Clinical trials’ red tape focus of Op Ed in NYT
This is my site Written by Alex on August 9, 2009 – 9:20 am   

Researchers involved in clinical trials are being so choked by bureaucratic red tape that their research is suffering, according to Sally Satel, a scholar at the American Enterprise Institute in an op-ed piece in Friday’s New York Times. Satel’s insights are valuable because they point out that thickets of regulations often don’t protect subjects. She however misses the larger point that the red tape and lack of subject protection in what she in the article refers to as the “dysfunctional system” of clinical trials is due mostly to their explosive growth and commodification in the last decade.

The clinical trials industry has grown 300 percent in the last 10-15 years. In the U.S. there are 20 million people enrolled in trials. Regulations have rained down because of greatly increased general participation by increased numbers of institutions, private companies, compensated physicians, special interest groups, and institutional review boards who are now conducting or seeking to conduct trials. The regulations are in place mostly to protect these entities against the threat of litigation; they are empty hoses. The regulatory pile on hasn’t been accompanied by more resources to enforce the new rules. The FDA is so slammed they can only physically inspect 1 percent of trials. Private companies are now conducting more than 70 percent of all clinical trials. These enormous changes have occurred at a time when government oversight – first in the Clinton administration and then under Bush – has been lax at best, nonexistent at worst.

The glue that holds all the red tape in place is an almost holistic lack of desire on behalf of subjects to call for more safety measures. In a poll asking subjects what they were most concerned about – including conflict of interest and lack of regulatory oversight – the number one concern of people enrolled in trials was whether the operating hours of clinics were convenient enough to not disrupt anyone’s schedule. When you truly examine the system of clinical trials you’ll find lots of bureaucracy but no one truly in charge of managing the system. In other words, no one is at the helm at all.

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