The global clinical research enterprise generates reams of data, but much of it never sees the light of day. Although some study findings are published in journals, in other cases, summary results may be submitted to a clinical trial registry, or data may be submitted to regulators as a condition of marketing approval. Some data never leave the hands of the researchers who generate it.
This patchy access to data means that clinicians and patients are unaware of information that may be important. It may lead to a skewed portrayal of the efficacy or safety of an intervention. It may also violate researchers’ ethical obligations to study participants. These concerns have led to a growing movement to expand access to clinical trial data. To help guide this effort, the Institute of Medicine (IOM) convened a committee to create a framework for how such data should be shared. In January 2014, a draft of the framework was released for public comment.
Kuehn BM. IOM Outlines Framework for Clinical Data Sharing, Solicits Input. JAMA. 2014;311(7):665. doi:10.1001/jama.2014.884