Public Disclosure of Pfizer Clinical Study Data and Authorship
Pfizer is committed to meeting the Principles for Responsible Clinical Trial Data Sharing identified by the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America (EFPIA/PhRMA) and internationally recognized ethical and scientific frameworks.
Deliverables, which may include study registration, results posting, publications, data sharing with researchers and investigators, results sharing with study participants, and/or press releases, accurately reflect the scientific and medical conclusions drawn from the study and meet regulatory authority specifications.
Study results are reported by Pfizer in an objective, accurate, balanced, and complete manner regardless of the outcome of the study or the country in which the study was conducted.
Non-interventional post-authorization safety studies are posted in accordance with Guideline on Good Pharmacovigilance Practices EMA Guidance - Guideline on Good Pharmacovigilance Practices - module VIII 09-Oct-2017 I on the European Union Post Authorization Safety Study register; European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
Registration of Clinical Studies
Pfizer registers:
- All Pfizer-sponsored interventional clinical studies in human subjects on ClinicalTrials.gov that involve a Pfizer product and/or non-Pfizer product that evaluate the safety and/or efficacy of a product.
- All Pfizer sponsored non-interventional studies on ClinicalTrials.gov that evaluate the safety and/or efficacy of a Pfizer product.
- Expanded Access (compassionate access) protocols that involve a non-approved product.
Posting of Study Results by Pfizer
- Regardless of the geographical location in which an interventional study was conducted, Pfizer posts Basic Results on ClinicalTrials.gov and/or public summary results on Pfizer.com for Pfizer-sponsored studies that evaluate safety and/or efficacy.
- Pfizer posts results of Pfizer-sponsored studies according to the European Union requirements posted on the Clinical Trial Information System and EudraCT, if required in alignment with the timing and modality set forth by the European Medicines Agency.
Pfizer posts public summary results plain language study results summaries and clinical study report synopses) for Pfizer-sponsored studies.
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