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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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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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Park, Hyungkwan. "The Principle of the Judge immobility and Public Trial Base Principle." Korean Association of Criminal Procedure Law 15, no. 4 (December 31, 2023): 97–129. http://dx.doi.org/10.34222/kdps.2023.15.4.97.
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Under the Korean Supreme Court Personnel Order, a regular transfer of judges to different jurisdictions is effected at preset terms. This practice is highly unusual and although the practice was undoubtedly a measure in securing a more sound legal system, troubling side effects have occurred. Two prominent examples include the undermining of the right of a citizen's right to a speedy trial and a weakening of the public trial principle. Changing judges during a trial is akin to changing an umpire during a sporting event.
The practice is not only inefficient but places an unfair burden on the parties to reestablish their case anew before a new judge. This is an example of why most countries ensure the principle of judge immobility wherein judges are not moved to new jurisdictions nor promoted without consent. The public trial base principle maintains that a judge's decision in rendering a guilty or not guilty verdict should be formed mainly in the open courts. This principle includes the principle of direct evidence investigation, concentration of trial procedure, and public trials among others. In the past, Korea criminal procedure had depended largely on the principle of protocol trials, wherein a decision was largely based on the investigating agent's protocols. In an effort to correct the possible biased nature of the practice, the public trial base principle has hence been increasingly emphasized.
When there is a change in the presiding judge, it is extremely difficult to ascertain the reasoning formed through the former trial procedure in rendering a guilty or not guilty decision. Even if the evidence is reinvestigated according to the renewal procedure of the trial, there are limits to what can clearly be reestablished. As a result, frequent changes in the trial bench are tantamount to practically undermining the public trial base principle.
To ensure a citizen's right to a fair and speedy trial and successfully establish the public trial base principle, the principle of judge immobility must be guaranteed. This should be effected not merely as a judicial personnel policy but as a principle in securing the constitutional right of the victim as well as the defendant and in keeping with due process. There are two options to introduce the principle of judge immobility: a comprehensive approach or a gradual introduction. Should the latter be adopted, it should first be introduced at the district court level. Further, in facilitating the preliminary trail procedure and the public trial base principle, the introduction of a vice-judge appointing system would be highly beneficial.
There has been an increasing delay in the trial procedure of major trials. It is high time to guarantee the principle of immobility of judges to ensure the right of citizens to receive fair and speedy trials and to further solidify the public trial base principle in our legal systems.
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Renjith, Vishnu, Renjulal Yesodharan, and Anice George. "Registration of Clinical Trials: What Nurse Researchers Need to Know." Nursing Journal of India CIX, no. 03 (2018): 135–36. http://dx.doi.org/10.48029/nji.2018.cix303.
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Clinical trials registry is an official platform for registering a clinical trial. Trial registration refers to the publication of a set of information regarding the methods, conduct, and administration of clinical trials. Any researcher who plans to conduct a trial involving human participants can register the trial in the registry. Researchers can register their trials at any trial registry which conforms to standards of World Health Organisation (WHO). Clinical trial registration fulfills ethical obligations to participants and the research community. Registering a trial at the registry is considered as an ethical step towards the enhanced visibility, greater transparency, and accountability in undertaking clinical research.
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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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Blair, McClellan G. "Trial on Trial." Science News 158, no. 1 (July 1, 2000): 3. http://dx.doi.org/10.2307/3981441.
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Mickenautsch, Steffen. "Is the Deductive Falsification Approach a Better Basis for Clinical Trial Appraisal?" Reviews on Recent Clinical Trials 14, no. 3 (August 21, 2019): 224–28. http://dx.doi.org/10.2174/1574887114666190313170400.
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Background: Inductive reasoning relies on an infinite regress without sufficient factual basis and verification is at any time vulnerable to single contrary observation. Thus, appraisal based on inductive verification, as applied in current clinical trial appraisal scales, checklists or grading systems, cannot prove or justify trial validity. Discussion: Trial appraisal based on deductive falsification can identify invalid trials and give evidence for the recommendation to exclude these from clinical decision-making. Such appraisal remains agnostic towards corroborated trials that pass all appraisal criteria. The results of corroborated trials cannot be considered more robust than falsified trials since nothing within a particular set of complied trial criteria can give certainty for trial compliance with any other appraisal criterion in future. A corroborated trial may or may not reflect therapeutic truth and may thus be the basis for clinical guidance, pending results of any future trial re-appraisal. Conclusion: Trial grading following appraisal based on deductive falsification should be binary (0 = Invalid or 1 = Unclear) and single component scores should be multiplied. Appraisal criteria for the judgment of trial characteristics require a clear rationale, quantification of such rationale and empirical evidence concerning the effect of trial characteristics on trial results.
