PUBLIC DISCLOSURE OF PFIZER CLINICAL STUDY DATA AND AUTHORSHIP
Pfizer is committed to meeting the five 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.
Deliverables (i.e., study registration, Basic Results posting, public disclosure synopsis, publications, data sharing with researchers/investigators, results sharing with study participants and, press releases) accurately reflect in appropriate terms the results from the scientific and medical conclusions drawn from the study; and meets the 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.
Pfizer Commercial colleagues, with the exception of Health &Value colleagues involved in designing and conducting research related to health economics and real world data, must not be involved in the funding, preparation, planning, or content development for publications. Involvement is limited to an optional annual meeting with the publication team where marketing may provide non-binding suggestions to the publication team for consideration.
Pfizer is responsible to ensure that study registration and results data posted publicly on other databases are consistent with the information posted on ClinicalTrials.gov.
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
- 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 the study was conducted, Pfizer posts Basic Results on ClinicalTrials.gov for Pfizer-sponsored studies conducted in patients that evaluate the safety and/or efficacy.
- Pfizer posts results of Pfizer-sponsored studies according to the European Union requirements posted on EudraCT in alignment with the timing and modality set forth by the European Medicines Agency.
- Pfizer posts Public Disclosure Synopses for Pfizer-sponsored studies that were initiated after 27-Sep-2007, or initiated on or before that date and were still ongoing as of 26-Dec-2007. The synopsis is posted to Pfizer.com at the same time the Basic Results document is posted to ClinicalTrials.gov