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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/29235369/academic-chartered-data-safety-committees-versus-industry-sponsored-data-safety-committees-the-need-for-different-recommendations
#1
David J Weber, David J Couper, Ross J Simpson
No abstract text is available yet for this article.
December 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29224380/ethics-and-practice-of-trials-within-cohorts-an-emerging-pragmatic-trial-design
#2
Scott Yh Kim, James Flory, Clare Relton
BACKGROUND: With increasing emphasis on pragmatic trials, new randomized clinical trial designs are being proposed to enhance the "real world" nature of the data generated. We describe one such design, appropriate for unmasked pragmatic clinical trials in which the control arm receives usual care, called "Trials within Cohorts" that is increasingly used in various countries because of its efficiency in recruitment, advantages in reducing subject burden, and ability to better mimic real-world consent processes...
December 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29224379/just-in-time-consent-the-ethical-case-for-an-alternative-to-traditional-informed-consent-in-randomized-trials-comparing-an-experimental-intervention-with-usual-care
#3
Andrew J Vickers, Danny A Young-Afat, Behfar Ehdaie, Scott Yh Kim
Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention...
December 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29214850/rejoinder
#4
Andrew Vickers, Danny Young-Afat, Behfar Ehdaie, Scott Yh Kim
No abstract text is available yet for this article.
December 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29124956/a-systematic-review-and-development-of-a-classification-framework-for-factors-associated-with-missing-patient-reported-outcome-data
#5
Michael J Palmer, Rebecca Mercieca-Bebber, Madeleine King, Melanie Calvert, Harriet Richardson, Michael Brundage
BACKGROUND/AIMS: Missing patient-reported outcome data can lead to biased results, to loss of power to detect between-treatment differences, and to research waste. Awareness of factors may help researchers reduce missing patient-reported outcome data through study design and trial processes. The aim was to construct a Classification Framework of factors associated with missing patient-reported outcome data in the context of comparative studies. The first step in this process was informed by a systematic review...
November 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29121787/factors-associated-with-reporting-results-for-pulmonary-clinical-trials-in-clinicaltrials-gov
#6
Isaretta L Riley, L Ebony Boulware, Jie-Lena Sun, Karen Chiswell, Loretta G Que, Monica Kraft, Jamie L Todd, Scott M Palmer, Monique L Anderson
Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013...
November 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29039683/a-systematic-review-of-federal-drug-administration-docket-for-community-consultation-and-public-disclosure-in-exception-from-informed-consent-trials
#7
Adrianne N Haggins, Deneil Harney, Sara Scott, Robert Silbergleit
BACKGROUND: Exception from informed consent imposes community consultation and public disclosure requirements on clinical investigation in critically ill and injured patients. In 2011, the Food and Drug Administration instructed sponsors to submit publically disclosed information to the Food and Drug Administration Docket, but to date there has been no comprehensive analysis of available data. We summarized the community consultation and public disclosure practices of exception from informed consent trials published on the Food and Drug Administration Docket in order to better understand the breadth of common practices that exists among acute care clinical research...
October 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29035083/multiplicity-adjusted-semiparametric-benefiting-subgroup-identification-in-clinical-trials
#8
Patrick M Schnell, Peter Müller, Qi Tang, Bradley P Carlin
Background A recent focus in the health sciences has been the development of personalized medicine, which includes determining the population for which a given treatment is effective. Due to limited data, identifying the true benefiting population is a challenging task. To tackle this difficulty, the credible subgroups approach provides a pair of bounding subgroups for the true benefiting subgroup, constructed so that one is contained by the benefiting subgroup while the other contains the benefiting subgroup with high probability...
October 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28982261/time-to-institutional-review-board-approval-with-local-versus-central-review-in-a-multicenter-pragmatic-trial
#9
Mark D Neuman, Lakisha J Gaskins, Tracy Ziolek
BACKGROUND/AIMS: Central institutional review board (IRB) review will be required for National Institutes of Health-funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial...
October 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29198178/zero-tolerance-for-acronyms
#10
Colin B Begg
No abstract text is available yet for this article.
