In the United States, research involving humans must follow strict scientific and ethical guidelines. Every clinical trial has a plan (protocol) that describes exactly what will be done in the study and how it will be conducted.
All clinical trials that receive funding from the federal government or that evaluate a new drug or medical device that is subject to FDA regulation require review and approval by an expert scientific panel and an institutional review board (IRB) that includes doctors, researchers, and patient advocates. With these safeguards in mind, is a clinical trial right for you?
Every clinical trial has strict eligibility requirements. In phase II and III trials, participants must be as similar as possible in terms of medical history, age range, overall health, type and stage of disease, and previous treatments. Meeting these strict requirements helps ensure that the clinical trial results truly reflect a difference between two treatments, not some other fundamental difference between the patients.
If you meet the enrollment criteria, you will talk to the study coordinator, who will explain the purpose and scope of the clinical trial. Make sure you understand all of the risks and benefits. The risks may include being given a new treatment that is not found to be better than the standard treatment; experiencing unexpected, sometimes serious side effects; and undergoing more tests than you would typically need. The benefits may include access to a treatment not otherwise available, access to high-quality care and monitoring, and learning after the trial is over that the treatment you received was more effective than the standard treatment.
Don't enroll in a clinical trial until you know what costs, if any, you will be responsible for. Laws vary from state to state and not every insurance company will cover the costs associated with every clinical trial. Medicare covers some, but not all, routine care costs for clinical trials (such as doctor visits, hospital stays, lab tests, and x-rays). However, it does not cover costs incurred during cancer prevention trials, and it does not automatically provide for coverage to participants who enroll in clinical trials not funded by federal agencies.
If you decide to enroll in the clinical trial, you'll be asked to sign an informed consent form indicating that you've been given detailed information about the clinical trial and that you haven't been forced to participate. However, an informed consent form is not a contract. You may ask questions at any time or drop out at any time for any reason.
Clinical Trial Resources:
- Coalition of Cancer Cooperative Groups
Established in 1997, the goal of this nonprofit group is to improve patient awareness of clinical trials. Go to www.cancertrialshelp.org or call 877-227-8451
- National Cancer Institute (NCI) Clinical Trials Search
A searchable database maintained by the National Institutes of Health. Go to www.cancer.gov/clinicaltrials/search or call 800-4- CANCER (800-422-6237) The NCI also offers a useful publication, "How to Find a Cancer Treatment Trial: A 10-Step Guide," which is available at www.cancer.gov/clinicaltrials/finding/treatment-trialguide/ page1
