Sharing Clinical Trial Data: Recent Experience and Issues Raised

• Activity Number: 385
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jesse Berlin*+
• Companies: Johnson & Johnson
• Keywords: transparency ; data sharing ; clinical trials

Abstract

Janssen R&D recently signed an agreement with the Yale School of Medicine's Open Data Access Project (YODA) for clinical data sharing. Under the agreement, YODA will serve as an independent third party to review and respond to requests for access to Janssen's clinical trials data. This is the first time any company has collaborated with a completely independent third party to review and make final decisions regarding every request for clinical data.

Issues that have arisen in discussions include: should participant-level datasets be routinely de-identified and prepared for sharing as part of the process for closing out a clinical trial? What level of scientific review is required before data can be released? If the principle is that transparency is important, then surely a protocol / statistical analysis plan should be required, at a minimum. What is the feasibility of including a requirement in a data use agreement that results should not be disseminated unless peer-reviewed? What opportunity is there to involve the original investigators in the planning of the analyses?