AstraZeneca today announced the creation of a Scientific Review Board that will act independently to assess requests from external researchers which include patient level data. The Board of independent clinicians and academics has been established as part of AstraZeneca’s commitment to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) Responsible Data Sharing Principles, as well as the new European Medicines Agency Clinical Trial Policy and Regulation.
The Board is chaired by Peter Kowey, MD, System Chief, Division of Cardiovascular Diseases for the Lankenau Heart Institute, part of Main Line Health. The other members of the Board are:
Stephen Rennard, MD, Larson Professor of Medicine, University of Nebraska Medical Centre
Simon Day, PhD, Director, Clinical Trials Consulting and Training
Alexander Walker, MD DrPH, Principal, World Health Information Science Consultants, LLC.
The Scientific Review Board will meet on a regular basis to consider all external requests for access to data from AstraZeneca clinical trials. The Board will assess the scientific validity of each request and how provision of the information may enhance scientific understanding and patient care. In addition to approving or rejecting requests, the Board will also have the option of granting conditional approvals or providing suggestions on how to resubmit requests in order to secure approval.
Professor Peter Kowey, Chair of the Board, said: “I am excited to be leading the Scientific Review Board for AstraZeneca and contributing to furthering transparency for the purposes of developing better drugs to help patients across the globe.”
The creation of the Scientific Review Board is part of AstraZeneca’s broader Clinical Trial Transparency Policy, which includes posting the results of all AstraZeneca sponsored clinical trials in all stages of clinical development on several public websites, regardless of outcome. Other new components of the AstraZeneca policy that will be implemented in 2015 include:
Creation of a Data Transparency Portal through which researchers can submit requests to access de-identified patient level data.
Creation of Lay Language Summaries of clinical trial results, to be made available to all patients that participate in AstraZeneca sponsored clinical trials, and publically through websites including astrazenecaclinicaltrials.com.
Clinical Data packages, including Clinical Overviews and Clinical Summaries, Clinical Study Reports, and some of their Appendices (Study Protocols, sample Case Report Forms and Study Statistical Analysis Plans), to be made available via astrazenecaclinicaltrials.com and the new EU portal when it comes online in 2016.
Dr Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “AstraZeneca has a longstanding commitment to clinical trial transparency and these new developments are part of the evolution of that policy. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients.
We are delighted to underpin our policy with the establishment of the Scientific Review Board and are pleased to have such an experienced panel on board to support us.”