Trial Results & Research Progress

Registering New Clinical Studies

Pfizer registers all of our interventional studies (i.e., Pfizer-sponsored trials that involve the use of a Pfizer drug, biologic or device) as well as de-novo non-interventional studies of the use of Pfizer drugs, biologics, or devices (i.e., non-interventional trials where the data collection is prospectively defined in the study protocol prior to enrollment). All of these studies are registered on www.clinicaltrials.gov

Posting Study Results

Pfizer posts results of all of our registered studies, including our interventional and non-interventional trials. Summary results are posted on www.clinicalstudyresults.org. Pfizer also posts detailed results of hypothesis-testing studies (phase II-IV) completed on or after September 27, 2008, on www.clinicaltrials.gov.

Pfizer posts results according to the timelines described below:

• Post-approval studies: For studies involving products already approved for sale in any country, Pfizer posts results on www.clinicalstudyresults.org within one year after the protocol-defined study completion date. For studies subject to the FDA Amendments Act of 2008 Title VIII and/or the Maine Reporting Requirements for Pharmaceutical Manufacturers and Labelers, Pfizer posts results of those studies within one year of the primary completion date on www.clinicaltrials.gov
• Pre-approval studies: For studies completed prior to submission of the initial marketing authorization application, Pfizer posts results on www.clinicalstudyresults.org within one year of the first approval/clearance outside of the US. For studies subject to the FDA Amendments Act Title VIIII and/or the Maine Reporting Requirements for Pharmaceutical Manufacturers and Labelers, Pfizer posts results on www.clinicaltrials.gov and www.clinicalstudyresults.org within 30 days of the FDA marketing authorization.
• Discontinued Programs: The results of any study registered on www.clinicaltrials.gov involving an unapproved product for which development of the compound is discontinued, are posted within one year of the date of discontinuation of development of the compound on www.clinicalstudyresults.org

In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and complete manner and are reported regardless of the outcome of the study or the country in which the study was conducted.

• http://clinicalstudyresults.org
• http://clinicaltrials.gov