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Trial Results & Research Progress
Registering New Clinical Studies
Pfizer registers (1) all Pfizer-sponsored interventional studies in human subjects that evaluate the safety and/or efficacy of a Pfizer product (ie, drug, biologic or device); and (2) all Pfizer-sponsored non-interventional studies, regardless of design or data source, where the primary endpoint is to study whether a Pfizer product is associated with an increased incidence of a specific safety outcome. We register all of these studies on www.clinicaltrials.gov.
Posting Study Results
Pfizer submits study results in a tabular format mandated by the United States National Institutes of Health for posting on www.clinicaltrials.gov. We submit results for all of the Pfizer sponsored studies that have been registered on www.clinicaltrials.gov, not including phase I studies in healthy volunteers.
Pfizer submits study results as follows:
Pre-approval studies: For Pfizer-sponsored studies completed prior to submission of the initial marketing authorization application, Pfizer submits the study results for posting within one year of the first approval/clearance outside of the US for products that will only be marketed outside of the US. For studies subject to the FDA Amendments Act Title VIIII, Pfizer posts results on www.clinicaltrials.gov; within 30 calendar days of the FDA marketing authorization.
- Post-approval studies: For Pfizer-sponsored studies involving products already approved for sale in any country, Pfizer submits the study results for posting within one year of the date of the last subject's last visit date. For studies subject to the FDA Amendments Act of 2008 Title VIII, Pfizer posts results of those studies within one year of the pre-defined primary completion date for the study.
- Discontinued Programs: For Pfizer-sponsored studies involving an unapproved product for which development of the compound has been discontinued, Pfizer submits the study results for posting within two years (of the date of discontinuation of development of the compound).
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and complete manner -- regardless of the outcome of the study or the country(ies) in which the study was conducted.