Clinical trials, conducted at cancer centers, hospitals and medical clinics, are the final step in the development of new drugs and therapies. Their ultimate goal is to obtain FDA approval to put a drug on the market or to use an already marketed drug in a new way.
If you have cancer and want to join a trial, finding the right one may not be easy. While still under the care of her local oncologist in Northern California, melanoma sufferer Kari Worth spent a challenging year hunting for a clinical trial that would offer the latest experimental medicine. She had a hard time finding one that would accept her because patients must meet a range of very specific requirements—involving, for example, how advanced their cancer is, what drugs or surgery they have had before—to qualify. Worth finally landed one 450 miles south of her home, near Los Angeles.
Clinical trials come in five phases (0 to 4), but the most available and useful are phases 1 to 3. Phase 1 trials, studying 15 to 30 patients, evaluate a drug’s safety and how it should be given (i.e., as pills or by injection or infusion). Phase 2 trials, with fewerthan 100 patients, test the drug’s effectiveness. Phase 3 trials, with 100 to several thousand patients, compare the drug with the current standard of therapy.
These trials are randomized, which means that half the patients get the new drug and the other half get the current standard. While new cancer drugs tend to be tested first in patients with late-stage disease, there are exceptions: The Foundation for the National Institutes of Health, a public-private partnership, is supporting a phase 2 trial called I-SPY that’s aimed at giving new drugs to certain patients with early-stage breast cancer.
There are pros and cons to joining a clinical trial. The pluses: You have access to a cutting-edge treatment that’s not generally available; you receive a lot of attention from the country’s leading doctors and their teams; you usually get treated for free; and you’re helping future
patients. The downside is that you may be in the control group, and even if you’re not, the new drug may not help you. You may also need to travel a great distance for treatment or even relocate far from family and friends.
The National Cancer Institute’s website (cancer.gov) provides specific information about clinical trials. Advocacy groups for different types of cancer also have sites (for example, breastcancer.org and the Melanoma Research Foundation’s melanoma.org) that can help you find trials that match your situation.
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