Sharing Industry Clinical Trial Data: Improving Public Health While Maintaining the Oversight Relationship Between Regulator and Sponsor

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1 Sharing Industry Clinical Trial Data: Improving Public Health While Maintaining the Oversight Relationship Between Regulator and Sponsor Steven Snapinn SCT/QSPI/FDA Workshop Innovations in the Science and Practice of Clinical Trials December 10, 2014

2 Outline Industry Reputation PhRMA Principles Industry Model for Data Sharing Examples (LIFE, SOLVD, Horror Story) Types of Questions

3 Industry Reputation Widespread Belief That Industry Is Conflicted And Therefore Can t Be Trusted As Sole Owner of Clinical Trial Data e.g, Newsweek, November 17, 2014 Cover Story: Big Pharma Plays Hide-the-Ball With Data Growing Movement to Increase Data Transparency And Define the Rules for Appropriate Data Sharing EMA Policy on Publication of Clinical Trial Data; June 2014 Institute of Medicine: Strategies for Responsible Sharing of Clinical Trial Data; Interim Report Jan 2014, Final Report Dec 2014

4 PhRMA-EFPIA Principles 1. Enhancing Data Sharing with Researchers Biopharmaceutical companies commit to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and the European Union (EU). Companies will implement a system to receive and review research proposals.

5 PhRMA-EFPIA Principles 1. Enhancing Data Sharing with Researchers (cont) Each company will establish [an independent] scientific review board Members will review data requests to determine whether they meet the criteria. Companies will publicly post their data request review process. Companies will provide access to patient-level data consistent with the principle of safeguarding patient privacy.

6 PhRMA-EFPIA Principles 1. Enhancing Data Sharing with Researchers (cont) Data requestors will be required to submit a research proposal Description of the data being requested, including the hypothesis to be tested Rationale for the proposed research The analysis plan A publication and posting plan Qualifications and experience of the proposed research team Description of any potential conflicts of interest

7 PhRMA-EFPIA Principles 2. Enhancing Public Access to Clinical Study Information 3. Sharing Results with Patients Who Participate in Clinical Trials 4. Certifying Procedures for Sharing Clinical Trial Information 5. Reaffirming Commitments to Publish Clinical Trial Results

8 Industry Model for Data Sharing Study sponsors: Bayer, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB and ViiV Healthcare. Submission Submit proposals and request anonymised data Sponsor s criteria for listing studies is provided Submit enquiries about the availability of data from studies not listed Review Proposals are reviewed by an Independent Review Panel Access Access to the data is provided on a password protected website

9 Case Studies in My Experience Losartan for Endpoint Reduction in Hypertension (LIFE) Lancet Mar 23;359(9311): Database mined for > 100 publications Studies of Left Ventricular Hypertrophy (SOLVD) N Engl J Med 1991; 325: NIH sponsored trial used as basis for label extension for enalapril Database made public through FOI One Additional Horror Story

10 Types of Questions to Be Addressed Advancing the Science Mining the database to address new hypotheses Reevaluating the Benefit:Risk Profile of the Treatment Double-checking the sponsor s work Reevaluation using new analysis techniques

11 Summary Scientific Community and Public Lack Trust in Clinical Research Performed by the Pharmaceutical Industry Data Sharing to Address New Hypotheses Can Advance Scientific Knowledge Data Sharing to Reevaluate the Benefit:Risk Profile of the Treatment Can Impact the Regulatory Process