PhRMA releases new guidelines for clinical trials
April 28, 2009
Pharmaceutical companies should provide results summaries for all interventional clinical trials involving patients, according to revised industry guidance.
Companies should publish the summaries whether the FDA approves the medicines or the particular research programs have been discontinued
The newly revised Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results also:
- Commits companies to registering clinical trials on public Web sites
- Adopts the authorship standards of the International Committee of Medical Journal Editors
- Enhances disclosure standards for published research
The revised guidelines align with the changes to the PhRMA Code on Interactions with Healthcare Professionals, which became effective in January.