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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/29400066/increasing-the-use-of-mobile-technology-derived-endpoints-in-clinical-trials
#1
William G Herrington, Jennifer C Goldsack, Martin J Landray
No abstract text is available yet for this article.
February 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29376735/adaptive-parametric-prediction-of-event-times-in-clinical-trials
#2
Yu Lan, Daniel F Heitjan
BACKGROUND: In event-based clinical trials, it is common to conduct interim analyses at planned landmark event counts. Accurate prediction of the timing of these events can support logistical planning and the efficient allocation of resources. As the trial progresses, one may wish to use the accumulating data to refine predictions. PURPOSE: Available methods to predict event times include parametric cure and non-cure models and a nonparametric approach involving Bayesian bootstrap simulation...
January 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29374974/impact-of-stochastically-generated-heterogeneity-in-hazard-rates-on-individually-randomized-vaccine-efficacy-trials
#3
Rebecca Kahn, Matt Hitchings, Steven Bellan, Marc Lipsitch
Background/aims Network structure and individuals' level of exposure to a pathogen can impact results from efficacy evaluation studies of interventions against infectious diseases. Heterogeneity in infection risk can cause randomized groups to increasingly differ as a trial progresses and as more high-risk individuals become infected (described in prior work as the "frailty" phenomenon). Here, we show the impact this phenomenon can have on an individually randomized trial of a leaky vaccine in which all participants are exchangeable a priori...
January 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29361833/are-pilot-trials-useful-for-predicting-randomisation-and-attrition-rates-in-definitive-studies-a-review-of-publicly-funded-trials
#4
Cindy L Cooper, Amy Whitehead, Edward Pottrill, Steven A Julious, Stephen J Walters
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...
January 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29316807/cost-efficient-designs-for-three-arm-trials-with-treatment-delivered-by-health-professionals-sample-sizes-for-a-combination-of-nested-and-crossed-designs
#5
Mirjam Moerbeek
Background This article studies the design of trials that compare three treatment conditions that are delivered by two types of health professionals. The one type of health professional delivers one treatment, and the other type delivers two treatments, hence, this design is a combination of a nested and crossed design. As each health professional treats multiple patients, the data have a nested structure. This nested structure has thus far been ignored in the design of such trials, which may result in an underestimate of the required sample size...
January 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29366329/rationale-and-design-of-the-smart-trial-a-randomised-prospective-parallel-non-blinded-one-centre-trial-to-evaluate-the-use-of-magnetic-resonance-imaging-in-acute-setting-in-patients-presenting-with-suspected-scaphoid-fracture
#6
Tiago Rua, Sanjay Vijayanathan, David Parkin, Vicky Goh, Paul McCrone, Sam Gidwani
Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures...
December 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29361843/use-of-online-recruitment-strategies-in-a-randomized-trial-of-cancer-survivors
#7
Stephen P Juraschek, Timothy B Plante, Jeanne Charleston, Edgar R Miller, Hsin-Chieh Yeh, Lawrence J Appel, Gerald J Jerome, Debra Gayles, Nowella Durkin, Karen White, Arlene Dalcin, Manuel Hermosilla
BACKGROUND/AIMS: Despite widespread Internet adoption, online advertising remains an underutilized tool to recruit participants into clinical trials. Whether online advertising is a cost-effective method to enroll participants compared to other traditional forms of recruitment is not known. METHODS: Recruitment for the Survivorship Promotion In Reducing IGF-1 Trial, a community-based study of cancer survivors, was conducted from June 2015 through December 2016 via in-person community fairs, advertisements in periodicals, and direct postal mailings...
December 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29250989/twic-or-treat-are-trials-within-cohorts-ethically-defensible
#8
Charles Weijer, Cory E Goldstein, Monica Taljaard
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/29250988/innovative-approaches-to-informed-consent-for-randomized-clinical-trials-identifying-the-ethical-challenges
#9
David Wendler
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/29235369/academic-chartered-data-safety-committees-versus-industry-sponsored-data-safety-committees-the-need-for-different-recommendations
#10
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
#11
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
#12
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
#13
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/29452522/the-evolution-of-clinical-trials-can-we-address-the-challenges-of-the-future
#14
Hans-Georg Eichler, Fergus Sweeney
The authors describe key challenges facing the clinical trials community and propose solutions to these issues, including the role the Clinical Trials Transformation Initiative can play in addressing these issues. Specifically, the authors reflect on clinical trial globalization and the harmonization of frameworks and requirements across regions; the challenges associated with balancing the desire for external validity, pragmatic trials, and precision medicine; clinical trial transparency; and operational complexity and the expense of clinical trials...
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29452521/clinical-trial-quality-from-supervision-to-collaboration-and-beyond
#15
Ann Meeker-O'Connell, Coleen Glessner
Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct...
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29452520/the-clinical-trials-transformation-initiative-methodology-supporting-the-mission
#16
Amy Corneli, Zachary Hallinan, Gerrit Hamre, Brian Perry, Jennifer C Goldsack, Sara B Calvert, Annemarie Forrest
The mission of the Clinical Trials Transformation Initiative, a public-private partnership co-founded by the U.S. Food and Drug Administration and Duke University, is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. The Clinical Trials Transformation Initiative works collaboratively with key stakeholders, implements "fit-for-purpose" evidence-gathering projects, and develops actionable recommendations and tools to address the challenges faced by the clinical trials enterprise...
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29452519/patient-engagement-in-clinical-trials-the-clinical-trials-transformation-initiative-s-leadership-from-theory-to-practical-implementation
#17
Bray Patrick-Lake
Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts...
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29452518/the-clinical-trials-transformation-initiative-looking-back-looking-forward
#18
John H Alexander, Jacqueline Corrigan-Curay, Mark McClellan
No abstract text is available yet for this article.
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29452517/a-decade-of-the-clinical-trials-transformation-initiative-what-have-we-accomplished-what-have-we-learned
#19
P Tenaerts, L Madre, M Landray
The Clinical Trials Transformation Initiative reflects on 10 years of working to improve the quality and efficiency of clinical trials. This article highlights many of the Clinical Trials Transformation Initiative's accomplishments and offers examples of the impact that the Clinical Trials Transformation Initiative has had on the clinical trials enterprise. After conducting more than 25 projects and issuing recommendations for specific strategies to improve the design and execution of clinical trials, some common themes and lessons learned have emerged...
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29400564/rejoinder
#20
Scott Yh Kim, James Flory, Clare Relton
No abstract text is available yet for this article.
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
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