Access to regulatory data from the European Medicines Agency: the times they are a-changing

by Beate Wieseler, Natalie McGauran, Michaela F Kerekes, Thomas Kaiser

a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.

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Jimmy Whitworth calls for a more sustainable and palatable pathway be will to build consensus and to create a broad coalition.

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Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits

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In this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically

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A systematic review of barriers to data sharing in public health

by Willem G van Panhuis, Proma Paul, Claudia Emerson, John Grefenstette, Richard Wilder, Abraham J Herbst, David Heymann, Donald S Burke

This study looks at the challneges of data sharing globally. 

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Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons

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Prepublication data sharing

by Toronto International Data Release Workshop Authors

Rapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.

22nd February 2018 • 0 comments

Sharing health data: developing country perspectives

by Viroj Tangcharoensathien, Jirawan Boonperm, Pongpisut Jongudomsuk

Sharing data is not only about the technical dimension such as data management, repositories and libraries; developing countries are concerned about factors that impede data sharing, in particular, fairness

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Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

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John A. Spertus suggests that there needs to be some consideration about the practicalities of data sharing- in how it is shared, investment, and ensuring that data are appropriately analyzed 

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This article argues that scientists need to feel greater urgency to share their findings quickly, and they need additional avenues to facilitate this process.

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This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.

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This article looks at the benefits of data sharing, and argues for increasing the accessibility of data

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This article details the procedures and requirements for researchers in sharing data from clinical trials. 

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This article proposes some key characteristics needed in a clinical data warehouses for biomedical research

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This article asks the question: how do we achieve fair trade in the sharing of clinical data?

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The International Stroke Trial database

by Peter AG Sandercock, Maciej Niewada, Anna Członkowska, the International Stroke Trial Collaborative Group

We aimed to make individual patient data from the International Stroke Trial (IST),  available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.

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This article argues against selective publication and for a clear view of the totality of evidence relevant to many research questions and clinical decisions.

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Policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators.

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Clinical trial data as a public good

by Marc A. Rodwin, John D. Abramson

Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.

22nd February 2018 • 0 comments