The Institute of Medicine (IOM) of the National Academies released the report “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk” on January 14, 2015. It concludes that data sharing is in the public interest, but an effort on the part of many stakeholders is needed “to develop a culture, infrastructure, and policies that will foster responsible sharing – now and in the future.”
In the report, the IOM calls upon the research community to enhance data sharing activities and provides specific actions for all segments, including government agencies, scientists, journals, and research institutions. In addition, the document details further responsibilities of data-holders to guard against misuse. An optimal timeline for clinical data sharing is also proposed. Recognizing the many challenges and barriers to data sharing, the IOM report indicates that longer timeframes will be required initially.
FASEB provided comments on the IOM’s early discussion framework on clinical trial data sharing. FASEB’s statement highlighted key barriers and suggested that greater automation, standardization, and interoperability would enhance sharing. Further incentives are also required as the majority of the effort in data sharing is born by the original collectors and benefits primarily accrue to secondary users. FASEB also described the evolving risks to patient privacy, and recommended that alternative models for protecting participants be explored.