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16 July 1999

Vol. III, No. 2

Health Matters

It's a brave, new world: clinical research

The hot topic these days seems to be clinical research. What exactly is clinical research, and why is it important to me and my family?

The National Institutes of Health (NIH) defines clinical research as any patient-oriented research conducted on human subjects that requires an investigator to directly interact with human subjects. These studies investigate the mechanisms of human disease, therapeutic interventions, and the development of new technologies.

As Deborah Cotton, M.D., assistant provost and director of the Office of Clinical Research at the Boston University Medical Campus, puts it, "Clinical research is important because it is the fastest and safest way to determine which new therapies or treatments work."

In its 1997 report, the NIH Director's Panel on Clinical Research writes that "advances in molecular medicine are providing enormous scientific opportunities. Never before has the bench/bedside interface been more exciting and productive. Never before have clinical trials been more promising as new products of the genetic revolution flow from pharmaceutical and biotechnology companies."

Without clinical research, Cotton says, we would find out about side effects, some potentially lethal, long after a new drug or therapy is used with people. Without clinical research, drugs and treatments that are not effective -- or that even make a condition worse -- could find their way into common practice. Clinical trials allow for drugs and treatments to be tested in closely controlled environments, increasing their safety and efficacy.

While the term clinical research often conjures up negative images of mad scientists who use humans as guinea pigs in their research laboratories, nothing could be further from the truth, says Cotton. "The use of humans as guinea pigs is a popular misconception about clinical research," she says. "Only after something is tested extensively for safety is it then tested in humans. Of course, there always has to be a first human to receive a new drug or treatment, so there's always that aspect to clinical research, but humans being treated as guinea pigs is not an accurate description."

Over the past 50 years there has been an "evolution of protection" for humans participating in clinical trials, says Cotton. Investigators are bound by strict federal regulations and laws regarding the use of humans in medical research. Only an individual capable of giving informed consent (that is, one who understands the study, the potential side effects, and other ramifications of the research) can participate.

Individuals are free to stop participating in a study for any reason and are guaranteed the right to continued health-care services if they leave the trials. In addition, academic medical centers in the United States require the approval of an Institutional Review Board or similar entity prior to the start of a clinical trial involving human subjects.

"There are a lot of checks and balances," says Cotton, "to protect people involved in clinical trials."

While many people are willing to raise money for cancer, AIDS, and other diseases through walks, charity events, or donations, Cotton says, the most direct way to ensure the health of communities and individuals is to participate in clinical trials. People do so for a number of reasons, including the good of involvement in research that may eradicate deadly diseases. People with life-threatening conditions may become interested in clinical research if conventional therapy for their specific illness does not work.

There are a number of ways to become involved in clinical trials. Individuals with known conditions should ask their physician about clinical research programs for which they might be appropriate candidates. Academic medical centers are often involved in clinical trials and seek qualified participants; some advertise in the newspaper and offer compensation for participation. People can call advocacy groups, such as the American Heart Association and the American Cancer Society, to find out about clinical trials in their area. And the National Institutes of Health has a Web site (www.nih.gov) that lists clinical trials across the country, as well as a toll-free number to call, 1-800-411-1222.

"Health Matters" is written in cooperation with staff members of Boston Medical Center. For more information on clinical research or other health matters, call 638-6767.