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1 Introduction and Themes of the Workshop
Pages 1-8

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From page 1...
... Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information.
From page 2...
... Despite these barriers, there is increasing acknowledgment among researchers of the importance and potential benefits to sharing clinical research data at various stages of the research, discovery, and development pipeline. Precompetitive collaboration models promote the sharing of resources and risk among competitors at early stages of the research process, with the goal of providing benefit to all parties.
From page 3...
... The workshop objectives were to  examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: -- -- benefits to the research and development enterprise and -- -- benefits to the analysis of safety and efficacy;  identify barriers and challenges to sharing clinical research data;  explore strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities; and  discuss strategies for using these potentially large datasets to facilitate scientific and public health advances. along with issues that warrant more focused attention.
From page 4...
... " The benefits of sharing research data have been amply demonstrated in areas such as cardiovascular disease, where death rates have fallen 40 percent in recent decades, pointing toward the great potential of data sharing to improve human health, said William Potter, co-chair emeritus of the Neuroscience Steering Committee for the Biomarkers Consortium of the Foundation for the National Institutes of Health, in his summary of major messages from the first session of the workshop. Building and sharing datasets within and across the public and private sectors are practices that should be widely emulated.
From page 5...
... Transparency in the use and dissemination of data can strengthen public trust in the biomedical research enterprise. Finally, he said, regulatory agencies are also recognizing the importance of facilitating this process and are working with researchers in academia and industry to identify paths forward.
From page 6...
... Data sharing is a public good, and the actions of the biomedical research enterprise should reflect that good, observed Robert Harrington, Arthur L Bloomfield Professor of Medicine and chair of the department of medicine at Stanford University.
From page 7...
... Journals could agree on standard practices that authors must follow. A culture of data sharing could be built into the education of the next generation of clinical researchers.


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