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News You Can Use 5/24/99

http://www.***.com/

What you need to know before entering a clinical trial: You are not a
patient

If you are considering volunteering for a clinical trial, you can help
ensure your safety by understanding some of the basic tenets of medical
research, the first of which is that medical research is far different from
medical care.

Medical care is based on the assumption that a doctor sees a patient as an
individual and tailors one-on-one treatment. In medical research, doctors
and scientists design a study, called a protocol, to which all volunteers
must rigidly adhere, regardless of the characteristics of any single
patient. "It's not the doctor's best judgment of what's best for you," says
George Annas, chairman of the health law department at Boston University
School of Public Health. Rather, a trial serves the ends of science.

Most of the money for clinical trials, both public and private, goes to
research on cancer and AIDS. But human experiments also test potential
treatments for hundreds of other diseases, from psoriasis to glaucoma, from
osteoporosis to clogged arteries. The Web site of the National Institutes of
Health (www.nih.gov/health/trials/index.htm) offers the most complete list
of clinical trials. Support groups for specific diseases may have further
information.

Whatever the trial, you should find out what questions researchers hope to
answer in their study. The issue could be, for example, whether lung
reduction surgery has a better outcome for people with emphysema than, say,
treatment with bronchodilator {*filter*}. You must be prepared to accept either
surgery or {*filter*}, based not on your preference but on the luck of the draw.

You should ask researchers how many others in the trial have been tested,
how many people the trial needs, and what has happened to participants. For
example, Phase II trials, which test whether a treatment that has been
deemed safe actually works, are designed around probabilities: Researchers
decide they need a certain number of patients, say 20, to prove that a
treatment is ineffective. If 19 patients have been treated, and you are
patient No. 20, clearly you should ask whether the treatment worked on your
predecessors. If it was not effective for all 19, researchers still need a
20th patient to complete the trial. Researchers would not be obliged to tell
patients that the trial didn't work for the first 19 people, since they
would only suspect the treatment was ineffective. Still, you should expect
an honest answer if you ask directly how others have fared.

Second opinions. Physicians involved in clinical research must present
detailed information about risks to patients and make themselves available
for questions before patients sign the required informed-consent documents.
Research assistants, nurses, and others can also answer questions. But
patients should also get a second opinion, advises Alexander Capron,
professor of law and medicine at the University of Southern California. "Get
information from someone with no stake in the research," he says, because
doctors doing the research may be too close to the project to be completely
objective.

If you still have concerns after enrolling in a research trial, you can talk
to the lead researcher of the trial, who is likely to know the most about
the project; the chair of the institutional review board, the group that
oversees all human research in an institution; or the hospital's ombudsman.
If you don't get satisfaction, you can contact the Office for Protection
From Research Risks at the nih (www.nih.gov/grants/oprr/oprr.htm).

Your most important right as a tester of unproven {*filter*} and treatments is
that you can drop out of a clinical trial at any time, for any reasonor for
no reason at all.-Susan Brink

~~~~~~~~~~~~~~~~~~~~~`
Nancy B.
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understanding. In all your ways acknowledge him and he will direct your
paths.
Proverbs 3:5,6 <><

Finders' fees are also paid to physicians to enroll their private patients
in trials.

There was an expose on this out here in OR a year ago. We have tons of
pharamaceutical tests out here, and when you throw in one's own physician
attempting (misusing a power position?) to enroll you (without letting you
know how much he is being paid per entrollee), the interest may well not be
in your benefit.

Rita