to your health
Joining a clinical trial?
by cynthia lee
ucla today staff
If it weren’t for clinical trials that test experimental
drugs on human subjects, medical science wouldn’t be where
it is today. And many Americans realize this. When asked whether
they would be willing to participate in a clinical trial, 63% of
those surveyed recently by a popular news magazine said they would.
An informed consent form that you must sign will spell out your
right to know all the possible risks, side effects and discomfort
as well as the potential benefits of a trial. Yet studies show that
most volunteers indicate they don’t even know what questions
to ask. As a research subject advocate at UCLA, Laurie Shaker-Irwin
advises people on how clinical trials work and what volunteers should
know.
During the 12 years it typically takes for an experimental drug
to go from laboratory testing to your medicine cabinet, there are
three phases of clinical trials. The first phase, testing 20-80
healthy volunteers for about a year, determines the safety and dosage
level of the drug. The second, lasting roughly two years with 100-300
patient volunteers, evaluates the drug’s effectiveness and
side effects. The third, involving 1,000-3,000 patient volunteers
for about three years, verifies the drug’s effectiveness and
looks for adverse reactions from longterm use. There’s even
a fourth phase of FDA-required testing after the drug is marketed.
Along the way, the FDA and an Institutional Review Board (IRB),
a local panel made up of medical experts, clergy, community members
and others who insure that the trial is ethical and that participants’
rights are protected, initially approve and periodically review
the data. There may also be mandated reviews by other regulatory
bodies. “We have to balance progress with safety,” she
said.
Here are some other considerations:
• Make sure you know the risks involved — physical,
emotional and financial. Patients are often reimbursed for their
time, gas and other incidental expenses. But, know also that anything
done during a clinical trial that would typically have been done
in the normal course of your treatment will be billed to your insurer.
• Ask what will happen when the study ends. Will you be told
whether you were taking the drug or the placebo? And if the drug
is effective, will it be made available to you after the trial,
or must you wait until it comes on the market?
• Ask if there are any conflicts of interest. Know who is
paying for and conducting the trial.
• Have an understanding of the Health Insurance Portability
and Accountability Act, which protects the confidentiality of your
medical records. Know who will have access to those records.
To search for a clinical trial, visit www.centerwatch.com. UCLA
lists selected clinical trials at www.centerwatch.com/professional/pro770.html. |
