IOM urges sweeping changes to clinical trial data sharing

The Institute of Medicine (IOM) has released a report calling for widespread sharing of clinical trial data.

Clinical trials generate a vast amount of data, but much of it is never made available to researchers. IOM assembled a committee to examine a political framework for responsible data sharing to advance medical science.

In its report, IOM outlined four recommendations to normalize the sharing of such data:

1. Clinical trial sharing should be expected and required as part of clinical trial protocols.
2. The full analyzable dataset of a clinical trial should be published within 18 months of a study if it is not submitted as part of regulatory approval of a project; within 30 days of a product’s regulatory approval; and within 18 months after a product is abandoned.
3. Strategies should be in place promoting data sharing and related technology platforms while increasing financial assistance.
4. The study’s sponsors, which include several pharmaceutical companies like AbbVie, Bayer, GlaxoSmithKline and Sanofi-Aventis, should lead efforts to implement the recommendations.

“Although there are technical hurdles, we need to change how we think about data. We need to view it as a community resource, much like a shared park, rather than as personal property,” said Jeffrey Drazen, MD, IOM committee member, in a related editorial that accompanied the report.

Access the report.