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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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Moffitt, K., R. D. Marsh, and C. Hudson. "The case for proactive, collaborative data-updating in a statewide cancer clinical trial matching service." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 6570. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6570.
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6570 Background Florida has the second highest cancer incidence of any state in the United States. To address Florida's growing cancer burden and the need for increased clinical trial participation, Florida Cancer Trials (FCT) launched a web-based and phone-based Clinical Trial Matching Service for the State of Florida on November 1, 2004 (operated by EmergingMed). After 2 years of monthly outreach to 96 trial sites, the FCT wanted to assess the outcome and ongoing need for intensive, grass-roots data verification activities in light of other publicly available cancer clinical trial databases. Methods On 10/23/06, FCT staff extracted all trials containing at least one Florida trial site from the PDQ and ClinicalTrials.gov (CT.gov) database. The same extraction was produced from the TrialCheck database on 11/10/06. Each database was compared to the list of active cancer clinical trials in the FCT/EmergingMed database on the same day. Every trial-site listed in the PDQ/CT.gov database, but missing from the FCT/EmergingMed database, was contacted by FCT staff to confirm the accuracy of each trial/site combination. Results PDQ/CT.gov contained 547 trials listed with Florida trial sites on 10/23/06 (the FCT/EmergingMed database contained 526 trials on the same day). On 11/10/06, the TrialCheck database listed 528 trials with Florida trial sites (the FCT/EmergingMed database contained 513 verified trials on the same day). The PDQ/CT.gov database was missing 25% of Florida's open trials, while the TrialCheck database was missing 36% of Florida's open trials. Moreover, 19% of PDQ/CT.gov's trial listings and 25% of TrialCheck's listings for Florida were erroneous. Conclusions With 25%–36% of Florida's trials missing from public databases, and 19%–25% of their current listings being false listings for Florida, the FCT continues to conclude that a grass-roots, monthly data verification schedule is necessary to maintain a cancer clinical trial database that is suitable for use in referring patients and physicians to Florida's cancer clinical trial sites. No significant financial relationships to disclose.
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Sabo, Samantha, Naomi Lee, Grant Sears, Dulce J. Jiménez, Marissa Tutt, Jeffersson Santos, Omar Gomez, et al. "Community Health Representatives as Trusted Sources for Increasing Representation of American Indian Communities in Clinical Research." International Journal of Environmental Research and Public Health 20, no. 5 (March 1, 2023): 4391. http://dx.doi.org/10.3390/ijerph20054391.
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Indigenous and American Indian Alaskan Native (AI/AN) community members are systematically underrepresented in clinical trial research. This paper focuses on exploratory steps to partner with Native Nations of Arizona to engage Community Health Representatives (CHR) as a trusted source for building COVID-19 clinical trial research, including vaccine trials awareness. CHRs are frontline public health workers who apply a unique understanding of the experience, language, and culture of the population served. This workforce has entered the spotlight as essential to the prevention and control of COVID-19. Methods: Three Tribal CHR programs were engaged to develop and refine culturally centered educational materials and a pre-post survey using a consensus-based decision-making approach. CHRs used these materials in brief education sessions during regular client home visits and community events. Results: At 30 days post CHR intervention, participants (N = 165) demonstrated significantly increased awareness about and ability to enroll in COVID-19 treatment and vaccine trials. Participants also described a significant increase in trust in researchers, decreased perceived barriers related to cost for participation in a clinical trial, and improved belief that participation in a COVID-19 clinical trial for treatment was considered a benefit to American Indian and Alaskan Native people. Conclusion: CHRs as trusted sources of information, coupled with culturally centered education materials designed by CHRs for CHR clients, demonstrated a promising approach to improved awareness of clinical trial research generally and COVID-19 trials specifically among Indigenous and American Indian community members of Arizona.
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Jain, Neha, Kathleen F. Mittendorf, Marilyn Holt, Michele Lenoue-Newton, Ian Maurer, Clinton Miller, Matthew Stachowiak, et al. "The My Cancer Genome clinical trial data model and trial curation workflow." Journal of the American Medical Informatics Association 27, no. 7 (June 1, 2020): 1057–66. http://dx.doi.org/10.1093/jamia/ocaa066.
