Why are clinical trials important?Without clinical trials, there would be no new treatments for cancer. Under most circumstances, doctors in the United States cannot treat patients with experimental drugs or treatments unless they have been carefully tested and licensed for patient use by the federal Food and Drug Administration. FDA experts analyze the results from clinical trials to determine whether new therapies are safe and more effective than established treatments. Without FDA approval, new cancer drugs or therapies cannot be marketed in the United States.
What are the phases of a clinical trial?Clinical trials of new cancer drugs or treatments are conducted in a series of stages called phases:
Phase I: researchers find out whether the experimental drug or treatment is safe for people and what side effects it causes.
Phase II: researchers use phase II trials to find out if the experimental drug or treatment is effective against a specific type of cancer.
Phase III: these studies (trials) are designed to compare, in matched groups of hundreds or even thousands of patients, the results from experimental treatment with results from conventional treatment. Unless the experimental treatment is shown to be safe and more effective than conventional treatment, it is unlikely to be approved by the FDA for general use in patients.