On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies

PHYSICIANS and members of the public understand that each new drug must, at some point, be given to humans for the first time without confident knowledge of its effects and toxic potential. Although the ethics and constraints necessary for this testing have been discussed widely, there has been little attention given specifically to the first trials of new cancer chemotherapeutic agents (phase I trials). However, new cancer chemotherapeutic agents cannot be treated simply as new drugs; their toxic effects are often so much greater than those of other drugs that the clinical investigator must weigh many conflicting arguments to justify the trial. Referring physicians, in their role as advisors, are often called on to explain the trials and to counsel patients who may enter them. Thus, they should have full appreciation of the nature and ethics of such trials. A phase I clinical trial in patients with cancer does not