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Abstract Objective As clinical trials evolve in complexity, clinical trial data models that can capture relevant trial data in meaningful, structured annotations and computable forms are needed to support accrual. Material and Methods We have developed a clinical trial information model, curation information system, and a standard operating procedure for consistent and accurate annotation of cancer clinical trials. Clinical trial documents are pulled into the curation system from publicly available sources. Using a web-based interface, a curator creates structured assertions related to disease-biomarker eligibility criteria, therapeutic context, and treatment cohorts by leveraging our data model features. These structured assertions are published on the My Cancer Genome (MCG) website. Results To date, over 5000 oncology trials have been manually curated. All trial assertion data are available for public view on the MCG website. Querying our structured knowledge base, we performed a landscape analysis to assess the top diseases, biomarker alterations, and drugs featured across all cancer trials. Discussion Beyond curating commonly captured elements, such as disease and biomarker eligibility criteria, we have expanded our model to support the curation of trial interventions and therapeutic context (ie, neoadjuvant, metastatic, etc.), and the respective biomarker-disease treatment cohorts. To the best of our knowledge, this is the first effort to capture these fields in a structured format. Conclusion This paper makes a significant contribution to the field of biomedical informatics and knowledge dissemination for precision oncology via the MCG website. Key words knowledge representation, My Cancer Genome, precision oncology, knowledge curation, cancer informatics, clinical trial data model
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Tion, M. A., and P. C. Njoku. "Assessing calcium availability from limestone sources through bone and blood status of chickens." Nigerian Journal of Animal Production 36, no. 1 (January 1, 2021): 85–95. http://dx.doi.org/10.51791/njap.v36i1.1396.
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Calcium (Cu) availability from limestone (procured from different cement factories) was assessed through bone and blood status of chickens using the completely randomized design. Five hundred and twenty five (525) straight run broiler chicks that were 28 days Of age (trial l), four hundred and twenty (420) broiler finishers that were 56 days of age (trial 2), and 210 layers that had been laying for six months (trial 3) were used in the study. Six limestone dietary treatments and a control accounted for the seven diets that were assessed Twelve birds per treatment and 4 per replicate that had their weights close to the mean of the pen were selected in the broiler trials (trials I and 2) and three birds per pen and nine per diet were selected in the layer trial (trial 3) for bone and blood samples analysis. Bone samples were analyzed for bone weight, bone length, ash weight, percentage ash, Ca and phosphorus contents of ash and blood samples were analyzed for plasma Ca and alkaline phosphates activity. Results showed similar influence of sources on bone weight, bone length, ash weight and percentage ash. Ca and P contents of ash were significantly (P<0.05) affected by limestone sources but generally. Limestone sources produced mean values that were equal to or than the control diet in the starter phase (trail 1). In the finisher phase (trial 2), only Ca content of ashy varied significantly where Jakura source produced the least mean value. The layer trial (trial 3) also produced mean values that were significant (P <0.05) for Ca content of ash with the Sokoto source producing the least mean value. Plasma Ca and alkaline phosphates enzyme activity attained published values for chickens. It was concluded based on the information from this study that the (h from tested limestone sources was generally available for chicken production.
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Pyke, K. E., and F. Jazuli. "Impact of repeated increases in shear stress via reactive hyperemia and handgrip exercise: no evidence of systematic changes in brachial artery FMD." American Journal of Physiology-Heart and Circulatory Physiology 300, no. 3 (March 2011): H1078—H1089. http://dx.doi.org/10.1152/ajpheart.00736.2010.
