The basics of clinical trials
What is a clinical trial?
Clinical trials are research studies that involve people. Each study tries to answer scientific questions and ultimately find better ways to prevent, diagnose, or treat cancer.
Before a new treatment is used with patients, it is carefully studied in the laboratory. This initial research reveals methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. While not a precise predictor of how new treatments will work, clinical trials help further identify risks and potential benefits.
What are the different types of clinical trials?
- Treatment trials test new therapies, like a new cancer drug, combinations of treatments, or new methods such as gene therapy;
- Prevention trials test new approaches, such as drugs, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer;
- Screening trials test the best way to find cancer, especially in its early stages;
- Quality-of-life trials explore how to improve comfort and well-being for cancer patients.
What are the phases of clinical trials?
Most clinical research that involves the testing of a new treatment progresses in a series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the treatment and also protects patients.
Phase I: These first studies evaluate how a new treatment should be
given, how often, and what dose is safe. A Phase I trial usually involves only
a small number of patients, sometimes as few as a dozen;
Phase II: A phase II trial continues to test the safety of the treatment
and begins to evaluate how well it works. Phase II studies usually focus on a
particular type of cancer;
Phase III: These studies compare a new treatment to the current standard
for treatment to determine which is more effective. A participant will often
be randomly assigned to the standard treatment group or the new treatment group.
Phase III trials typically enroll large numbers of people, and may be conducted
at doctors' offices, clinics, and cancer centers nationwide.
Find out more information from these sources
If you have been diagnosed with cancer and need more information about your disease or clinical trials, you can call on the following DFCI resources: • Cancer Information Service at (617) 632-3155 • Blum Patient and Family Resource Center at (617) 632-5570 or (800) 525-5068. • Patients seeking physician referrals should call the Dana-Farber/Partners CancerCare patient-referral line at (800) 320-0022. • Resources and links to cancer-related sites are listed under "Cancer Information" on the DFCI Web site: http://www.dana-farber.org.
Another useful site is CancerNet, a service of the National Cancer Institute (NCI). CancerNet, on the Internet at http://cancernet.nci.nih.gov, is a current and accurate source of cancer information. An NCI site with specific information about cancer research studies is http://cancertrials.nci.nih.gov.
