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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/28178849/adaptive-designs-from-a-data-safety-monitoring-board-perspective-some-controversies-and-some-case-studies
#1
Bruce W Turnbull
This article describes vignettes concerning interactions with Data Safety Monitoring Boards during the design and monitoring of some clinical trials with an adaptive design. Most reflect personal experiences by the author.
February 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28166647/building-trust-and-diversity-in-patient-centered-oncology-clinical-trials-an-integrated-model
#2
Thelma C Hurd, Charles D Kaplan, Elise D Cook, Janice A Chilton, Jay S Lytton, Ernest T Hawk, Lovell A Jones
BACKGROUND/AIMS: Trust is the cornerstone of clinical trial recruitment and retention. Efforts to decrease barriers and increase clinical trial participation among diverse populations have yielded modest results. There is an urgent need to better understand the complex interactions between trust and clinical trial participation. The process of trust-building has been a focus of intense research in the business community. Yet, little has been published about trust in oncology clinical trials or the process of building trust in clinical trials...
February 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28142249/commentary-on-fleming-et-al-data-monitoring-committee-evidence-base-needed
#3
Michael Terrin
No abstract text is available yet for this article.
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135839/delivering-successful-randomized-controlled-trials-in-surgery-methods-to-optimize-collaboration-and-study-design
#4
Natalie S Blencowe, Jonathan A Cook, Thomas Pinkney, Chris Rogers, Barnaby C Reeves, Jane M Blazeby
Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions)...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135837/rejoinder
#5
Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas Lg Andersson, Marc A Pfeffer, Susan S Ellenberg
No abstract text is available yet for this article.
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135830/a-randomized-trial-of-heart-failure-disease-management-in-skilled-nursing-facilities-snf-connect-lessons-learned
#6
Andrea Daddato, Heidi L Wald, Carolyn Horney, Diane L Fairclough, Erin C Leister, Marilyn Coors, Warren H Capell, Rebecca S Boxer
BACKGROUND/AIMS: Conducting clinical trials in skilled nursing facilities is particularly challenging. This manuscript describes facility and patient recruitment challenges and solutions for clinical research in skilled nursing facilities. METHODS: Lessons learned from the SNF Connect Trial, a randomized trial of a heart failure disease management versus usual care for patients with heart failure receiving post-acute care in skilled nursing facilities, are discussed...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135827/a-conceptual-model-for-the-development-process-of-confirmatory-adaptive-clinical-trials-within-an-emergency-research-network
#7
Samkeliso C Mawocha, Michael D Fetters, Laurie J Legocki, Timothy C Guetterman, Shirley Frederiksen, William G Barsan, Roger J Lewis, Donald A Berry, William J Meurer
BACKGROUND: Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. METHODS: We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135804/the-interaction-between-equipoise-and-logistics-in-clinical-trials-a-case-study
#8
Meredith G Warshaw, Vincent J Carey, Elizabeth J McFarland, Liza Dawson, Elaine Abrams, Ann Melvin, Lee Fairlie, Hans Spiegel, Jonathan Jay, Allison L Agwu
INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28124579/using-a-network-based-approach-and-targeted-maximum-likelihood-estimation-to-evaluate-the-effect-of-adding-pre-exposure-prophylaxis-to-an-ongoing-test-and-treat-trial
#9
Laura Balzer, Patrick Staples, Jukka-Pekka Onnela, Victor DeGruttola
BACKGROUND: Several cluster-randomized trials are underway to investigate the implementation and effectiveness of a universal test-and-treat strategy on the HIV epidemic in sub-Saharan Africa. We consider nesting studies of pre-exposure prophylaxis within these trials. Pre-exposure prophylaxis is a general strategy where high-risk HIV- persons take antiretrovirals daily to reduce their risk of infection from exposure to HIV. We address how to target pre-exposure prophylaxis to high-risk groups and how to maximize power to detect the individual and combined effects of universal test-and-treat and pre-exposure prophylaxis strategies...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28068834/design-considerations-of-a-randomized-controlled-trial-of-sedation-level-during-hip-fracture-repair-surgery-a-strategy-to-reduce-the-incidence-of-postoperative-delirium-in-elderly-patients
#10
Tianjing Li, L Susan Wieland, Esther Oh, Karin J Neufeld, Nae-Yuh Wang, Kay Dickersin, Frederick E Sieber
Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28068789/pragmatic-trial-of-video-education-in-nursing-homes-the-design-and-rationale-for-a-pragmatic-cluster-randomized-trial-in-the-nursing-home-setting
#11
Vincent Mor, Angelo E Volandes, Roee Gutman, Constantine Gatsonis, Susan L Mitchell
Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28064525/healthy-children-strong-families-2-a-randomized-controlled-trial-of-a-healthy-lifestyle-intervention-for-american-indian-families-designed-using-community-based-approaches
#12
Emily J Tomayko, Ronald J Prince, Kate A Cronin, Tassy Parker, Kyungmann Kim, Vernon M Grant, Judith N Sheche, Alexandra K Adams
Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28064524/an-embedded-randomised-controlled-trial-of-a-teaser-campaign-to-optimise-recruitment-in-primary-care
#13
Hopin Lee, Markus Hübscher, G Lorimer Moseley, Steven J Kamper, Adrian C Traeger, Ian W Skinner, Christopher M Williams, James H McAuley
BACKGROUND: Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. METHODS: Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28059578/a-bayesian-meta-analytic-approach-for-safety-signal-detection-in-randomized-clinical-trials
#14
Motoi Odani, Satoru Fukimbara, Tosiya Sato
BACKGROUND/AIM: Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27889701/publishing-interim-results-of-randomised-clinical-trials-in-peer-reviewed-journals
#15
Nicholas Counsell, Despina Biri, Joanna Fraczek, Allan Hackshaw
BACKGROUND: Interim analyses of randomised controlled trials are sometimes published before the final results are available. In several cases, the treatment effects were noticeably different after patient recruitment and follow-up completed. We therefore conducted a literature review of peer-reviewed journals to compare the reported treatment effects between interim and final publications and to examine the magnitude of the difference. METHODS: We performed an electronic search of MEDLINE from 1990 to 2014 (keywords: 'clinical trial' OR 'clinical study' AND 'random*' AND 'interim' OR 'preliminary'), and we manually identified the corresponding final publication...
February 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27798376/leveraging-contact-network-structure-in-the-design-of-cluster-randomized-trials
#16
Guy Harling, Rui Wang, Jukka-Pekka Onnela, Victor De Gruttola
BACKGROUND: In settings like the Ebola epidemic, where proof-of-principle trials have provided evidence of efficacy but questions remain about the effectiveness of different possible modes of implementation, it may be useful to conduct trials that not only generate information about intervention effects but also themselves provide public health benefit. Cluster randomized trials are of particular value for infectious disease prevention research by virtue of their ability to capture both direct and indirect effects of intervention, the latter of which depends heavily on the nature of contact networks within and across clusters...
February 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27646508/the-design-and-conduct-of-keep-it-off-an-online-randomized-trial-of-financial-incentives-for-weight-loss-maintenance
#17
Pamela A Shaw, William S Yancy, Lisa Wesby, Victoria Ulrich, Andrea B Troxel, David Huffman, Gary D Foster, Kevin Volpp
Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors...
February 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27625314/a-randomized-study-of-multimedia-informational-aids-for-research-on-medical-practices-implications-for-informed-consent
#18
Stephanie A Kraft, Melissa Constantine, David Magnus, Kathryn M Porter, Sandra Soo-Jin Lee, Michael Green, Nancy E Kass, Benjamin S Wilfond, Mildred K Cho
BACKGROUND/AIMS: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices...
February 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27590208/comparison-of-futility-monitoring-guidelines-using-completed-phase-iii-oncology-trials
#19
Qiang Zhang, Boris Freidlin, Edward L Korn, Susan Halabi, Sumithra Mandrekar, James J Dignam
BACKGROUND: Futility (inefficacy) interim monitoring is an important component in the conduct of phase III clinical trials, especially in life-threatening diseases. Desirable futility monitoring guidelines allow timely stopping if the new therapy is harmful or if it is unlikely to demonstrate to be sufficiently effective if the trial were to continue to its final analysis. There are a number of analytical approaches that are used to construct futility monitoring boundaries. The most common approaches are based on conditional power, sequential testing of the alternative hypothesis, or sequential confidence intervals...
February 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27559021/a-bayesian-response-adaptive-trial-in-tuberculosis-the-endtb-trial
#20
Matteo Cellamare, Steffen Ventz, Elisabeth Baudin, Carole D Mitnick, Lorenzo Trippa
PURPOSE: To evaluate the use of Bayesian adaptive randomization for clinical trials of new treatments for multidrug-resistant tuberculosis. METHODS: We built a response-adaptive randomization procedure, adapting on two preliminary outcomes for tuberculosis patients in a trial with five experimental regimens and a control arm. The primary study outcome is treatment success after 73 weeks from randomization; preliminary responses are culture conversion at 8 weeks and treatment success at 39 weeks...
February 2017: Clinical Trials: Journal of the Society for Clinical Trials
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