Sharing Clinical Research Data – Institute of Medicine Workshop Summary – 29 March 2013

Posted on April 2, 2013. Filed under: Research | Tags: , |

Sharing Clinical Research Data – Institute of Medicine Workshop Summary – 29 March 2013

“Pharmaceutical companies, academic researchers, and government agencies compile large quantities of clinical research data, which, if shared more widely both within and across sectors, could improve public health, enhance patient safety, and spur drug development. Data sharing also can increase public trust in clinical trials and the conclusions derived from them by lending transparency to the clinical research process.

Despite several barriers to data sharing – such as concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation – there is increasing acknowledgement among researchers of the importance and potential benefits to sharing clinical research data at various stages of the research, discovery, and development pipeline.

On October 4-5, 2012, four groups within the IOM – the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Translating Genomic-Based Research for Health – hosted a workshop to explore the benefits of sharing clinical research data, the barriers to such sharing, and strategies to address these barriers to facilitate the development of safe, effective therapeutics and diagnostics. This document summarizes the workshop.

As follow up to this workshop the IOM is in the process of developing a consensus study that will focus on the open availability and use of clinical trial data.”

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