Review: Sharing Clinical Trial Data 1/2

18. october 2015 at 8:00 | Veronika Valdova, ARETE-ZOE |  Risk Management

Review:Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Committee on Strategies for Responsible Sharing of Clinical Trial Data; Board on Health Sciences Policy; Institute of Medicine (2015)

According to Bernard Lo, M.D., Chair of the Committee on Strategies for Responsible Sharing of Clinical Trial Data, both patients and their physicians depend on clinical trials for evidence of efficacy and safety of therapies. Responsible sharing clinical trial data raises complex issues and challenges with regards to jurisdictional differences, privacy concerns, and variety of designs utilizing different kind of data (p x).

The Committee was formed to develop guiding principles and a framework (activities and strategies) for the responsible sharing of clinical trial data (p xiii). The report assesses how key stakeholders including participants, sponsors, regulators, investigators, research institutions, journals, and professional societies assess the benefits, risks, and challenges of data sharing. The recommendations include fostering culture of data sharing in reasonable timeframe in a transparent way. The Committee suggests creation of "a multi-stakeholder body with global reach and broad representation to address the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data" (p xiv).

Data sharing means that data from scientific studies is made available for secondary uses, namely reanalysis to check replicability and validity, meta-analyses and de-novo analyses (p 24).

Chapter 2 presents the major potential benefits and risks of sharing clinical trial data and sets forth the guiding principles. In Chapter 3, stakeholders are identified, including their roles and responsibilities, and the benefits and risks of data sharing from their perspectives. Chapters 4 and 5 discuss type of data and timelines and methods of data sharing. Visions for data sharing are presented in Chapter 6 (p 27).

Sharing of clinical trial data has great potential to accelerate scientific progress and improve public health. Data sharing increases contributions of trial participants to beyond narrow interests of the sponsor. The potential benefits need to be weighed against any potential harm, namely legitimate protection of intellectual property and privacy concerns which could potentially deter people from participating in trials. Distorted and invalid analyses may lead to lawsuits for negligence and burdensome responses. Additionally, qui tam lawsuits create a conflict of interest in the U.S. (p 34). The most important benefit of data sharing in intangible, though:

"Public trust is an intrinsic value undergirding the biomedical science and health research enterprise, which is fundamentally aimed at improving human health. At a more instrumental level, trust also is essential for ensuring continued public support for clinical research and for fostering participation in clinical trials" (p 38).

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