Sharing Clinical Trial Data at Johnson & Johnson Dr. Joanne Waldstreicher Chief Medical Officer Johnson & Johnson November 3, 2016 NAM CERIC
At Johnson & Johnson we believe that sharing clinical trial data advances the science, which is the foundation of medicine.
Johnson & Johnson: Pharmaceuticals, Devices, and Consumer Products Pharmaceuticals Medical Devices
The Yale Open Data Access Project Independent but Collaborative Shared view Experience with Collaborative and of the benefits data sharing flexible mindset of responsible data sharing 4
Features of the YODA Project agreement Commitment to review all requests and try to fulfill if consistent with YODA Project principles, irrespective of when studies conducted YODA Project will: Requestors must: Janssen will: – Interact with requestors – Provide details about – Confirm we have the ability to themselves, the research share the data – Have an advisory Steering and statistical analysis – Verify the product has been Committee plan approved – Engage external experts at – Submit a plan for – De-identify and remove their discretion publication private/confidential – Have final decision-making – Sign a Data Use information authority Agreement 5
Our Experience since October 2014 57 research proposals involving 132 unique clinical trials • 49 approved, 2 pending, 0 declined by the YODA Project • 6 closed/withdrawn Mostly academic investigators Institutional affiliation: J&J remains blinded to identity of researcher until decision is made by YODA project Novel secondary research Proposed Analysis: One request received for replication of results One request for medical device data (data provided) Details about all Publications Submitted: Four submitted; one accepted proposals are publicly available at http://yoda.yale.edu 6
Required resources are significant Average time to fulfillment: ~80 days Resources include: 25% of proposals • request data from 1 Secure data sharing platform • Independent review panel trial • Internal resources supporting • Others request multiple trials the process • Max requested for a single • External contractors providing research proposal: 38 trials technical capabilities 7
Priorities for the future of data sharing Robust, secure platform and governance structure for meta analyses, combining datasets from multiple sources Sustainable infrastructure and business models Broader engagement across all clinical trial sponsors (government, academic, industry, NGOs) 8
Together, we will advance science, the foundation of medical care Together, we will make a difference in the world 9
Thank you! 10
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