The news has been filled with talk of improper, even fraudulent behavior during clinical trials. From improper report filing during Rezulin clinical trials to fraud during breast cancer chemotherapy trials, the clinical trial system appears to be in disarray. In response, the Clinton administration announced steps to improve patient safety during clinical trials.
New proposals from the administration address training issues, conflict of interest problems, additional powers for the FDA and observation of the informed consent process. More specifically the proposals seek to:
- Require additional training of health professionals receiving grants from the National Institutes of Health.
- Enhance the importance of the FDA in the clinical trials process by granting the organization the authoritiy to level fines of $250,000 per researcher or $1 million per institution for violations.
- Researchers with a financial interest in the trial they are conducting will have to disclose that interest to potential patients.
- The administration seeks to increase their observation of the informed consent process and seeks third-party presence during informed-consent meetings with trial participants.
- Oversight of clinical trials will begin during smaller studies and earlier in the process.
The intended new policies are a repeat of the administration's call for better procedures. Industry leaders generally support the initiatives, though some feel the fines and penalties are in excess. The FDA already has the ability to stop research the agency feels is improper. Fines may only serve to scare some away from the clinical research process.