Journal ArticleDOI
SPIRIT 2013: new guidance for content of clinical trial protocols.
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This article is published in The Lancet.The article was published on 2013-01-12. It has received 213 citations till now. The article focuses on the topics: Clinical trial & MEDLINE.read more
Citations
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Increasing value and reducing waste: addressing inaccessible research.
An-Wen Chan,Fujian Song,Andrew J. Vickers,Tom Jefferson,Kay Dickersin,Peter C Gøtzsche,Harlan M. Krumholz,Harlan M. Krumholz,Davina Ghersi,H. Bart van der Worp +9 more
TL;DR: Three main actions are warranted: academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets, and standards for the content of protocols and full study reports should be rigorously developed and adopted for all types of health research.
Journal ArticleDOI
Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk
TL;DR: It is concluded that sharing data is in the public interest, but a multi-stakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing—now and in the future.
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Blockchain technology for improving clinical research quality
TL;DR: The core functionalities of Blockchain applied to clinical trials are explored and its general principle in the context of consent to a trial protocol is illustrated concretely.
Journal ArticleDOI
Strategies to improve retention in randomised trials.
Valerie Catherine Brueton,Jayne F. Tierney,Sally P. Stenning,Seeromanie Harding,Sarah Meredith,Irwin Nazareth,Greta Rait +6 more
TL;DR: The effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting were quantified.
Journal ArticleDOI
Quality standards for real-world research. Focus on observational database studies of comparative effectiveness
Nicolas Roche,Helen K. Reddel,Richard J. Martin,Guy Brusselle,Alberto Papi,Mike Thomas,Dirjke Postma,Vicky Thomas,Cynthia S. Rand,Alison Chisholm,David Price +10 more
TL;DR: Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results.
References
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Journal ArticleDOI
SPIRIT 2013 statement: defining standard protocol items for clinical trials.
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman,Andreas Laupacis,Peter C Gøtzsche,Karmela Krleža-Jerić,Asbjørn Hróbjartsson,Howard Mann,Kay Dickersin,Jesse A. Berlin,Caroline J Doré,Wendy R. Parulekar,William S.M. Summerskill,Trish Groves,Kenneth F. Schulz,Harold C. Sox,Frank W. Rockhold,Drummond Rennie,David Moher +18 more
TL;DR: The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol, is presented in this paper.
Journal ArticleDOI
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
An-Wen Chan,Jennifer Tetzlaff,Peter C Gøtzsche,Douglas G. Altman,Howard Mann,Jesse A. Berlin,Kay Dickersin,Asbjørn Hróbjartsson,Kenneth F. Schulz,Wendy R. Parulekar,Karmela Krleza-Jeric,Andreas Laupacis,David Moher,David Moher +13 more
TL;DR: The SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations and strongly recommends that this explanatory paper be used in conjunction with the SPIRit Statement.
Journal ArticleDOI
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
TL;DR: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
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The Prevention and Treatment of Missing Data in Clinical Trials
Roderick J. A. Little,Ralph B. D'Agostino,Michael L. Cohen,Kay Dickersin,Scott S. Emerson,John T. Farrar,Constantine Frangakis,Joseph W. Hogan,Geert Molenberghs,Susan A. Murphy,James D. Neaton,Andrea Rotnitzky,Daniel O. Scharfstein,Weichung Joe Shih,Jay P. Siegel,Hal S. Stern +15 more
TL;DR: Methods for preventing missing data and, failing that, dealing with data that are missing in clinical trials are reviewed.
Journal ArticleDOI
Spirit 2013 statement: Defining standard protocol items for clinical trials
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman,Andreas Laupacis,Peter C Gøtzsche,Karmela Krleža-Jerić,Asbjørn Hróbjartsson,Howard Mann,Kay Dickersin,Jesse A. Berlin,Caroline J Doré,Wendy R. Parulekar,William S.M. Summerskill,Trish Groves,Kenneth F. Schulz,Harold C. Sox,Frank W. Rockhold,Drummond Rennie,David Moher +18 more
TL;DR: The systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 is described, a guideline for the minimum content of a clinical trial protocol.