Transparency and sharing of information from clinical trials has been gathering support from industry, the government, researchers, and medical journals. As support has grown, the challenges associated with how and when data should be shared have become more apparent. As such, the Institute of Medicine's (IOM) committee on Strategies for Responsible Sharing of Clinical Trial Data was created to address the issues. The authors of an ideas and opinions paper being published in Annals of Internal Medicine call for a consistent approach to data-sharing.
A benefit-risk assessment should be done to determine whether potential benefits of data sharing, such as clarifying the safety and efficacy of a therapy, preventing repetition of clinical trials that unnecessarily expose patients to new agents, and improving transparency and public trust, outweigh potential risks. The risks may include sharing incorrect or misleading information, issues related to patient consent, and privacy. The authors remind stakeholders that it is not possible to make digital records completely secure or to guarantee patient data security.
The author of an accompanying editorial writes about the technical, procedural and political challenges associated with data sharing. He suggests that stakeholders work together to protect both the science behind the clinical data and the patients.