Article > J&J to share clinical-trial data through Yale open-access project

"Johnson & Johnson has joined other leading pharmaceutical companies in addressing demand for broader access to clinical-trial results by putting data-sharing decisions in the hands of an independent third party.  J&J’s US-based subsidiary Janssen Research and Development has agreed to share data from the Johnson & Johnson pharmaceutical operations through the Yale School of Medicine Open Data Access (YODA) Project. Recently, Boehringer Ingelheim, GSK, Sanofi and ViiV Healthcare agreed to make anonymised patient-level data from their clinical trials available to researchers on request through a new online portal launched by enterprise-software specialist ideaPoint ... Yoda has developed a model to facilitate access to patient-level clinical-research data, in the hope of promoting rigorous independent analysis by external investigators. The model was first applied in practice more than two years ago, with the help of around US$2.5 million in sponsorship from Medtronic. The Yale team embarked an independent analysis of individual participant data from clinical trials of device manufacturer Medtronic’s recombinant human bone morphogenetic protein-2 (INFUSE Bone Graft), following allegations in a medical journal that study results had overstated the product’s benefits. Under the agreement with Janssen Research and Development, YODA will serve as an independent review body for requests from investigators and physicians seeking access to anonymised Janssen clinical-trial data. YODA will also make final decisions on whether to share these data. According to Johnson & Johnson, this is 'the first time any company has collaborated with completely independent third party to review and make decisions regarding every request for clinical data.'  As an indication of YODA’s independence, the review of Medtronic’s INFUSE essentially found the product to be no more effective on clinically meaningful measures than traditional bone grafts, and with a potential increase in risk."