Clinical Trial Data: Shared Resource or Private Property?
In a recently released report titled “Sharing Clinical Data – Maximizing Benefits, Minimizing Risks,” the U.S. Institute of Medicine (IOM) has called for more clinical trial data transparency1. Historically, participant-level data from clinical trials have not been shared, clinical trial sponsors have sometimes been selective about trial result summaries published in journals, and shared data have not always been posted in a timely manner or in an accessible form. The IOM report recommends making available clinical trial data as follows:
The data sharing plan should be publicly available before the first participant is enrolled.
Summary level results (including adverse event summaries) should be publicly available within twelve months after study completion, and lay-summaries of results should be made available to trial participants concurrently.
The full data package (including the full analyzable data set, full protocol, full statistical analysis plan, and analytic code) should be shared within 18 months of study completion (unless the trial is in support of a regulatory application), and no later than six months after publication.
For studies of an approved product or new indication, the post-regulatory data package (including the full analyzable data set and clinical study report redacted for commercially or personal confidential information, plus full protocol, full statistical analysis plan, and analytic code) should be shared 30 days after regulatory approval or 18 months after study completion, whichever occurs later.
For studies of a new product or new indication for a marketed product that is abandoned, the post-regulatory data package should be shared within 18 months after abandonment.
Proponents of increased transparency of clinical trial data claim that shared data will help researchers develop improved products and therapies for suffering patients. Patients participating in clinical trials are putting themselves at risk; their contribution to research may yield a better return if findings from clinical trials are effectively and efficiently shared among other researchers. Additional benefits from use of shared results from similar previous trials include cost savings, by avoiding duplication of efforts, and improved patient safety, through use of shared results from similar previous trials, which may avoid unnecessary burdens on human subjects.
With the benefits of clinical trial data transparency come some risks. One concern is the risk to trial participants’ privacy. In urging that clinical trial data be shared, the IOM has recognized the need for assuring adequate de-identification and data security processes, and has recommended the use of data use agreements that include provisions aimed at protecting clinical trial participants. The IOM also recommends that institutional review boards provide guidance on informed consent that enables responsible data sharing and research subject protection, and that IRBs consider data sharing plans when assessing the benefits and risks of clinical trials.
Another concern noted by industry sponsors is exposure of trade secrets, or analyses of the shared data that aim to discredit the clinical trial or the company sponsoring the research. The committee behind the IOM report has acknowledged these concerns, calling for “appropriate safeguards for intellectual property and commercially confidential information, and protections from invalid secondary analyses.”
The widespread use of big data in research confirms its role in shaping future research and results. Sharing the results of expensive, time-consuming clinical trials is valuable, but it requires careful planning, proper oversight, and appropriate protection of patient privacy and commercial interests. Enhanced data-sharing with effective safeguards will assure that research is launched more quickly and effectively down the path toward scientific innovation in treating and curing debilitating diseases.