September 2003

 

Is a clinical trial right 
for your older relative?
Beverly Pfeiffer, PfeifferB@missouri.edu

You or your older relative may have been asked to become part of a “clinical trial”, the scientific term for the study of a new drug or medical device. Clinical trials are required by the U.S. Food and Drug Administration (FDA) to make sure that medical treatments are safe and effective for people to use.

Clinical trials are run by doctors and other health professionals according to strict FDA rules to make sure that people who agree to be in the studies are treated as safely as possible. But before you decide one way or the other about participating, here’s some information about clinical trials from the FDA as reported in Caregiving newsletter:

Minorities and women are urged to participate. In the past, most drug testing was done on white men. Thus, important groups of the U.S. population (women, African Americans, Latinos, Asian Americans and Native Americans) have been under-represented in the testing. Because drugs work differently on different people, the FDA wants individuals from as many groups as possible to be included in clinical trials.

The Informed Consent agreement is for your protection. Before you take part in a clinical trial, you will be required to sign an “Informed Consent” agreement. The information in this agreement should be clearly written so you can understand it. If you don’t understand it, ask the doctor or other medical person to explain it. See the box on page 4 for a list of questions to ask. Be aware that the Informed Consent agreement is not a contract. You can leave the study at any time, for any reason.

Give thought to the risks. Many studies require that neither the clinical trials participant nor the doctor know whether a patient is receiving the experimental treatment, the standard treatment or a placebo (an inactive substance that looks like the drug being tested). In other words, some participants may be getting no treatment at all. Some study drugs also have side effects that can be unpleasant, serious, or even life-threatening. But because the drugs are new, doctors don’t always know what the side effects will be. Some side effects go away when the treatment is stopped while others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and should be fully explained to you in the Informed Consent material.

For more information

A good way to find out if there are any treatments in clinical trials that may be helpful to you is to ask your doctors.

Other sources of information include:

For cancer: Call 1-800-422-6237 or visit http://cancertrials.nci.nih.gov/.

For AIDS or HIV: Call 1-800-874-2572 or visit www.actis.org.

For general information about clinical trials: Call the FDA’s Office of information about clinical trials: Call the FDA’s Office of Special Health Issues at 1-301-827-4460 or visit www.fda.gov/oashi/home.html.

For other clinical trials, visit www.niyh.gov/health/trials/index.

To search for a specific clinical trial, visit www.clinicaltrials.gov.

Before you say yes, ask…

What is the study trying to find out? What kinds of tests will I have to take while I’m in the study? What is involved in each test? How much time does it take? How often will I have to go to the doctor or clinic? Will I be hospitalized? If so, how often and for how long? What are the costs to me? Will my health insurance pay for it? How long will the study last? What follow-up will there be? What will happen at the end of the study? What are my other treatment choices? How do they compare with the treatment being studied? What side effects or negative consequences can I expect? What are the risks to me if I were to get a placebo? How do they compare with side effects of a standard treatment?

Source: Work & Family Life Newsletter, May 2003