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Reactive hyperemia (RH) creates an uncontrolled, transient increase in brachial artery (BA) shear stress (SS) for flow-mediated dilation (FMD) assessment. In contrast, handgrip exercise (HGEX) can create similar, sustained SS increases over repeated trials. The purpose of this study was to examine the impact of repeated SS elevation via RH or HGEX and the relationship between RH and HGEX %FMD. BA diameter and blood velocity were assessed with echo and Doppler ultrasound in 20 healthy subjects. Visit A consisted of four 6-min HGEX trials (HGEX trials 1–4) at the intensity required to achieve a shear rate (SR = mean blood velocity/BA diameter; an estimate of SS) of 65 s−1. Visit B consisted of four RH trials (RH trials 1–4). The RH SR area under the curve (AUC) was higher in trial 1 versus trial 3 and trial 4 ( P = 0.019 and 0.047). The HGEX mean SR was similar across trials (mean SR = 66.1 ± 5.8 s−1, P = 0.152). There were no differences in %FMD across trials or tests (RH trial 1: 6.9 ± 3.5%, trial 2: 6.9 ± 2.3%, trial 3: 7.1 ± 3.5%, and trial 4: 7.0 ± 2.8%; HGEX trial 1: 7.3 ± 3.6%, trial 2: 7.0 ± 3.6%, trial 3: 6.5 ± 3.5%, and trial 4: 6.8 ± 2.9%, P = 0.913). No relationship between subject's RH %FMD and HGEX %FMD was detected ( r2 = 0.12, P = 0.137). However, with response normalization, a relationship emerged (RH %FMD/SR AUC vs. HGEX %FMD/mean SR, r2 = 0.44, P = 0.002). In conclusion, with repeat trials, there were no systematic changes in RH or HGEX %FMD. The relationship between normalized RH and HGEX %FMD suggests that endothelial responses to different SS profiles provide related information regarding endothelial function.
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Murphy, Megan, and Daniel Merenstein. "Grassroots Campaign Trail Methods to Recruit for Clinical Trials: Recruitment Lessons Learned from Trail to Trial." Clinical Medicine Insights: Pediatrics 5 (January 2011): CMPed.S6488. http://dx.doi.org/10.4137/cmped.s6488.
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Background Literature reviews have identified recruitment as the single most challenging obstacle in conducting pediatric trials. This paper describes a paradigm shift in recruitment design, developed from experience with grassroots campaigns through the DRINK study (Decreasing the Rates of Illness in Kids). The objective of this study was to explain a new method for recruiting in clinical trials based on lessons learned from grassroots political campaigning. Methods and Findings The study described is a randomized controlled trial of 638 3–6 year olds from the Washington, DC Area. The design involved a comparison between new recruiting approaches modeled after grassroots campaigns and traditional techniques. Traditional techniques for the purpose of this paper are defined by the use of physician referral, mass media such as radio and television advertisements, along with posters in public places like the subway. Grassroots approaches alternatively developed and utilized community contacts and employed targeted small market media community. The main outcome measures were the percentage of budget used and the number of eligible participants recruited. Conclusions The results showed that the grassroots recruitment approach saved 30% of the budget, recruited 638 kids in 4 months and retained over 90% for the 90 day trial. New techniques need further exploration as community studies are stressed.
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Schwarze, Steve, Julie Clauer, Manju George, Lindsey Musick, Nancy Seybold, and Adrian Terek. "Empowering colorectal cancer patients and caregivers through clinical trials education in COLONTOWN." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): e24129-e24129. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e24129.
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e24129 Background: Clinical trials are increasingly part of the continuum of care for colorectal cancer patients, particularly those with metastatic disease. Yet most patients have limited knowledge about clinical trials, and many struggle to navigate the myriad barriers to enrollment. To bridge this gap, PALTOWN supports a broad array of activities in its COLONTOWN online community to help patients and caregivers interested in pursuing clinical trials. The function and impact of these activities is examined here. Methods: A comprehensive inventory of all clinical trial-related activity was conducted across three main sources: 1) resources and activity in COLONTOWN’s nine clinical trial-focused groups; 2) clinical trial materials posted in COLONTOWN UNIVERSITY, an online disease education center; and 3) patient feedback on clinical trial programming. Results: The MSS and MSI-High clinical trial groups in COLONTOWN serve more than 2,200 members, and more than 1,000 members are served by mutation- and location-specific trial groups. These groups have helped at least 187 members enroll in a clinical trial between 2019 and 2022. Among 10 trial-related activities, a majority (6/10) focused on sharing biomedical information, including : 1) patient-friendly descriptions of new trials; 2) explanations of trial results; 3) abstracts, articles, and videos from professional outlets such as ASCO Daily Post and OncLive; 4) patient-created resources on clinical trial basics in COLONTOWN UNIVERSITY; 5) “Doc Talks” by prominent CRC oncologists; and 6) patient advocates serving as information liaisons between patients and NCI Task Forces. A smaller number of activities (3/10) focused on psycho-social support from peers, including 1) accounts of patient experiences while seeking and participating in trials; 2) strategy discussions about how and when to pursue trials; and 3) “Alanna Project” database of members on a trial. COLONTOWN’s Clinical Trial Workshop (1/10) offers a novel approach to integrating biomedical education with psycho-social support via a four-week, peer-led clinical trial navigation program. Assessment of the cognitive and behavioral outcomes of the workshop demonstrate improvements in all four dimensions of health literacy: the ability to access, understand, appraise, and apply relevant information in the search for clinical trials. Conclusions: COLONTOWN's clinical trial programming offers comprehensive clinical trial education to patients and caregivers that leads to enrollment in trials. By embedding that education within a supportive community of peers, it enhances patients' capacity to collaborate with health care professionals in making informed decisions about clinical trials.
