Web registry of medical experiments goes online (US)

Copyright © 2000 Nando Media
Copyright © 2000 Associated Press
By LAURAN NEERGAARD 
http://www.techserver.com/noframes/story/0,2294,500174470-500226351-50
1088186-0,00.html WASHINGTON (February 29, 2000 7:24 a.m. EST
http://www.nandotimes.com) - 

Your doctor grimly announces there's no more chemotherapy to try for
your pancreatic cancer. Or you heard a news blurb about an
experimental Parkinson's drug, but your physician isn't testing it
so you're stumped. 

Or you'd desperately like a less-toxic medicine for your child's
rheumatoid arthritis. 

Scientists are conducting thousands of clinical trials in a quest to
improve treatment of hundreds of diseases, yet less than 5 percent
of American patients enroll in such medical experiments. 

One reason is that it's difficult for sick patients to determine
who's studying what and then wade through the scientific jargon to
determine if an experiment might help them or is too risky. But
beginning Tuesday, the government's National Library of Medicine will
open a Web-based registry to help. 

Congress ordered the comprehensive database posted for all clinical
trials for serious illnesses - with consumer-friendly explanations
of how the experiments work and what questions patients should ask to
ensure they understand the risks, such as: 

•Why do researchers think this treatment will work better than
standard care? How many people have tested it, and what happened to
them? What side effects are possible? 

•What kinds of tests or procedures will I undergo? Will they hurt? 

•Who is funding the study, and who will oversee my care? Will I have
to pay for any of it? 

Each study lists a phone number to reach researchers about enrolling
and ask those questions. 

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

Jane Henney, commissioner of the Food and Drug Administration,
advises patients to ask their own doctors to help sift the studies
listed on the database. Patients considering participating in a study
should bring a friend or relative along to hear researchers explain
the risks and benefits. 

"If they don't understand something, it might be that you didn't
either," Henney warned. Patients "are very vulnerable for
information that might sound too hopeful. ... Be willing to ask
questions and probe for information." 

The free database so far contains 4,000 studies at 47,000 sites
nationwide, mostly government- or university-sponsored ones. But
Congress mandated that it be comprehensive, so more studies,
particularly drug-company trials, will likely be added in coming
months. 

A handful of other Internet sites also are attempting to list
certain clinical trials. the communications company CenterWatch
claims that more than 200,000 visitors a month visit 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, top-notch care. 

But there are caveats. Patients may not get the experimental
treatment, but a placebo or standard care for comparison. 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 a University of
Pennsylvania gene-therapy experiment killed an Arizona teenager. 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 very toxic long-term effects. 

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

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

Making medical experiments more patient-friendly would help, says
Elizabeth Moench of MediciGroup, citing a scientist who developed a
special safety quiz for his clinical trial after too many patients
forgot the risk warnings. 

MediciGroup is working with the Internet polling company Harris
Interactive and its database of 500,000 patients to help companies
design better clinical trials and then fill them. 

Links:

http://www.techserver.com/noframes/story/0,2294,500174470-500226351-5
01088209-1,00.html

http://clinicaltrials.gov/

http://www.centerwatch.com/

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