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, the U.S. National Institutes of Health’s publicly available clinical trials registry and database. After the completion of those studies, we work to provide results on clinicaltrials.gov and EudraCT within one year of study completion.

 

  January – December 2013 January – December 2014
Total Number of Registrations* 133 129
Total Number of Results* 107 95
Percentage of On-Time Compliant Registrations with FDAAA** 99.2% 100%
Percentage of On-Time Compliant Results with FDAAA** 100% 98.9%

 

*Pfizer posts registrations and results beyond the scope required by FDAAA

**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).