Journal ArticleDOI
Access to data in industry-sponsored trials.
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This article is published in The Lancet.The article was published on 2011-12-10. It has received 26 citations till now. The article focuses on the topics: Data access.read more
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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.
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,Summerskill Wsm.,Trish Groves,K F Schulz,Harold Sox,Frank W. Rockhold,M 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.
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.
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A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry Sponsors
Kevin A. Schulman,Damon M. Seils,Justin W. Timbie,Jeremy Sugarman,Lauren Dame,Kevin P. Weinfurt,Daniel B. Mark,Robert M. Califf +7 more
TL;DR: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights, and suggest that a reevaluation of the process of contracting for clinical research is urgently needed.
Journal ArticleDOI
Why we need easy access to all data from all clinical trials and how to accomplish it
TL;DR: It is argued that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests, and why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available.
Journal ArticleDOI
Constraints on publication rights in industry-initiated clinical trials.
Peter C Gøtzsche,Asbjørn Hróbjartsson,Helle Krogh Johansen,Mette T. Haahr,Douglas G. Altman,An-Wen Chan +5 more
Journal ArticleDOI
Data availability for industry sponsored trials: what should medical journals require?
TL;DR: There is a strong case for journals defining full access to the trial data and requiring that investigators and journal editors have full access, writes Robert Steinbrook and Jerome P Kassirer.