February 29, 2000
Clinical Trials Database for Patients Goes Online
By THE ASSOCIATED PRESS
ASHINGTON, 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
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
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.