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Clinical Trials: Journal of the Society for Clinical Trials

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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
#1
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
#2
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
#3
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/28905640/neurobiological-mechanisms-of-exercise-and-psychotherapy-in-depression-the-speed-study-rationale-design-and-methodological-issues
#4
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
#5
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
#6
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
#7
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
#8
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
https://www.readbyqxmd.com/read/28825324/university-of-pennsylvania-ninth-annual-conference-on-statistical-issues-in-clinical-trials-where-are-we-with-adaptive-clinical-trial-designs-morning-panel-discussion
#9
Valerie Durkalski, Steven Joffe, Rick Chappell
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28819997/comparisons-of-cancer-staging-systems-should-be-based-on-overall-performance-in-the-population
#10
Kathleen F Kerr, Michael LeBlanc, Holly Janes
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28819983/an-evaluation-of-the-effectiveness-of-a-risk-based-monitoring-approach-implemented-with-clinical-trials-involving-implantable-cardiac-medical-devices
#11
Christopher A Diani, Angie Rock, Phil Moll
Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28797179/the-optimal-design-of-stepped-wedge-trials-with-equal-allocation-to-sequences-and-a-comparison-to-other-trial-designs
#12
Jennifer A Thompson, Katherine Fielding, James Hargreaves, Andrew Copas
Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28795844/sample-size-adjustment-designs-with-time-to-event-outcomes-a-caution
#13
Boris Freidlin, Edward L Korn
BACKGROUND: Sample size adjustment designs, which allow increasing the study sample size based on interim analysis of outcome data from a randomized clinical trial, have been increasingly promoted in the biostatistical literature. Although it is recognized that group sequential designs can be at least as efficient as sample size adjustment designs, many authors argue that a key advantage of these designs is their flexibility; interim sample size adjustment decisions can incorporate information and business interests external to the trial...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28795584/use-of-an-android-phone-application-for-automated-text-messages-in-international-settings-a-case-study-in-an-hiv-clinical-trial-in-st-petersburg-russia
#14
Leah S Forman, Gregory J Patts, Sharon M Coleman, Elena Blokhina, John Lu, Tatiana Yaroslavtseva, Natalia Gnatienko, Evgeny Krupitsky, Jeffrey H Samet, Christine E Chaisson
BACKGROUND/AIMS: Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. METHODS: To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28795578/evaluating-biomarkers-for-prognostic-enrichment-of-clinical-trials
#15
Kathleen F Kerr, Jeremy Roth, Kehao Zhu, Heather Thiessen-Philbrook, Allison Meisner, Francis Perry Wilson, Steven Coca, Chirag R Parikh
BACKGROUND/AIMS: A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. METHODS: We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28786330/risk-adapted-monitoring-is-not-inferior-to-extensive-on-site-monitoring-results-of-the-adamon-cluster-randomised-study
#16
Oana Brosteanu, Gabriele Schwarz, Peggy Houben, Ursula Paulus, Anke Strenge-Hesse, Ulrike Zettelmeyer, Anja Schneider, Dirk Hasenclever
Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28783972/motivations-enrollment-decisions-and-socio-demographic-characteristics-of-healthy-volunteers-in-phase-1-research
#17
Christine Grady, Gabriella Bedarida, Ninet Sinaii, Mark Anthony Gregorio, Ezekiel J Emanuel
BACKGROUND/AIM: Phase 1 trials with healthy volunteers are an integral step in drug development. Commentators worry about the possible exploitation of healthy volunteers because they are assumed to be disadvantaged, marginalized, and inappropriately influenced by the offer of money for research for which they do not appreciate the inherent risks. Yet there are limited data to support or refute these concerns. This study aims to describe the socio-demographic characteristics, motivations, and enrollment decision-making of a large cohort of healthy volunteers...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776422/isotonic-designs-for-phase-i-trials-in-partially-ordered-groups
#18
Mark Conaway
BACKGROUND/AIMS: Dose-finding trials can be conducted such that patients are first stratified into multiple risk groups before doses are allocated. The risk groups are often completely ordered in that, for a fixed dose, the probability of toxicity is monotonically increasing across groups. In some trials, the groups are only partially ordered. For example, one of several groups in a trial may be known to have the least risk of toxicity for a given dose, but the ordering of the risk among the remaining groups may not be known...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776417/university-of-pennsylvania-ninth-annual-conference-on-statistical-issues-in-clinical-trials-where-are-we-with-adaptive-clinical-trial-designs-afternoon-panel-discussion
#19
Jason T Connor, Angela DeMichele, Janet Wittes
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776412/commentary-on-freidlin-and-korn
#20
Cyrus Mehta
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
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