Magazine article Work & Family Life

Is a Clinical Trial the Right Choice for Your Relative?

Magazine article Work & Family Life

Is a Clinical Trial the Right Choice for Your Relative?

Article excerpt

You or an older relative may have been asked to become part of a clinical trial, the scientific term for a research study with human volunteers to answer specific health questions. Clinical trials are required by the U.S. Food and Drug Administration (FDA) to make sure that new medications and treatments are safe and effective for people to use.

There are different kinds of clinical trials that study: (a) prevention options, (b) new treatments or new ways to use existing treatments, (c) new screening and diagnostic techniques and (d) options for improving the quality of life for people who have serious medical conditions.

Clinical trials follow a plan called a protocol. This describes what types of patients may enter a study, the schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

Understand the rules

Clinical trials are run by doctors and other healtn professionals according to FDA rules to make sure that people who agree to be in the studies are treated as sarely as possible, berore you decide one way or the other about participating, here s some important information from the FDA:

* 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 underrepresented 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 have to sign an Informed Consent. 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 last section 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 knows whether you are receiving the standard treatment, experimental treatment or a placebo (an inactive substance that looks like the drue beine tested). In other words, you might be getting no treatment at all.

Some study drugs also have side effects that can be unpleasant, serious, or even life- threatening. But because they're new, doctors don't always know what the side effects will be. …

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