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.
Access to these data is subject to assessment and approval by an independent review panel, initially comprising three academics and a board member of the UK’s Clinical Research Collaboration. There is, however, a Panel Secretariat comprising data-sharing co-ordinators from the sponsors involved in the ideaPoint initiative.
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 a 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.
“We are pleased to collaborate with YODA to ensure that each and every request for access to our pharmaceutical clinical data is reviewed objectively and independently,” commented Dr Joanne Waldstreicher, chief medical officer at Johnson & Johnson.
“This represents a new standard for responsible, independent clinical data sharing,” Waldstreicher added.
YODA will review and decide on all requests for data from Janssen trials, including clinical study reports and de-identified patient-level data.
While YODA members “may reach out to Janssen researchers with questions, the final decision on data-sharing will be made by YODA”, the company stated.
Members of the YODA team at Yale School of Medicine will select and appoint an independent external panel of non-Janssen experts to help assess data-sharing requests in some cases.
Janssen has also launched a new web-based mechanism at www.clinicaltrialstudytransparency.com to help researchers request access to data from the company’s clinical trials.
“We already have well-established policies for registration and disclosure of clinical-trial results in external registries, as well as publication of results in peer-reviewed journals, and we have histortically worked with external researchers to address other types of data requests,” noted Dr Bill Hait, global head, Janssen R&D.
Among the features of the YODA Project model are: