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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/27889701/publishing-interim-results-of-randomised-clinical-trials-in-peer-reviewed-journals
#1
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...
November 26, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27885056/understanding-the-functions-and-operations-of-data-monitoring-committees-survey-and-focus-group-findings
#2
Karim A Calis, Patrick Archdeacon, Raymond P Bain, Annemarie Forrest, Jane Perlmutter, David L DeMets
BACKGROUND: The use of data monitoring committees in the conduct of clinical trials has increased and evolved, but there is a lack of published information on when data monitoring committees are needed and utilized, the acceptable range of data monitoring committee practices, and appropriate qualifications of data monitoring committee members. METHODS: To gain a better understanding of data monitoring committee operations and areas for improvement, the Clinical Trials Transformation Initiative conducted a survey and set of focus groups...
November 24, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27798377/maximizing-value-and-minimizing-barriers-patient-centered-community-consultation-for-research-in-emergency-settings
#3
Christopher B Fordyce, Matthew T Roe, Neal W Dickert
BACKGROUND: Patients with cardiac arrest and other life-threatening emergencies are unable to provide prospective consent for clinical trials. In the United States and other countries, regulations permit an exception from the requirement for informed consent in emergency settings. However, many potential barriers exist, as evidenced by the scarcity of US trials conducted under exception from the requirement for informed consent. One persistent challenge is the requirement that investigators consult communities prior to study approval...
October 25, 2016: 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
#4
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...
October 24, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27780884/strength-of-evidence-for-labeled-dosing-recommendations-in-renal-impairment
#5
Joshua J Gagne, Nazleen F Khan, Tara S Raj, Lajja R Patel, Niteesh K Choudhry
BACKGROUND/AIMS: Renally excreted medications often require dose adjustment in patients with kidney impairment. While drug development and approval in the United States are typically based on several Phase I and II studies and one or more larger Phase III randomized trials, the basis for labeled dosing recommendations for patients with renal impairment is less well known. In response, we aimed to quantify the level of evidence used to recommend labeled dosing adjustments for newly approved drugs in patients with renal impairment...
October 24, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27729499/bayesian-survival-analysis-in-clinical-trials-what-methods-are-used-in-practice
#6
Caroline Brard, Gwénaël Le Teuff, Marie-Cécile Le Deley, Lisa V Hampson
BACKGROUND: Bayesian statistics are an appealing alternative to the traditional frequentist approach to designing, analysing, and reporting of clinical trials, especially in rare diseases. Time-to-event endpoints are widely used in many medical fields. There are additional complexities to designing Bayesian survival trials which arise from the need to specify a model for the survival distribution. The objective of this article was to critically review the use and reporting of Bayesian methods in survival trials...
October 10, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27681658/challenges-encountered-in-the-conduct-of-optimal-health-a-patient-centered-comparative-effectiveness-study-of-interventions-for-adults-with-serious-mental-illness
#7
Jane N Kogan, James Schuster, Cara Nikolajski, Patricia Schake, Tracy Carney, Sally C Morton, Chaeryon Kang, Charles F Reynolds
BACKGROUND: The aim of patient-centered comparative effectiveness research is to conduct stakeholder-driven investigations that identify which interventions are most effective for which patients under specific circumstances. Conducting this research in real-world settings comes with unique experiences and challenges. We provide the study design, challenges confronted, and the solutions we devised for Optimal Health, a stakeholder-informed patient-centered comparative effectiveness study focused on the needs of seriously mentally ill individuals receiving case management services in community mental health centers across Pennsylvania...
September 28, 2016: 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
#8
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...
September 19, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27625315/clinical-trial-ids-need-to-be-validated-prior-to-publication-because-hundreds-of-invalid-national-clinical-trial-identifications-are-regularly-entering-medline
#9
Jonathan D Wren
No abstract text is available yet for this article.
September 13, 2016: 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
#10
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...
September 13, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27903947/daniel-j-sargent-1970-2016
#11
Sumithra J Mandrekar
No abstract text is available yet for this article.
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27903946/editorial
#12
EDITORIAL
Colin B Begg
No abstract text is available yet for this article.