December 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28982263/a-simulation-study-of-outcome-adaptive-randomization-in-multi-arm-clinical-trials
#11
J Kyle Wathen, Peter F Thall
Randomizing patients among treatments with equal probabilities in clinical trials is the established method to obtain unbiased comparisons. In recent years, motivated by ethical considerations, many authors have proposed outcome adaptive randomization, wherein the randomization probabilities are unbalanced, based on interim data, to favor treatment arms having more favorable outcomes. While there has been substantial controversy regarding the merits and flaws of adaptive versus equal randomization, there has not yet been a systematic simulation study in the multi-arm setting...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28982262/adaptive-designs-the-swiss-army-knife-among-clinical-trial-designs
#12
Frank Bretz, Paul Gallo, Willi Maurer
There has been considerable progress in the development and implementation of adaptive designs over the past 30 years. A major driver for this class of novel designs is the possibility to increase the information value of clinical trial data to enable better decisions, leading to more efficient drug development processes and improved late-stage success rates. In the first part of this article, we review the development of adaptive designs from different perspectives. We trace back key historical papers, report on landmark adaptive design clinical trials, review major cross-industry collaborations, and highlight key regulatory guidance documents...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28693389/primary-care-physicians-attitudes-and-beliefs-about-cancer-clinical-trials
#13
Carma L Bylund, Elisa S Weiss, Margo Michaels, Shilpa Patel, Thomas A D'Agostino, Emily B Peterson, Maria Christina Binz-Scharf, Natasha Blakeney, M Diane McKee
BACKGROUND/AIMS: Cancer clinical trials give patients access to state-of-the-art treatments and facilitate the translation of findings into mainstream clinical care. However, patients from racial and ethnic minority groups remain underrepresented in clinical trials. Primary care physicians are a trusted source of information for patients, yet their role in decision-making about cancer treatment and referrals to trial participation has received little attention. The aim of this study was to determine physicians' knowledge, attitudes, and beliefs about cancer clinical trials, their experience with trials, and their interest in appropriate training about trials...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28653550/group-sequential-designs-for-stepped-wedge-cluster-randomised-trials
#14
Michael J Grayling, James Ms Wason, Adrian P Mander
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...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28649874/a-web-application-for-evaluating-phase-i-methods-using-a-non-parametric-optimal-benchmark
#15
Nolan A Wages, Nikole Varhegyi
BACKGROUND/AIMS: In evaluating the performance of Phase I dose-finding designs, simulation studies are typically conducted to assess how often a method correctly selects the true maximum tolerated dose under a set of assumed dose-toxicity curves. A necessary component of the evaluation process is to have some concept for how well a design can possibly perform. The notion of an upper bound on the accuracy of maximum tolerated dose selection is often omitted from the simulation study, and the aim of this work is to provide researchers with accessible software to quickly evaluate the operating characteristics of Phase I methods using a benchmark...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28905640/neurobiological-mechanisms-of-exercise-and-psychotherapy-in-depression-the-speed-study-rationale-design-and-methodological-issues
#16
Stephan Heinzel, Michael A Rapp, Thomas Fydrich, Andreas Ströhle, Christina Terán, Gunnar Kallies, Melanie Schwefel, Andreas Heissel
BACKGROUND/AIMS: Even though cognitive behavioral therapy has become a relatively effective treatment for major depressive disorder and cognitive behavioral therapy-related changes of dysfunctional neural activations were shown in recent studies, remission rates still remain at an insufficient level. Therefore, the implementation of effective augmentation strategies is needed. In recent meta-analyses, exercise therapy (especially endurance exercise) was reported to be an effective intervention in major depressive disorder...
September 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28879782/characteristics-and-trends-of-clinical-trials-funded-by-the-national-institutes-of-health-between-2005-and-2015
#17
Gillian K Gresham, Stephan Ehrhardt, Jill L Meinert, Lawrence J Appel, Curtis L Meinert
Background The National Institutes of Health is one of the largest biomedical research agencies in the world. Clinical trials are an important component of National Institutes of Health research efforts. Given the recent updates in National Institutes of Health trial reporting requirements, more information regarding the current state of National Institutes of Health-funded clinical trials is warranted. The objective of this analysis was to describe characteristics and trends of clinical trials funded by the National Institutes of Health over time and by Institutes and Centers of the National Institutes of Health...
September 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28862483/prep-chicago-a-randomized-controlled-peer-change-agent-intervention-to-promote-the-adoption-of-pre-exposure-prophylaxis-for-hiv-prevention-among-young-black-men-who-have-sex-with-men
#18
Lindsay E Young, Phil Schumm, Leigh Alon, Alida Bouris, Matthew Ferreira, Brandon Hill, Aditya S Khanna, Thomas W Valente, John A Schneider
BACKGROUND/AIMS: Advances in biomedical prevention strategies such as pre-exposure prophylaxis (PrEP) represent a new opportunity for reducing HIV incidence among young Black men who have sex with men, for whom the number of new HIV infections continues to rise. However, studies have documented low rates of PrEP uptake in this community. Research suggests that the peer networks of young Black men who have sex with men play important roles in their sexual health decisions. PrEP Chicago is a randomized controlled trial network intervention designed to increase PrEP uptake among young Black men who have sex with men living in Chicago...
September 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29025270/design-of-a-randomized-clinical-trial-of-a-colorectal-cancer-screening-decision-aid-to-promote-appropriate-screening-in-community-dwelling-older-adults
#19
Christine E Kistler, Carol Golin, Carolyn Morris, Alexandra F Dalton, Russell P Harris, Rowena Dolor, Renée M Ferrari, Noel T Brewer, Carmen L Lewis
BACKGROUND: Appropriate colorectal cancer screening in older adults should be aligned with the likelihood of net benefit. In general, patient decision aids improve knowledge and values clarity, but in older adults, they may also help patients identify their individual likelihood of benefit and foster individualized decision-making. We report on the design of a randomized clinical trial to understand the effects of a patient decision aid on appropriate colorectal cancer screening. This report includes a description of the baseline characteristics of participants...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28830236/testing-many-treatments-within-a-single-protocol-over-10%C3%A2-years-at-mrc-clinical-trials-unit-at-ucl-multi-arm-multi-stage-platform-umbrella-and-basket-protocols
#20
Mahesh Kb Parmar, Fay H Cafferty, Matthew R Sydes, Babak Choodari-Oskooei, Ruth E Langley, Louise Brown, Patrick Pj Phillips, Melissa R Spears, Sam Rowley, Richard Kaplan, Nicholas D James, Timothy Maughan, Nicholas Paton, Patrick J Royston
BACKGROUND: There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone - often we find that a new treatment is no better than the current standard. PURPOSE AND METHODS: Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this paper we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
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