Pfizer has had a longstanding commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants. Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals.
Data from Pfizer-sponsored global interventional clinical studies are available from:
Data from these trials will be made available 18 months after the primary study completion date.
Pfizer will consider requests from qualified researchers for access to Pfizer clinical data. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Qualified researchers’ proposals are submitted via the Vivli platform.
To obtain Pfizer data for analysis on the Vivli platform, data requestors must complete a data request on the Vivli platform. Pfizer will review the request using an internal committee, composed of Pfizer colleagues who are responsible for the asset program, statistician, and data sharing experts. Interactions between our company and requestors of access to data and information are intended to be collaborative in nature. The committee will evaluate the following:
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. The following are reasons that would preclude granting access in response to a data request:
All those receiving access to data will be required to enter into a Data Use Agreement (DUA). Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. Access to data needed for research is provided on a password-protected platform via Vivli. This platform allows researchers to conduct research on the site and to download their analyses. Access is provided for 12 months. Extensions are possible when justified and upon review and approval.
Researchers are invited to conduct their research in a private workspace. This workspace is not accessed by Pfizer or any other third party unless researchers provide permission. To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of de-identified data provided for access.
In cases where a request is rejected based on scientific merit, the request, along with the record of our denial of the request, shall be forwarded to an Independent Review Panel for a final decision. The Independent Review Panel is composed of scientists and/or health care professionals who are not Pfizer employees. The outcome of the Independent Review Panel decision will be shared with the applicant. The Independent Review Panel’s decision is considered final and binding.
Researchers are responsible for gaining any other approvals that are required for the research (for example, from ethics committees, institutional review boards, relevant research institutions or funding bodies).
After the researcher has completed the research per the approved study proposal and analysis plan, the researcher is expected to publicly share the results per the executed DUA.
Pfizer’s practices adhere to the principles for responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).