Janssen, a unit of Johnson & Johnson, said today it will allow a degree of clinical-trial transparency through the Yale School of Medicine’s Open Data Access Project (YODA). YODA will act as an independent panel for the drug maker, with the panel reviewing requests from physicians and investigators for access to anonymized, clinical-trial data from Janssen’s R&D programs, including those seeking access to the company’s pharmaceutical, consumer and medical-device products.
The J&J subsidiary’s R&D arm will also handle some data requests itself. So-called “external researchers” should submit their queries to clinicaltrialstudytransparency.com for vetting by Janssen directly.
Yale School of Medicine describes the vetting process as follows: drug companies must provide all relevant product data; independent research groups are selected through an application process to analyze that product data; and an additional Steering Committee and clinical advisory team also advises the YODA project team. YODA can also reach out to Janssen researchers with additional questions, but all final decisions are to be made by the Yale group.
YODA’s objective, explained on the university’s website, is “rooted in the view that patients, providers, and industry will be better informed when academic investigators are able to facilitate the independent assessment and dissemination of data relevant to the benefits and harms of industry products.”
Janssen’s global head of R&D, Bill Hait, stated in the release, “We will now be able to share data from our clinical trial results in the form of Clinical Study Reports (CSRs) and participant level data in a systematic and objective way that advances medicine and scientific knowledge while protecting patient level data and confidentiality.”