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27573636/communicating-with-participants-during-the-conduct-of-multi-center-clinical-trials
#13
Erika F Augustine, E Ray Dorsey, Robert A Hauser, Jordan J Elm, Barbara C Tilley, Karl K Kieburtz
BACKGROUND: Communicating with trial participants is an important aspect of study conduct, relevant for informed consent and respect for participants. Group teleconferences are one means to convey information to trial participants. We used group teleconferences during an ongoing large-scale clinical trial to communicate important trial updates. METHODS: The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Longitudinal Study-1 trial studied creatine for treatment of early-stage Parkinson's disease...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27573635/clinical-trial-result-reporting-time-to-move-into-the-21st-century
#14
Sharon F Terry
No abstract text is available yet for this article.
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27562368/health-research-participants-preferences-for-receiving-research-results
#15
Christopher R Long, M Kathryn Stewart, Thomas V Cunningham, T Scott Warmack, Pearl A McElfish
BACKGROUND: Participants in health research studies typically express interest in receiving the results from the studies in which they participate. However, participants' preferences and experiences related to receiving the results are not well understood. In general, the existing studies have had relatively small sample sizes and typically address specific and often sensitive issues within targeted populations. METHODS: This study used an online survey to explore attitudes and experiences of registrants in ResearchMatch, a large database of past, present, and potential health research participants...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27559022/adult-patient-perspectives-on-clinical-trial-result-reporting-a-survey-of-cancer-patients
#16
Kate E Elzinga, Omar F Khan, Andrew R Tang, Conrad V Fernandez, Christine L Elzinga, Daniel Yc Heng, Michael M Vickers, Tony H Truong, Patricia A Tang
BACKGROUND: The provision of study results to research participants is supported by pediatric and adult literature. This study assessed adult cancer patient preferences surrounding aggregate result disclosure to study participants. METHODS: A 46-item questionnaire was given to 250 adult cancer patients who had participated in oncology trials at a single center. Respondents answered questions surrounding their preferences for timing, content, and modality of communication for dissemination of study results...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27439306/non-factorial-analyses-of-two-by-two-factorial-trial-designs
#17
Edward L Korn, Boris Freidlin
BACKGROUND/AIMS: Factorial analyses of 2 × 2 trial designs are known to be problematic unless one can be sure that there is no interaction between the treatments (A and B). Instead, we consider non-factorial analyses of a factorial trial design that addresses clinically relevant questions of interest without any assumptions on the interaction. Primary questions of interest are as follows: (1) is A better than the control treatment C, (2) is B better than C, (3) is the combination of A and B (AB) better than C, and (4) is AB better than A, B, and C...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27430710/a-practical-bayesian-stepped-wedge-design-for-community-based-cluster-randomized-clinical-trials-the-british-columbia-telehealth-trial
#18
Kristen M Cunanan, Bradley P Carlin, Kevin A Peterson
BACKGROUND: Many clinical trial designs are impractical for community-based clinical intervention trials. Stepped wedge trial designs provide practical advantages, but few descriptions exist of their clinical implementational features, statistical design efficiencies, and limitations. OBJECTIVES: Enhance efficiency of stepped wedge trial designs by evaluating the impact of design characteristics on statistical power for the British Columbia Telehealth Trial. METHODS: The British Columbia Telehealth Trial is a community-based, cluster-randomized, controlled clinical trial in rural and urban British Columbia...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27430709/non-inferiority-tests-for-anti-infective-drugs-using-control-group-quantiles
#19
Michael P Fay, Dean A Follmann
BACKGROUND/AIMS: In testing for non-inferiority of anti-infective drugs, the primary endpoint is often the difference in the proportion of failures between the test and control group at a landmark time. The landmark time is chosen to approximately correspond to the qth historic quantile of the control group, and the non-inferiority margin is selected to be reasonable for the target level q. For designing these studies, a troubling issue is that the landmark time must be pre-specified, but there is no guarantee that the proportion of control failures at the landmark time will be close to the target level q...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27371945/a-novel-drug-management-system-in-the-febuxostat-versus-allopurinol-streamlined-trial-a-description-of-a-pharmacy-system-designed-to-supply-medications-directly-to-patients-within-a-prospective-multicenter-randomised-clinical-trial
#20
Amy Rogers, Robert Wv Flynn, Patrick McDonnell, Isla S Mackenzie, Thomas M MacDonald
BACKGROUND: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial. METHOD: A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
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