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.
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.
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.
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.