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Panel Recommends Steps for Sharing Patient Trial Data

Michelle Mello

Michelle Mello (Harvard School of Public Health)

A study group of academics and pharmaceutical industry experts convened by the Multi-Regional Clinical Trials Center at Harvard University recommends expanding access to data from clinical trials, including data on individual participants, under tight protocols and conditions. The team led by Harvard law and public health professor Michelle Mello published its findings and recommendations yesterday in the New England Journal of Medicine.

The group’s report cites recent actions encouraging more access to clinical trial data including a decision of the European Medicines Agency in June 2013 to provide public access to participant-level data. Likewise the Institute of Medicine convened a committee to establish a process for expanded public access to clinical trial data. That committee is expected to meet on 23 October; the study group timed the release of its report in NEJM to coincide with that meeting.

“Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data,” says Mello in a university statement. “The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants’ privacy, avoiding ‘junk science,’ and minimizing burdens on trial sponsors?”

Mello and colleagues spelled out the benefits and risks of making clinical trial data more accessible. The group noted that more access can help verify claims by trial sponsors of a product’s effectiveness and safety, as well as encouraging further studies, exploring for example, the effects of drugs or devices on smaller sub-groups in the target population or expanding the inquiry to more diverse populations.

The risks identified by the study group, however, are significant. Even when clinical data sets are stripped of identifying information, individuals may still be identified, such as through genomic indicators. In addition, individuals with an axe to grind could cherry-pick participant-level data to score points rather than improve health outcomes. Even patent law issues are involved, where premature release of clincial data could be considered “prior art,” with implications for the intellectual property value of the therapy or device.

The researchers recommend establishing a process of expanding access to clinical trial data that adheres to a set of principles and minimum standards and applied even-handedly to all trial sponsors and requests for data. Requests, say the group, should identify the persons seeking the data, spell out the research questions for which they need answers, and provide a detailed analysis plan.

The team identified four potential models for expanding access to clinical trial data: (1) completely open access, (2) requesters submit research questions that are run by the data owners, (3) release data to requesters but under control of the trial sponsors, and (4) an independent board to evaluate data requests and enforce conditions on data use. While the group did not explicitly endorse one of the models, its analysis of their pros and cons seemed to favor the independent board.

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