Data Access Requests
Pfizer allows secure access to anonymized patient-level data in response to scientifically valid research proposals.
Data from Pfizer-sponsored studies* are available 24 months after study completion. Data are available from clinical trials for which Basic Results are posted in the clinicaltrials.gov registry (e.g., dating back to September 2007). You can see which trials have data available by visiting our Clinical Study Report Synopses page, and selecting the "Show only synopses that have Patient-Level Data available for request" option.
To access patient-level data, a research proposal must be submitted. An internal committee composed of Pfizer colleagues who are familiar with the data, reviews all in scope applications. If the application is denied or only partially approved, an Independent Review Panel of outside experts will review the application. The Independent Review Panel’s decision is considered final and binding.
In considering an application, both the internal review committee and the Independent Review Panel will assess a number of criteria, including the scientific rationale for the research and whether there is a well-documented and rigorous statistical analysis plan. All those receiving access to data will be required to enter into a data access agreement.
Independent Review Panel
To ensure that requests for patient-level data from Pfizer-sponsored clinical trials are handled fairly, impartially, and consistently, an Independent Review Panel has agreed to work with Pfizer to review all requests for in scope clinical data not initially approved, in whole or in part, by Pfizer’s internal review committee. The final decision rests with the Independent Review Panel and is considered binding.
The responsibilities and decision-making processes of the Panel, including the criteria used to evaluate data requests, are outlined in the Independent Review Panel charter.
Members of the Independent Review Panel were selected by Pfizer based on their experience, training, and expertise in aspects of clinical research conduct, from ethics to statistical analyses. Three of the Independent Review Panel members are on Pfizer's Bioethics Advisory Committee.
Independent Review Panel Members**
- Stephen Senn, PhD (Chair) - Head of Competence Centre for Methodology and Statistics at CRP-Santé, Luxembourg
- Bartha Knoppers, PhD, MA, LLB/BCL, Director of the Centre of Genomics and Policy, McGill University, Montreal (Quebec), Canada
- James Lavery, PhD, Research Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital and University of Toronto, Toronto (Ontario), Canada
- Johan Karlberg, MD, PhD, Managing Director, Clinical Trial Magnifier Limited, Hong Kong SAR, PR China; Vice-President, Alliance for Clinical Research Excellence and Safety (ACRES), Cambridge, MA
* Clinical Trials that are carried out as part of a co-development or co-promote partnership between Pfizer and another company may be subject to a different review process mutually agreed to by each partner.
** As of December 4, 2013. Panel composition may change. Pfizer intends to run the Independent Review Panel process through 2014 and may re-assess the review process as data sharing practices evolve.