Participating in clinical trials confers many benefits. Enrollees often have access to new drugs that may improve their conditions. They also receive focused attention and monitoring from medical experts and usually learn more about their diseases. Many hear about support groups and other resources and may get a psychological boost from taking some control of their diseases and knowing they're contributing to research.
The number of trials has increased as more drugs are being developed and tested, which makes finding a trial easier than in years past. All clinical trials in the United States (both privately and publicly funded) are listed at ClinicalTrials.gov, and some are also advertised in newspapers or on television. Most patient organizations and many physicians are aware of upcoming trials and can provide information.
Many clinical trials take place in academic institutions to which participants have to travel. In some instances, patients can undergo preliminary testing at their doctors' offices or local hospitals and even interact with researchers via telephone or video. In addition, enrollees may be reimbursed for travel expenses, so be sure to ask. The length of time needed for participation can vary from months to years, since trials often reach out to participants for follow-up, sometimes even decades after the original trial began. Depending on the trial, you may have to appear in person (if you work, you might have to request time off) or participate by video conference call or telephone.
Before joining a trial, subjects fill out paperwork, including consent forms, to be sure they understand what is expected of them and know any potential risks from treatment if they receive it. Trial coordinators go over all details and answer any questions. Ask as many questions as needed to feel comfortable enrolling. Potential participants often talk to family members first or bring them to preliminary meetings and trial sessions.
Bear in mind that clinical trials are experimental. Whether you receive a drug or treatment or a placebo, you won't be told which one, and your symptoms could improve or worsen regardless of what you receive. Throughout the trial, you will be watched over by a health team and asked to report any new symptoms, which may or may not be related to your medical condition, the treatment, or the placebo. All participants—even those who receive placebos—are contributing to medical research. In most trials, enrollees may get access to treatments or doses not yet available to the general public. People who received placebos may get faster access to the drug because they participated in the trial. Or if a drug appears to be working, those getting placebos may be switched to the drug and followed to collect more data.
Many clinical trials now pay patients to participate, so be sure to inquire about compensation, covered costs, and whether the researchers will pay expenses or reimburse patients, as well as family members and caregivers.
Being accepted into a trial is not a given. Most people are accepted if they match all the inclusion criteria, which vary from trial to trial. Applying early could increase your chances of being accepted if you are otherwise eligible. Potential candidates may be excluded because of age, state of their disease, or coexisting conditions, or because the trial has enough recruits. Don't give up. Instead, go back to your doctor, patient organization, or ClinicalTrials.gov to see if other studies are available for which you might be eligible.
In rare situations, usually involving life-threatening disorders, the U.S. Food and Drug Administration might grant a “single patient exemption” for someone who doesn't meet all criteria but has no other options.
Dr. Hallett, former chief of the medical neurology branch of the National Institute of Neurological Disorders and Stroke, is now a distinguished investigator emeritus at the institute.
