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Pfizer Clinical Trial Registration and Posting Results

Pfizer Clinical Trial Registration and Results Posting

At the outset of clinical trials, Pfizer registers those studies on clinicaltrials.gov and the U.S. National Institutes of Health’s publicly available clinical trials registry and database. After the completion of those studies, we provide results on clinicaltrials.gov and other registries, in accordance with local regulations and guidelines.

 

January-December 2013
  Number Percent
Registrations 133  
On Time Compliant with FDAAA* 132 99.2%
Results 107  
On Time Compliant with FDAAA* 107 100%

*FDAAA is the Food and Drug Administration Amendment Act

 

Under FDAAA, sponsors are required to register their studies within 21 days of the first subject, first visit (when the first participant officially enrolls in the study).  Results must be posted within one year of study completion  for marketed products.  For investigational medicines, results are posted within 30 days of regulatory approval.  

Responsible Data Sharing

Pfizer’s practices adhere to the principles for responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).