YODA has a possible answer to open access for sharing clinical trial data
The recently developed Yale University Open Data Access Project (YODA) Project model provides a methodology to patients and physicians for the rigorous and objective evaluation of clinical trial data. According to YODA, the project "ensure(s) that all necessary information about a drug or device when making treatment decisions" is provided without compromising data privacy. YODA helps in coordinating with the industry by analysing every request for clinical data scientifically in a manner that is precise, unbiased and fair. They do this by systematically examining all the relevant product data by "two separate qualified research groups and making all patient-level clinical research data available for analysis by other external investigators". The model is notable as it is designed to promote transparency as well as to protect against industry influence. They require companies that avail the service of YODA to provide all relevant product data. After a systematic analysis of the product data an independent Steering Committee, which includes leaders in the field of clinical research and biomedical ethics, advise the YODA project team A Clinical Advisory Committee. The YODA project emaphasises that "(their) leadership is committed to transparency, publication, and making the data publicly available".
Johnson & Johnson announced a partnership with YODA, in which they will share raw data from many of its clinical trials. This initiative in part belongs to a broader shift in both the United States and Europe, where researchers and some regulators are increasingly frustrated by the secrecy surrounding many drug trials, and want to get the information out in the open.
Go to the YODA website