Experts Urge More Research on Growing Use of Humans in Clinical Research

Amid a rapid increase in the number of recruits for clinical trials and calls for stronger regulatory protections of research subjects, several specialists told a 2 May briefing hosted by AAAS and The Hastings Center that there is insufficient data to say whether the protections system is seriously broken or not.

There is little question that the landscape of clinical trials has been changing dramatically, spurring calls for reform and updating of participant protection rules that were written in the 1970s. By one estimate, the number of clinical trials in the United States jumped from 40,000 to 59,000 between the years 2000 and 2006. The number of participants needed to fill industry-sponsored clinical trials reportedly grew from 2.8 million in 1999 to 19.8 million in 2005.

Despite gaps in the system and a perception that it is not working as well as it could, "we don't have a lot of data to say exactly what's wrong," said Christine Grady, head of the section on human subjects research in the Department of Bioethics at the National Institutes of Health Clinical Center. Without better data on who is being protected and what harm may be occurring in clinical trials, Grady said, "we cannot judge the quality of the protections."

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