The authors recommend that a system of expanded access to clinical trial data apply to trials of all approved prescription drugs, medical devices, and biologics; and treat all trial sponsors and qualified data requesters evenhandedly. It should have mechanisms to ensure that all sponsors and data users adhere to minimum standardsfor example, rules should specify what must be shared, and data users should commit to following a scientifically sound analytical plan. If sponsors are permitted to influence which data requests get granted, they should be required to apply explicit decision criteria and publicly explain the reasons for denials. Using an independent intermediary organization to make those decisions, however, may be preferable.
"As in other areas of health care, the push for greater transparency in the area of clinical-trial data appears inexorable," the authors wrote. "The question is not whether, but how, these data should be broadly shared. The potential risks to research participants and trial sponsors must be thoughtfully addressed in the design of any new data-sharing system but need not block progress toward achieving the promise of 'big data' in the clinical trials context."
"The European Medicines Agency has hastened to impose regulatory mandates for data sharing, which may indeed be needed," said Mark Barnes, a partner at Ropes & Gray LLP and the Harvard faculty co-director of MRCT, "but such mandates need to be carefully considered, to avoid harms to participants and to preserve commercial incentives for i
|Contact: Marge Dwyer|
Harvard School of Public Health