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Bednall, David H. B., Harmen Oppewal, Krongjit Laochumnanvanit, and Cuc Nguyen. "A trial engagement? Innovative free and other service trials." Journal of Services Marketing 32, no. 1 (February 12, 2018): 46–56. http://dx.doi.org/10.1108/jsm-12-2016-0420.
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Purpose This paper aims to discover how consumers process an innovative set of systematically varied service trial offers and how this affects their learning and interaction as precursors to customer engagement. Design/methodology/approach The research uses experiments that manipulate pricing, type of service and delivery method. A repeated-measures design was used with a sample of 396 participants. Findings Free (as opposed to cost or full price) service trials were more likely to be accepted, with perceived truthfulness of the trial offer and perceived obligation mediating the relationship. Credence service trials generate higher levels of perceived obligation than experience service trial offers, while personal services are more likely to lead to trial adoption. Research limitations/implications The research can be extended to well-recognized brands and further mixed service contexts. Practical implications Trial offers of new services are best targeted at buyers who are in the likely buyer group. The trial offer may accelerate time to purchase and relieve perceived risks. The trials of credence services need further signals of quality in the trial itself for consumers to adopt the full service. With personal service trials, skeptical consumers need assurance as to what will happen after the trial experience. Free trials may actually devalue a service, threatening engagement. Originality/value Uniquely, service trial offers are systematically manipulated using experience versus credence and personal versus impersonal trials to determine their effect on acceptance of the trial offer and the full service. Additionally, the study compares free, cost price and full price trial offers.
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Wear, Sandra M., Paul G. Richardson, Carolyn Revta, Ravi Vij, Mark Fiala, Sagar Lonial, Alaina R. Mitchell, et al. "The Multiple Myeloma Research Consortium (MMRC): Accelerated Start up and Accrual Metrics Speeds Drug Development." Blood 118, no. 21 (November 18, 2011): 1024. http://dx.doi.org/10.1182/blood.v118.21.1024.1024.
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Abstract Abstract 1024 Background: The MMRC is a non-profit, disease-focused consortium founded in 2004. Sixteen North American member institutions with expertise in multiple myeloma (MM) work collaboratively with the MMRC Inc. (Norwalk, CT) and numerous pharmaceutical partners to speed development of new treatment options to MM patients. In December 2007, MMRC Inc. implemented business solutions to address barriers to rapid activation of phase I-II trials and established benchmarks for initiating and conducting these studies. In December 2010, we reported significantly faster trial start up and accrual data from previous years1,2. Today, we update and expand on MMRC performance data and analysis of progress. Methods: Twenty-five (25) trials conducted within the Consortium from May 2006 to July 2011 had sufficient start up trial data for review. FPFD was defined as the time from the member institutions' receipt of the final protocol (FP) from the trial sponsor, to the time the first patient was dosed on the trial at any participating MMRC member institution. With respect to enrollment, pre-study enrollment commitment (EC) established between MMRC and the study sponsor was defined as the total number of subjects committed to receive at least one dose of study drug across all participating MMRC centers on a trial; baseline enrollment timeline (BET) was prospectively defined as the target time period to attain EC. Results: Mean time to FPFD in the recent group of trials (RG; n=18; Sept 08-Jul 11) held steady at 131 calendar days from receipt of FP as compared to 181 days for the early group of trials (EG; n=7; Jun06-Sept08) representing a 28% reduction in time to FPFD. More importantly, there was a 20% decrease in time to FPFD by all participating MMRC centers on any MMRC trial from 189 days in the RG compared to 236 days in the EG representing an important achievement especially in the Phase I/II arena. MMRC trial accrual data was available for 17/25 trials (2 EG trials were missing data and 6 RG trials continue enrolling). The pre-study mean MMRC EC was 44 subjects per trial (n=19 trials; 849 patients); the mean actual MMRC enrollment was 49 subjects per trial (n=19; 935 patients through July 11) representing a 10% over enrollment versus committed enrollment. A total of 17/19 evaluable trials (89%) met their EC; 12/19 trials met EC within BET (71%) of which 8/12 trials (67%) reached EC 34% faster than their BET (representing a mean reduction of 4.5 months). The overall pre-study mean BET for 19 trials was 13.6 months. MMRC's actual mean enrollment timeline was 12.8 months for the group of 17 evaluable trials representing improvement over the original BET by a mean of 10%. Discussion: MMRC's acceleration of clinical trials provides physicians and patients with rapid access to novel compounds; industry with data for important drug development decisions; and academic institutions with more trials of high