considered standard therapy was first given in a clinical Phase I trial. These treatments were given to patients who were willing to be in the forefront of advances in medical knowledge.
The willingness of thousands of women to participate in clinical trials by the National Surgical Adjuvant Breast Project (NSABP), for example, has resulted in answers being given to extremely important treatment questions. These trials have formed the basis for adjuvant chemotherapy in breast cancer patients with a high risk for recurrence even though no apparent tumor is left after surgery. This has saved many lives. All because of the usefulness of these clinical trials.
The Three Phases of Clinical Trials Whether for surgery, chemotherapy, radiotherapy or biological therapy, clinical trials are always conducted in three phases.
A chemotherapy clinical trial, for example, proceeds this way:
• Preliminary After a new anticancer drug has been found to be effective against one or more experimental
tumor systems in the lab, it is tested in rats or other small animals to find out which dosage might be both
effective and reasonably safe.
• Phase I About 20 human patients are treated with the same drug. There is no assurance or certainty that a
significant tumor response will occur, although, again, every single anticancer drug now useful in therapy was
