 |
|
|
Cancer Clinical Trials: Are They Right for You?
What Is a Cancer Clinical Trial?
Before a new treatment method is made available to the public, it must undergo a clinical trial. These strictly monitored and carefully evaluated trials test the therapy's safety and efficacy and are conducted in communities nationwide by the cooperative groups (see page C2), the pharmaceutical industry, cancer centers, and other academic and hospital centers. Three phases of clinical trials must be successfully completed before the Food and Drug Administration (FDA) grants approval for marketing.
Phase I trials of promising new treatments are initiated after extensive laboratory research, trials on animals, and the filing of an Investigational New Drug (IND) application with the FDA. Such trials establish the right dosage and measure side effects (toxicities). As few as a dozen, and rarely more than 50 or 60 people, who might have no other treatment options, participate in this stage.
Once the correct dosage is established and the side effects are known, Phase II trials, usually involving fewer than 100 participants, evaluate whether the new treatment actually has a positive effect against the cancer. In general, if at least 20 percent of the patients respond to the treatment, the new therapy undergoes further evaluation.
Although the first two phases of study involve relatively few patients, the final trial stage before FDA approval, Phase III, requires a large group of participants, numbering in the hundreds to the thousands. In these trials, the new drug, combination of drugs, or procedure is compared to the best existing treatment. Most often, Phase III trials are randomized; that is, one group is assigned by chance to receive the study agent while one group does not.
 Back
Next Page
|
|
