Sharing Clinical Trial Data at Johnson & Johnson Dr. Joanne - - PowerPoint PPT Presentation

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

Medical Devices Pharmaceuticals

The Yale Open Data Access Project

Independent but Collaborative

Experience with data sharing Shared view

• f the benefits
• f responsible

data sharing Collaborative and flexible mindset

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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:

– Interact with requestors – Have an advisory Steering Committee – Engage external experts at their discretion – Have final decision-making authority

Requestors must:

– Provide details about themselves, the research and statistical analysis plan – Submit a plan for publication – Sign a Data Use Agreement

Janssen will:

– Confirm we have the ability to share the data – Verify the product has been approved – De-identify and remove private/confidential information

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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• 6 closed/withdrawn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

• J&J remains blinded to identity of researcher until decision is

made by YODA project

Institutional affiliation: Novel secondary research

• One request received for replication of results
• One request for medical device data (data provided)

Proposed Analysis: Four submitted; one accepted Publications Submitted:

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Details about all proposals are publicly available at

http://yoda.yale.edu

Required resources are significant

25% of proposals request data from 1 trial

• Others request multiple trials
• Max requested for a single

research proposal: 38 trials

Resources include:

• Secure data sharing platform
• Independent review panel
• Internal resources supporting

the process

• External contractors providing

technical capabilities

Average time to fulfillment: ~80 days

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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)

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Together, we will advance science, the foundation of medical care Together, we will make a difference in the world

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Thank you!

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