FDA Reevaluates Clinical Drug Trial Standards

July 2006

After coming under scrutiny for their approval of the antibiotic Ketek, which may cause liver damage in some patients, the Food and Drug Administration (FDA) will reevaluate how they handle clinical drug trials.

The current FDA regulations on clinical drug trials date back over twenty-five years ago when studies were done by a single doctor. These days, trials involve thousands of patients at various locations, and instead of a doctor coordinating the study there are now organized by clinical-research organizations. The FDA believes that regulations should govern all parties involved in a clinical trial.

The FDA is planning to propose a new rule this year that would require study sponsors to report anyone who has committed fraud in a trial.