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Secure use of individual patient data from clinical trials

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

Prepublication data sharing

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.

Sharing health data: developing country perspectives

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

Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data

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.

The double-edged sword of open access to research data

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 

The delay in sharing research data is costing lives

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

Clinical trial transparency and orphan drug development: recent trends in data sharing by the pharmaceutical industry

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

Increasing the accessibility of data

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

Introduction: data sharing and disclosure limitation techniques

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

Characteristics desired in clinical data warehouse for biomedical research

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

Sharing research data to improve public health: a perspective from the global south

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

The International Stroke Trial database

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.

Ushering in a new era of open science through data sharing: the wall must come down

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

Promoting transparency in pharmaceutical industry-sponsored research

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.

Clinical trial data as a public good

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

Data sharing in medical research: an empirical investigation

This study looks at the sharing of data between researchers; it details concerns about speed of reply, and highlights an unfortunate situation where researchers are more concerned with losing an advantage than advancing science.

Sharing of clinical trial data among trialists: a cross sectional survey

This article investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.

Improving health research governance and management in the Western Pacific: A WHO Expert Consultation

WHO organised an expert consultation on research in the Western Pacific

A mechanism for controlled access to GWAS data: experience of the GAIN Data Access Committee

This article looks at how access to GAIN information has furthered advances in he understanding of the genetic underpinnings of mental-health disorders, diabetes, and psoriasis.

Drug watchdog ponders how to open clinical trial data vault

EMA is discussing how to shape the new policy with academics, patient organizations, and drug companies; their final advice is due by the end of next month.