|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 de-identified 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:
|Exceptions||The following are reasons that would preclude granting access in response to a data request:
|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)
🗹 Statistical analysis plan
🗹 Data dictionary
🗹 Annotated case report forms
🗹 Redacted clinical study reports
🗹 Analytic code
|Questions or enquiries||CTD@Pfizer.com|
|Review Criteria for Data Requests||In addition to taking into account the exceptions and the additional conditions for access noted above, Pfizer will evaluate the following:
|Data Request Review Process||To request access to patient-level data, researchers should submit a scientifically valid research proposal via the Vivli platform.|
|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|