Harvard Women's Health Watch

What clinical trials can do for you

Participating in a medical study may benefit your health and perhaps that of millions of others.

If you’ve ever considered donating your body to science—or granting science a temporary loan—now’s the time to do it. Researchers are always recruiting patients for studies of new treatments and preventive strategies for diseases ranging from Alzheimer’s to zoster (shingles). In the simplest terms, these studies compare existing approaches to newer ones in similar groups of people and determine which is more effective.

“Clinical trials are the vehicle by which we transfer things that we think into things that we know or don’t know,” says Dr. Jeffrey Drazen, professor of medicine at Harvard Medical School and editor in chief of The New England Journal of Medicine.

Dr. Drazen notes that the ways clinical trials are conducted are constantly being revised to yield better information and improve the experience for participants.

Two types of studies

There are two basic types of medical studies—randomized, controlled clinical trials (RCTs) and observational investigations.

In an RCT, one group of participants is randomly assigned to receive the treatment being studied, while another group (or groups) receives either a different treatment or an ineffective one—a fake procedure called a sham or an inactive pill called a placebo. The Women’s Health Initiative, which identified risks associated with postmenopausal hormone therapy, was an RCT.

In an observational study, participants aren’t given any specific treatment, but researchers observe them to see how their habits relate to their health. The Nurses’ Health Studies, involving more than 200,000 women, have provided a wealth of information on how lifestyle practices influence health risks.

What you can gain

Clinical trials offer several benefits, including the following:

Access to state-of-the-art care. If you’re in a study of a new treatment, you’ll receive either the best existing therapy or a promising new approach, even though you won’t know which you are receiving. You’ll be carefully monitored by medical teams.

The chance to receive a promising new treatment. Not all new drugs or devices tested become “breakthrough” therapies, but if the one in your study does, you could be among the first beneficiaries.

Free care. Many trials cover the cost of medical treatment if your insurance doesn’t, and some may even compensate you for participating.

The opportunity to contribute to medical knowledge. Not only will you help researchers determine how effective a treatment or lifestyle practice is, you’ll contribute to information about its effectiveness in women, who have been underrepresented in clinical trials.

What will be required of you

You may want to think of participating in a medical study as a volunteer activity or part-time job. It can require the following:

A time commitment. You may need to travel to a medical center for occasional tests or to fill out extensive questionnaires.

Diligence. You’ll provide better information if you adhere carefully to the instructions—taking medications as directed, answering questionnaires completely, and keeping appointments.

Accepting risk. There is always a risk of an adverse effect with a new—or even established—treatment. Be sure to read the consent form and make sure you understand it before you join a study.

How to find a clinical trial

If you are interested in joining a clinical trial, ask your clinician about studies in your area. Also, www.clinicaltrials.gov , a website operated by the National Institutes of Health, lists ongoing studies.

You can participate in this study without leaving home

Researchers from Harvard-affiliated Brigham and Women’s Hospital and the Fred Hutchinson Cancer Research Center are conducting the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) to test whether taking a cocoa extract supplement and a multivitamin daily can reduce the risk of heart attack, stroke, and cancer.

If you’re 65 or older (60 or older for men), have not previously had a heart attack or stroke, and have not been diagnosed with cancer (other than skin cancer) within the past two years, you may be eligible to participate in COSMOS.

If you join, you'll take three pills each day—two capsules containing cocoa extract or placebo, and one tablet containing a multivitamin or placebo. (You’ll be randomly assigned to a treatment group and won’t know what your pills contain until the end of the study.) You’ll complete questionnaires in which you are asked about your health habits, recent health, and whether you've been taking your study pills. You’ll also get newsletters and updates from the researchers as the study progresses. Although you’ll need to stop taking multivitamins and cocoa supplements, you won’t have to abstain from chocolate!

To join, call 800-633-6913 or email cosmostrial@partners.org.

Learn more about our
health content.