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About Pfizer has had a longstanding commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants.
How we share on the Vivli Platform To obtain Pfizer data for analysis on the Vivli platform, data requestors must complete a data request on the Vivli platform. If the request is approved and a Data Use Agreement signed, Pfizer will upload the anonymized data into the Vivli platform for use by researchers in the secure Vivli research environment. For more information about the secure research environment sizes, software and no charge period click here.
Studies available for sharing Data from Pfizer-sponsored global interventional clinical studies are available from:

  • For Pfizer products that have received regulatory approval by the Food and Drug Administration (FDA), European Medicines Agency (EMA), or Medicines and Healthcare products Regulatory Agency (MHRA).
  • For Pfizer products from terminated programs (i.e., development for all indications has been discontinued).
  • CTDS requests for data generated from Pfizer-sponsored interventional studies involving a product for which there is a co-development partner.
Exceptions The following are reasons that would preclude granting access in response to a data request:

  1. Patient privacy – For example, the request seeks clinical data for which patient anonymization is difficult or for which there is a reasonable likelihood of re-identification, or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws.
  2. Permissions – Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties; where the request seeks data from locally conducted studies in which data and results are only available in languages other than English.
  3. Where the request is for case narratives, documentation for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.
  4. Where there are substantial practical constraints to providing access via the Vivli platform.
  5. Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
When Studies are Available for sharing Data from trials that meet the criteria above are available 18 months after study completion.
Additional Conditions for Access Data requests must be from qualified researchers with the appropriate competencies to perform the proposed analyses.

Research teams must include a biostatistician.
What information will be provided Based upon the specific request, the following information may be provided:

🗹 De-identified Individual Patient Data (IPD)

🗹 Protocol

🗹 Statistical analysis plan

🗹 Data dictionary

🗹 Annotated case report forms
Questions or enquiries CTD@Pfizer.com
Review Criteria for Data Requests
  1. The scientific rationale and relevance of the proposed research to medical science or patient care.
  2. The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives.
  3. Whether the proposal has potential to produce information that will enable identification of individual research participants.
  4. The publication plan for the research.
  5. Any real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest.
  6. The qualifications and experience of the research team to conduct the proposed research review.
Data Request Review Process Consistent with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts.
Access to study documents without participant-level data Pfizer makes electronic synopses of CSRs publicly available on its website. The electronic synopses include a synopsis of the CSR submitted to regulatory authorities, with data that could be used to identify individual patients removed.

Synopses will be posted for trials either initiated after Sept. 27, 2007, or trials initiated on or before that date that were still ongoing as of Dec. 26, 2007.

To access the synopses that have been posted to date, please visit https://www.pfizer.com/science/research_clinical_trials/trial_results.
Anonymization Standards Data will be de-identified in line with the Safe Harbor method pursuant to HIPAA.

The basic data sets researchers will access may look different from those submitted to regulators or used in publication(s) due to de-identification. As such, in some cases, researchers may not be able to completely duplicate the results of Pfizer analyses.
Clinical Study Register or Website https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

 

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