Ethical and financial considerations in third-party support of investigational cancer therapies.

Abstract

The appropriate use of and compensation for investigational cancer therapies raises a number of ethical, policy-related, and financial considerations. Ethical considerations include the use of therapeutic regimens for individuals versus controlled clinical trials, the extent of information necessary to indicate that a therapy may be safe and effective, and the informed consent of the patient. Financial concerns include the status of the therapy in the evaluation phase within the Food and Drug Administration, the policy of third-party payers, and the current state of medical knowledge. The policy-related considerations are those regarding the use of and payment for investigational therapies.