scientific interest. Even so, our data uncovered opportunities for improvement. The submission time from receipt of the final protocol from the trial sponsor to Scientific Review Committee (SRC) took an average 30 calendar days across all trials. A reduction to half this time could make a difference to patients and therefore warrants further exploration. Conclusion: Today, drug development in multiple myeloma is fast-paced and highly competitive. MMRC's frequent review of trial metrics provides valuable insight to continually speed answers to physicians, patients and industry. Disclosures: Richardson: Multiple Myeloma Research Consortium: Annual grant in support Clinical Trial Project Management. Vij:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Lonial:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Siegel:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Jakubowiak:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Reece:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Jagannath:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Hofmeister:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Stewart:Multiple Myeloma Research Consortium: Annual Grant in support of clinical trial Project Management. Wolf:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Krishnan:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Zimmerman:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Kumar:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Roy:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Fay:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Anderson:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management.
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Mirza, Reza D., and Gordon H. Guyatt. "A Randomized Clinical Trial of n-of-1 Trials—Tribulations of a Trial." JAMA Internal Medicine 178, no. 10 (October 1, 2018): 1378. http://dx.doi.org/10.1001/jamainternmed.2018.3979.
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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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Nipp, Ryan D., Kessely Hong, and Electra D. Paskett. "Overcoming Barriers to Clinical Trial Enrollment." American Society of Clinical Oncology Educational Book, no. 39 (May 2019): 105–14. http://dx.doi.org/10.1200/edbk_243729.
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Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.
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Tamboli, S. S., A. B. Surwade, K. J. Mahale, K. B. Khairnar, K. B. Avhad, A. V. Avhad, A. G. Chavan, et al. "Clinical Trials: Essential Stage in Development of Drug." Journal of Drug Delivery and Therapeutics 12, no. 4-S (August 15, 2022): 210–13. http://dx.doi.org/10.22270/jddt.v12i4-s.5621.
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This article gives an idea about the clinical trials and way its importance in the development of the vaccine. The different phases which are involved in clinical trials like phase I, phase II, phase III, and phase IV. Each phase role in the development of vaccines and how clinical trials play an important role in the treatment of various diseases. The role of a clinical trial is to help society and the entire medical community by contributing to the research and development of new drugs concerning their safety and efficacy.
Keywords: Preclinical trials, phase I trial, phase II trial, phase III trial, phase IV trial
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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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Raza, M. Zulfiqar, Hanne Bruhn, and Katie Gillies. "Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions." BMJ Open 10, no. 1 (January 2020): e035730. http://dx.doi.org/10.1136/bmjopen-2019-035730.
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ObjectiveTo determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.DesignAudit of records.SettingPhase III clinical trials registered on the UK’s research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.Main outcome measuresProportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.ResultsOut of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.ConclusionsReported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.
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Biswas, Abhishek, C. V. Shendkar, Bikas K. Arya, PK Lenka, Ratnesh Kumar, and M. Mahadevappa. "Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development." Indian Journal of Physical Medicine and Rehabilitation 27, no. 1 (2016): 2–9. http://dx.doi.org/10.5005/ijopmr-27-1-2.
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Abstract Objective This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry- India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed. Design and Methods The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI. Conclusions Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.
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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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Moorcraft, Sing Yu, Cheryl Marriott, Clare Peckitt, David Cunningham, Ian Chau, Naureen Starling, David Watkins, Jervoise Andreyev, and Sheela Rao. "A prospective patient (pt) survey on clinical trials." Journal of Clinical Oncology 33, no. 3_suppl (January 20, 2015): 707. http://dx.doi.org/10.1200/jco.2015.33.3_suppl.707.
