A new set of guidelines issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) calling for the release of more data from clinical trials is being met with guarded skepticism by advocates who have been clamoring for increased transparency.
The guidelines, approved by PhRMA's executive committee on June 30, say the results of clinical trials for marketed drugs should be made public "whether they are favorable to the company sponsoring the trial or not." They also suggest that the clinician in charge of the trial be paid in currency, and not with stock options from the company commissioning the trial.
The voluntary guidelines have been in development since 2002 and mostly reflect protocols already in place, according to Alan Goldhammer, PhRMA's associate vice president for regulatory affairs. They have been updated in recent weeks to clarify the association's views on conflicts of interest and the publication of negative trial ...
