AstraZeneca establishes scientific review board for clinical trial data transparency
AstraZeneca has created a scientific review board that will act independently to assess requests from external researchers, which includes patient level data. The board of independent clinicians and academics has been established as part of AZ'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 EMA Clinical Trial Policy and Regulation.
The board is chaired by Peter Kowey, M.D., 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, M.D., Larson Professor of Medicine, University of Nebraska Medical Center
- Simon Day, Ph.D., director, Clinical Trials Consulting and Training
- Alexander Walker, M.D. DrPH, principal, World Health Information Science Consultants.
The scientific review board will meet on a regular basis to consider all external requests for access to data from AZ 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 also will have the option of granting conditional approvals or providing suggestions on how to resubmit requests to secure approval.
The creation of the scientific review board is part of AZ's broader Clinical Trial Transparency Policy, which includes posting the results of all AZ sponsored clinical trials in all stages of clinical development on several public web sites, regardless of outcome. Other new components of the AZ policy that will be implemented in 2015 include:
- Creation of a Data Transparency Portal through which researchers can submit requests to access anonymized patient level data
- Creation of Lay Language Summaries of clinical trial results, to be made available to all patients that participate in AZ sponsored clinical trials, and publically through web sites 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 E.U. portal when it comes online in 2016.
Dr. Briggs Morrison, executive vice president, global medicines development, and chief medical officer at AZ, 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."
The scientific review board will be responsible for reviewing requests for AZ clinical trial data that meet the following criteria:
- The data relate to AZ-sponsored interventional phase I to phase IV patient studies
- The data have been provided to health authorities to support approved (or discontinued) indications in either the U.S., E.U. or Japan and have completed the approval process in the relevant regions
- The data relate to studies that were initiated from 2009 onwards.