Centuries ago, bloodletting was the first-line treatment for many illnesses. Today we enjoy an abundance of advanced medications and therapies that successfully treat or cure a variety of diseases.
How did we get from there to here?
It all starts with rigorous clinical trials.
A clinical trial is a research study that tests the effectiveness of a new drug or treatment, either individually or in comparison to available therapies. Every trial follows a protocol, a detailed plan mapping out every phase, from selecting participants to processing data.
Many trials, of course, require volunteers who have the medical condition being studied. Others seek people whose family medical history may make them predisposed to a certain condition, and some need participants of a certain gender, age or ethnicity. Guidelines for clinical trials in the United States demand that an independent committee of physicians, statisticians and community members approve and monitor the protocol, after determining that the potential risks to subjects are minimal and worth the potential benefits.
Clinical Trials Are Not Just for Sick People
"There are all kinds of clinical trials, not necessarily just to test new drugs," says Kay Dickersin, director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health. Trials, she says, could investigate questions from whether eating cereal every morning might improve one's health to whether zinc lozenges are effective for treating a cold. "If, when you get sick, you want the answer as to whether something works or not, you can be part of the science that figures that out," Dickersin says.
Clinical trials often make headlines when they represent potential breakthroughs in the search for cures, or last-ditch options for chronically ill patients. But while many people assume that all participants in clinical trials must have the condition being studied, in fact ongoing studies rely on healthy volunteers to serve as control subjects. These people may not actually take the medication that's being tested, or they may take a placebo, a pill or liquid that looks like the new treatment but does not have its active ingredients. Those who do end up taking an experimental drug or drug combination can provide valuable data about both its effectiveness and its side effects. When you read about the side effects of any medication, you can credit that information to the participation of both healthy volunteers and participants who had the condition being treated.
How to Find a Clinical Trial that's Right for You
The National Institutes of Health recently launched a website, Clinical Trials and You, that provides answers to many questions about participation, from a study's potential duration and demands to the general risks and benefits of getting involved. The site also offers key questions you should ask yourself and researchers before volunteering to help move a therapy or drug from theory to reality, or "bench to bedside," as researchers say.
You can also ask your doctor if he or she is aware of any trials for which you're a good candidate. "I knew about clinical trials," says journalist Eileen Beal, 67, of Cleveland, "but I never thought to ask my doctor, 'Are you involved in a trial? Would I be of benefit to you?'"
But then, about eight years ago, her doctor introduced her to the nationwide Study of Tamoxifen and Raloxifene, which looked at the effectiveness of two drugs in warding off breast cancer in post-menopausal women. Beal, who has not had breast cancer, became one of nearly 20,000 women who took part in STAR, one of the largest breast cancer prevention studies ever.
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If you're interested in advancing treatments for a specific disease, you can contact the various organizations that focus on it. For example, the Alzheimer's Association regularly recruits volunteers for its trials.
But while you can be confident that a study promoted by a group like the Alzheimer's Association is legitimate, a more critical eye is required to judge radio, print or TV ads offering cash or products in exchange for taking part in research studies. Here's what you need to know:
- Every legitimate clinical trial will ask you to sign an "informed consent" document. Look this over carefully, ask any questions you have, and share the information with your doctor if you have any doubts.
- Ask which ethics review board, or institutional review board, has approved the study. "That information, and a phone number to the review board, should be on the consent form," Dickersin says. "If you have any questions about the legitimacy of the trial, call the review board."
- Finally, all bona fide clinical trials conducted in the United States must be registered with the NIH, so consult the agency's listings, at ClinicalTrials.gov, before signing up for any study. If a trial isn't registered with the NIH, that should be seen as a major red flag.