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Data Sharing Priorities

Pharmalot's Ed Silverman speaks with Institute of Medicine committee member Ida Sim about the report it released last week on sharing clinical trial data.

The report encourages researchers to share summary-level results from clinical trials within a year of their end date and offers recommendations on how to go about sharing data to "maximize the benefits and minimize the risks."

Critics noted that the report focused on sharing data generated by new trials, rather than data that's already been collected.

Sim, who is also a professor at the University of California, San Francisco, tells Silverman that the committee did think about such legacy trials, but that they pose special challenges. Most participants in such older trials were not asked for their consent to share their data, and to ethically share such data, researchers would have to go back and re-consent the participants.

"Well, that said, for major significant trials that do influence decisions for clinical care, we recommend that, on a case-by-case basis, legacy studies should be prioritized for data sharing," she adds. "But we have to be pragmatic and realistic."

Overall, Sim says principal investigators need to be "agreeable to data sharing" and that sharing has to be prioritized by the scientific community.