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707 Background: Recruitment to clinical trials can be challenging. We conducted a patient survey to improve our understanding of pts’ views and experiences of clinical trials and what aspects could be improved. Methods: Pts who had been approached about participation in any clinical trial in the Gastrointestinal (GI) and Lymphoma Unit at the Royal Marsden were prospectively invited to complete a questionnaire about their views and experiences of cancer research. Results: Between August 2013 and July 2014, 276 pts (90% GI, 10% lymphoma) received 298 clinical trial pt information sheets (PIS) and were asked to complete a questionnaire. 263 respondents (Res) consented to a trial and 249 of these (95%) completed the questionnaire (65 for clinical trials of an investigational medicinal product (CTIMP), 156 for non-CTIMPs and 28 for molecular pre-screening trials). 25 Res declined a trial and 10 of these completed the questionnaire. Of the 249 Res who consented to a trial, 96% were glad to be approached about clinical trials. 90% of Res felt the PIS was easy to understand and rated the verbal explanation of the trial as excellent/good. 10 Res who declined a trial felt the verbal explanation was excellent/good and that the PIS was easy to understand. The mean total PIS length (including sub-studies) was 17 pages (range 3-50 pages). 9% of Res who consented to a trial felt the PIS was too long. Regarding CTIMP trials, 48-50% of Res would have liked more information on trial drugs and any additional research procedures, 28-30% were neutral and 20-24% did not want more information. 75% of Res would consider participating in studies requiring a research biopsy and 78% would donate their tissue for genetic research. 79% of pre-screening trial Res, 66% of non-CTIMP trial Res and 54% of CTIMP trial Res would have been willing to consent to the trial on the day they received the PIS. 75% of Res (including 89% of CTIMP Res) believed pts should be told trial results, even if results are not available for many years. Conclusions: The majority of pts are willing to be approached regarding clinical trials. A high proportion of pts would consider studies involving research biopsies. New strategies for tailoring additional trial information according to the patient and informing pts of trial results should be explored.
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Fisher, Jill A., Lisa McManus, Julianne M. Kalbaugh, and Rebecca L. Walker. "Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?" Clinical Trials 18, no. 4 (May 2, 2021): 477–87. http://dx.doi.org/10.1177/17407745211011069.
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Background/aims Financial compensation for research participation is a major focus of ethical concern regarding human subject recruitment. Phase I trials are sometimes considered to be a lucrative source of income for healthy volunteers, encouraging some people to become “professional guinea pigs.” Yet, little is known about how much these clinical trials actually pay and how much healthy volunteers earn from them. Methods As part of a mixed-methods, longitudinal study of healthy volunteers, we required participants to complete clinical trial diaries, or surveys that captured detailed information about screening and enrollment in Phase I trials. Over a 3-year period, participants provided information online or via telephone about each clinical trial for which they screened (e.g. the clinic name, the study’s therapeutic area, the length of the trial, the number of nights spent in the clinic, and the study compensation), and whether they qualified for trial inclusion. Clinical trial diaries generated data about whether participants continued to screen for and enroll in clinical trials and how much money they earned from their participation. Results 131 participants routinely completed clinical trial diaries or confirmed that they had not screened for any new clinical trials. Together, these participants screened for 1001 clinical trials at 73 research facilities during a 3-year period. Overall, the median clinical trial compensation was US$3070 (range = US$150–US$13,000). Participants seeking new healthy volunteer trials tended to screen for three studies per year, participate in one or two studies, and earn roughly US$4000 annually. Participants who were unemployed earned the most income from clinical trials compared to those with full-time or part-time jobs, and those individuals whom we label “occupational” participants because of their persistent pursuit of clinical trials earned more than people who screened occasionally. Notably, the median annual trial compensation was well below US$10,000 for all employment groups, and most occupational healthy volunteers also earned less than US$10,000 each year. The 10% of participants who earned the most had a median annual income of US$18,885 from clinical trials, and there was significant volatility in these individuals’ earnings from year to year. Conclusion Despite the perception that Phase I enrollment can generate significant earnings, it was exceedingly rare for anyone in this study to make more than US$20,000 in a single year, and unusual to earn even between US$10,000 and US$20,000. From an ethics perspective, individual trials might appear to unduly induce enrollment by offering significant sums of money, but given our findings, the larger problem for low-income participants may be the unrealistic perception that clinical trials alone could be a way of earning a living.