2006-11-01 / Seniors

Clinical Trials:

What You Should Know

Dear Savvy Senior,

Can you tell me about clinical trials and how to go about finding one? My husband (who's 62) was just diagnosed with early stages of Alzheimer's disease and we are interested in trying anything that may be able to help him. What can you tell me? Clinical Candidate

Dear Candidate:

More and more older patients are volunteering for clinical trials to gain access to the latest, and possibly greatest, but not yet on the market, treatments for all types of serious illnesses. Here's what you should know.

Clinical Trials

A "clinical trial" is the scientific term for a test or research study of a drug, device or medical procedure using people. These tests are done to learn whether a new treatment is safe and if it works. But, keep in mind that these new treatments are also unproven ones, so there may be risks too. Also, note that all clinical trials have certain eligibility criteria (age, gender, health status, etc.) that you must meet in order to be accepted, and before taking part in a trial, you'll be asked to sign an informed consent agreement. You can also leave a study at any time you choose. To learn more or to locate an Alzheimer's disease clinical trial near you, visit the Alzheimer's Disease Education and Referral Center at www.nia.nih.gov/alzheimers and click on "Clinical Trials" or call 800-438-4380.

Things to Know

Before you decide to participate in a clinical trial of any kind, schedule an appointment with the study's medical team and ask lots of questions. Here are a few to help get you started.

 What is the purpose of the study? (You may be surprised to know that many drug or procedural trials are not designed to find a "cure" but to achieve more mod- est goals, such as to slow down the progression of a disease.)

 Is the trial you are considering best for your situation?

 What advantages does the trial's experimental treatment offer over existing treatments?

 What are the risks? (Some treatments can have side effects that are unpleasant, serious and even life threatening.)

 What kinds of tests and treatments does the study involve, and how often and where they are performed?

 Is the experimental treatment in the study being compared with a standard treatment or a placebo? (If you get the placebo, you'll be getting no treatment at all.)

 Who's paying for the study? Will you have any costs, and if so, will your insurance plan or Medicare cover the rest? (Sponsors of trials generally pay most of the costs, but not always. Also, note that federally funded trials are regulated by the government and ensure strict safety guidelines.)

 What if something goes wrong during or after the trial and you need extra medical care? Who pays?

 Can you stay on the treatment after the study is completed? If so, who will pay for the treatment?

Finding a Study

To learn about the many different types of clinical trials near you, try these resources:

 National Institutes of Health: They offer the premier Web resource for locating federally and privately supported clinical studies on a wide range of diseases and conditions. See clinicaltrials.gov.

 National Cancer Institute: Provides cancer-specific clinical trials. Go to cancertrials. nci.nih.gov or call 800-422- 6237.

 National Center for Complementary and Alternative Medicine: To find alternative medicine trials, visit www.nccam.nih.gov or call 888-644- 6226.

 International Federation of Pharmaceutical Manufacturers & Associations: To locate drug company trials, see ifpma.org.

Savvy Tip: A good resource to help you get more information on clinical trials and how they work is CenterWatch, a Boston-based company that tracks the industry. They also offer several helpful publications, including "Volunteering for a Clinical Trial" and "Understanding the Informed Consent Process" ($3 each) which can be ordered online at www.centerwatch. com or by calling 800-765-9647.

Send your senior questions to: Savvy Senior, P.O. Box 5443, Norman, OK 73070, or visit www.savvysenior.org. Jim Miller is a contributor to the NBC Today show and author of The Savvy Senior books.

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