Call for clinical-trial reform leaves critics unmoved

Washington

Medical watchdog groups in the United States say they are becoming frustrated that reforms of the clinical-research system have failed to materialize, despite repeated calls for tougher regulation.

On 3 October, the Institute of Medicine released a report calling for modest reforms of the system. The report, “Responsible Research: A Systems Approach to Protecting Research Participants”, was written by a panel chaired by Daniel Federman, senior dean for alumni relations and clinical teaching at Harvard University.

The report calls for all research on human subjects to be federally regulated, and recommends the creation of an independent office to oversee such research, and a national registry to track participants and adverse events in all clinical trials. But critics says that this is the fourth such report in five years, and that little has changed in the way that clinical research is regulated.

As the report was released, Senator Edward Kennedy (Democrat, Massachusetts) was introducing legislation to implement some of its main recommendations. But similar legislation has previously languished in the face of opposition from drug firms, medical schools and biomedical researchers.

“We've been talking about this for too long,” says John Mather, chief officer for research oversight at the Department of Veterans Affairs. “Who is going to take that report off the table and do something with it?”

Critics of the existing system have nevertheless welcomed the report. It will get “everyone on the same page to deal with problems in clinical research”, says Paul Gelsinger, whose son Jesse died while participating in a 1999 gene-therapy clinical trial at the University of Pennsylvania.

But some argue that the report fails to recommend the tough new rules that they would like to see applied to clinical trials. “When things aren't mandatory, nobody pays attention, and that's not going to change the rate of violations, death or harm,” says Vera Sharav, president of the Alliance for Human Research Protection.

The report was commissioned by the Department of Health and Human Services after Jesse Gelsinger's death, in response to concerns that institutional review boards do not provide adequate protection for research subjects.