Docs calling all volunteers - Shrinking test pool delays new drug trials
Michael Lasalandra

A major problem in getting new drugs and treatments approved is enrolling enough subjects for the clinical trials.

A startling 87 percent of trials have to be delayed because they can't find enough volunteers, researchers say.

Since the shocking death of an 18-year-old boy in a gene therapy trial three years ago at the University of Pennsylvania, the problem has become even worse.

"We have lots of new medications out there, but they are all competing for the same patient population," said Diana Anderson, who heads a company that helps find volunteers for trials of rheumatology drugs. "Sometimes, it's like finding a needle in a haystack."

The result is that approval of new drugs is often delayed, hurting patients who could benefit from them, she said.

The issue is being addressed by researchers from around the world this week at a conference in Toronto. The Association of Clinical Research Professionals is looking to find new ways of enrolling subjects, including using the Internet, and has forged a partnership with Yahoo! as a way to provide clinical trial information to prospective subjects.

But researchers attending the conference also will hear from Paul Gelsinger, the father of Jesse Gelsinger, the boy who died in the notorious gene therapy trial gone wrong.

Gelsinger said he wants to tell the researchers that the "informed consent" process, in which subjects are supposed to be told of the possible risks and benefits to them, needs fixing.

"Flaws are prevalent in the system," Gelsinger said in an interview. "There's a real problem and a danger to people. Most subjects don't realize it."

Gelsinger said he is in favor of allowing people with serious illnesses who have no viable treatment options to join research studies that might help them, but has questions about allowing healthy individuals to be used as guinea pigs.

"In my son's case, the research was being done to help those in a serious situation, but they were using relatively healthy people to experiment on," he said. "The researchers couldn't even see the dangers. They had so many influences on them. That's when the money starts running the show."

Jesse Gelsinger had enrolled in a trial to test a treatment for an inherited enzyme deficiency, but died when researchers injected his liver with an adenovirus designed to deliver a gene-therapy agent.

The virus shut down his liver and he died a few days later. The irony was that Gelsinger wasn't particularly sick; he suffered from a mild form of the enzyme disorder. The treatment he was testing was designed to treat babies with a fatal form of the disorder.

Two new guides have been published this month in a bid to help potential subjects decide whether to enroll in trials.

"Should I Enter a Clinical Trial?" was researched and published by ECRI, an independent nonprofit health services research agency which received an educational grant from the American Association of Health Plans to produce the guide. The 132-page guide is available to download electronically at no cost at either www.ecri.org or www.aahp.org.

The other is "Informed Consent" (Thompson, $16.95) by Kenneth Getz, chief executive officer of CenterWatch, a Boston-based organization providing information on the clinical trials industry.

"The message is that you have to know a lot more than what they tell you in the informed consent form," Getz said.

He urged potential subjects to ask plenty of questions and review the study protocol with a trusted adviser such as a family doctor.

"People need to know these are experiments and there are risks involved," he said.

Source:
04/14/2002
Boston Herald
All Editions
Page 009
(Copyright 2002)