Pfizer will provide access to anonymized patient-level data in response to scientifically valid research proposals.
Data from Pfizer-sponsored global interventional clinical studies are available from:
- Trials conducted for medicines, vaccines and medical devices for indications that have been approved in the US and/or EU.
- Trials conducted for medicines, vaccines and medical devices that have been terminated (i.e. development for all indications has been discontinued)
Data from these trials will be made available 24 months after study completion.
Pfizer will make reasonable efforts to fulfill all data requests for legitimate research purposes, but there may be instances in which retrieval or delivery of data is not feasible (for example, if Pfizer does not have legal authority to provide the data, if costs of retrieval of older or pre-electronic data are prohibitive, etc. – see details below*).
To access patient-level data, researchers should submit a research proposal. An internal committee, composed of Pfizer colleagues who are familiar with the data, reviews all 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.
To submit your data access request, please click the following link: Submit your request for patient-level data
We encourage you to contact [email protected] and provide the following information prior to your submission, in order to assess the feasibility of your request:
- Study number(s) requested (NCT ID number and/or Pfizer-sponsored study number)
- Synopsis of your proposed analysis/research
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 reviews any requests for 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 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
* Circumstances under which it may not be possible for Pfizer to fulfill data requests may involve:
- Clinical data for which anonymisation is difficult, there is a reasonable likelihood of re-identification (e.g. small studies, single-center studies, studies terminated early for lack of enrollment, clinical studies of rare diseases, or studies for which data does not exist in a format that can be readily anonymised), or there is a reasonable likelihood of otherwise violating the privacy rights of individuals;
- Clinical data that have been collected subject to legal, contractual or consent provisions that prohibit transfer to third parties;
- Locally administered studies in which data and results are only available in languages other than English;
- Case narratives, documentation for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data;
- Or substantial practical constraints to providing technical data access (e.g. older, pre-electronic data for which files cannot be located).
Where Pfizer has a co-research, co-development or co-marketing/co-promotion agreement or where the product has been out-licensed, it is recognized that the responsibility for disclosure may be dependent on the agreement between parties. Under these circumstances, Pfizer will endeavor to gain agreement to share data in response to requests.