Clinical Trials Database for Patients Goes Online

by The Associated Press, February 28, 2000

Washington, Feb. 28 -- The federal government will open a database on Tuesday of all clinical trials for serious illnesses, with simple explanations of how the experiments work and what questions patients should ask before enrolling to ensure that they understand the risks.

Each study lists a phone number that can be used to call researchers about enrolling and to ask questions about the study. Less than 5 percent of American patients now enroll in such medical experiments.

"This is a single place you can go where the most important information, we hope, will be available to everybody," said Dr. Donald Lindberg of the National Library of Medicine, which is opening the registry,

Commissioner Jane E. Henney of Food and Drug Administration advised people to seek a doctor's help in sifting through the studies, and then, when entering a study, to take along a friend or relative to hear researchers explain the risks and benefits.

"If they don't understand something, it might be that you didn't either," Ms. Henney said. Patients "are very vulnerable for information that might sound too hopeful," she said.

The free database so far contains 4,000 studies at 47,000 sites nationwide, mostly sponsored by government agencies or universities.

Congress has mandated that the registry be comprehensive, so more studies, particularly drug company trials, will probably be added.

A handful of other Internet sites also are trying to list certain clinical trials; the communications company CenterWatch claims over 200,000 visitors a month check its site,

Clinical trials are vital to medical progress, enabling doctors to treat and understand disease better. They can offer patients access to cutting-edge therapies and, because participants are supposed to be so strictly monitored, first-rate care.

But there are caveats. Patients may not get the experimental treatment, but a placebo or standard care for comparison. And the research could be in such an early stage, or the person so sick, that the only reason to participate is to help future patients.

Or the experiment could fail or be harmful. Indeed, experts are questioning the oversight of clinical trials after an Arizona teenager died in a University of Pennsylvania gene therapy experiment. The boy's father told Congress he was misled about the risks. Consequently, getting involved can be a hard decision.

"It was very tough," Patrick Cotter of Madison, Wis., said of enrolling his daughter Colleen, now 8, in a study of the drug Enbrel for juvenile rheumatoid arthritis. Standard medicines were helping Colleen, but they have toxic long-term effects.

"It took us three months to decide," Mr. Cotter said, but Colleen started testing Enbrel two years ago and is doing well. "It was the best thing we ever did," he said.

There is fierce competition for such patients. Pharmaceutical companies usually need about 4,000 people to test an experimental drug. Companies often pay doctors up to $2,500 for every patient they recruit.