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Guide addresses questions on clinical trials

Patients need to know what their participation could mean for them, as well as for the researchers, before enrolling.

By Susan J. Landers, amednews staff. May 27, 2002.

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Washington -- A new guide designed to answer patients' questions about the pros and cons of participating in clinical trials has been published as the number of clinical trials increases along with the concerns of the potential enrollees.

There are about 80,000 clinical trials being conducted in the nation, and finding enough volunteers to enroll in them consumes up to a quarter of a researcher's time, said Diana L. Anderson, PhD, president and CEO of a private clinical research company in Dallas.

The awareness of clinical trials in the country is very low, said Dr. Anderson, who is also the vice chair of the 16,000-member Assn. of Clinical Research Professionals. "Somewhere around 4% of people who would be eligible to participate in a trial have ever been in a trial," she said. "And we've had a lot of negative press lately."

While the death of a participant in a gene therapy trial at the University of Pennsylvania, Philadelphia, was a great tragedy, Dr. Anderson noted that there are many more instances in which trials go very well.

A recent Harris Interactive survey revealed why researchers face a tough recruitment job. The vast majority of those queried said they were nervous about participating in clinical trials, and many expressed some doubt that they would receive very good medical care if they volunteered. Only about 25% of the 2,031 adults surveyed online last February said they were confident that new treatments are tested on human subjects only after there is valid scientific evidence that the treatments are likely to be effective and safe. [...]