|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 which will include instructions for submission via the Pfizer portal. If the request is approved, Pfizer will upload the anonymized data into the Vivli platform for use by researchers.|
|Studies available for sharing||Pfizer-sponsored global interventional clinical trials:
• Conducted for medicines, vaccines and medical devices for indications that have been approved in the US and/or EU.
• Conducted for medicines, vaccines and medical devices in programs have been terminated, that is, development for all indications has been discontinued.
|Exceptions||The following are reasons that would preclude granting access in response to a data request:
• Patient privacy – For example, the request seeks clinical data for which patient de-identification 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.
• 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
• 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.
• Where there are substantial practical constraints to providing access via the Vivli platform.
• 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 24 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:
🗹 Anonymized 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:
• Is the research question clearly defined with a scientifically valid rationale?
• Is there a well-documented and rigorous statistical analysis plan?
• If the proposal includes combining data across different Pfizer trials, is there a clear plan to standardize data sets to ensure they are comparable?
• Is there an adequate publication plan to disseminate findings in a peer reviewed journal or scientific meeting?
• Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith?
• Is the applicant willing to declare all professional interests, affiliations, possible conflicts of interest, and all sources of support for the research as part of the dissemination of their results?
• Does the research team have sufficient expertise and qualifications to perform the proposed investigation?
|Data Request Review Process||To request access to patient-level data, researchers should submit a scientifically valid research proposal via the Vivli platform which will include instructions for submission information via Pfizer’s online portal.|
|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 anonymized 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 anonymization. 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|