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Is YODA wise enough to navigate a global public-private data project?

Johnson & Johnson recently announced that its subsidiary, Janssen Research and Development, LLC, will partner with the Yale School of Medicine's Open Data Access (YODA) project to share anonymized clinical trial data. The project seeks to provide "rigorous and objective evaluation of clinical trial data to ensure that patients and physicians possess all necessary information about a drug or device when making treatment decisions." Janssen is the first company to partner with the project.

Pharmaceutical and biotechnology companies may not publish the results of clinical studies they conduct in peer-reviewed journals. These unpublished data may include results from randomized clinical trials, used to determine the safety and efficacy of new drugs and therapeutics. The YODA project aims to make patient-level clinical research data accessible for review by independent scientists and physicians.

The project wants such reviews to be objective, rigorous and transparent. To accomplish these goals, the project has four key features:

—A requirement that any company participating in YODA must provide all relevant product data;

—Two competitively selected research groups to review all data;

—A clinical advisory committee made up of clinicians and an independent steering committee, including clinical researchers and biomedical ethicists; and

—A commitment to transparency, publication and public access to data.

For the partnership, Janssen will decide what data it gives to the YODA project, but the company publicly supports sharing and disclosure of clinical data. The YODA committees will decide which research groups receive access to Janssen's data after reviewing all requests.

No one is quite sure what this partnership will yield. Yale received the funding to test YODA from Medtronic and conducted an independent review of the scientific research—including clinical trial and post-marketing data—on the safety and efficacy of the company's recombinant bone morphogenetic protein-2 product. The results of these analyses were published in June 2013 and are accessible through the YODA website.

While the YODA project currently involves only American companies, there also are efforts underway in Europe to increase the transparency of clinical trials. The European Medicines Agency—responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union—is developing a policy on publication and access to clinical trial data. In response to the many and lengthy comments it received during public consultation on the proposed policy, the EMA has delayed implementation of the policy to perform a more in-depth analysis. Perhaps European regulators are looking to include outcomes from public-private partnerships in their analysis.

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