Clinical trials can give you access to the latest medicines and treatments. But before you volunteer for one of these research studies, you need to thoroughly understand what you're getting into.
What exactly is a clinical trial?
Clinical trials are medical research studies that rely on human volunteers. These studies determine if a new treatment—such as an experimental drug to control high blood pressure—is safe and effective. They may also be used to test new uses for existing treatments.
Clinical trials have ushered in some of medicine's most important breakthroughs, from the protease inhibitors that extend the lives of people with AIDS to the latest cancer treatments.
Still, it is crucial to remember that these trials are, first and foremost, medical research studies, cautions the U.S. Food and Drug Administration. No one, including the doctors who oversee clinical trials and the volunteers who participate, knows whether the treatments being tested will actually work.
Why should I consider volunteering?
By volunteering, you may gain access to a promising new treatment that is not yet widely available. This may be particularly advantageous if you are ill and no conventional treatment can control the disease. Also, you can help others by contributing to medical research.
What are the risks?
Again, there are no guarantees that the treatment under investigation will work. Additionally, in some trials neither you nor your doctor will know if you are receiving the experimental treatment, the standard treatment or a placebo ("dummy pill" with no active ingredients). Thus, you can't assume that by participating in a trial you will obtain the newest treatment.
Moreover, because the treatments being tested are often new, doctors can't always anticipate possible side effects—either temporary or permanent.
How can I protect myself?
Before signing on, make sure you know the answers to key questions, such as:
- What is the purpose of this study?
- What are the qualifications of the researchers?
- How might I expect to benefit from this study, and what are the expected risks?
- If I am injured, who will take care of me or pay for my treatment?
- How will my privacy be protected?
The study's details will be explained in an informed consent form. This form is not a contract. Volunteers can leave a clinical trial at any time, for any reason.
What other safeguards exist to protect participants?
Under federal guidelines, every trial in the United States must be approved and monitored by an institutional review board (IRB). This independent committee of doctors, statisticians and community advocates initially approves and then reviews all research to make sure any risks to volunteers are as low as possible and worth the potential benefits.
How are volunteers selected?
All trials have participation guidelines based on factors such as age, medical history and current health status. Some trials seek volunteers with illnesses or conditions to be studied in the trial, while others seek healthy volunteers.
Where can I find out about ongoing clinical trials?
Once hard to track down, information on clinical trials is now available at clinicaltrials.gov. Managed by the National Institutes of Health, this website gives the location, purpose and participation criteria of thousands of clinical trials all over the world. For specific information on cancer-related trials, visit the National Cancer Institute website at cancer.gov.
If you have questions about whether joining a clinical trial is a good idea, talk to your doctor.
Reviewed 11/29/2023