The appropriate use of and compensation for investigational cancer the
rapies raises a number of ethical, policy-related, and financial consi
derations. Ethical considerations include the use of therapeutic regim
ens for individuals versus controlled clinical trials, the extent of i
nformation necessary to indicate that a therapy may be safe and effect
ive, and the informed consent of the patient. Financial concerns inclu
de the status of the therapy in the evaluation phase within the Food a
nd Drug Administration, the policy of third-party payers, and the curr
ent state of medical knowledge. The policy-related considerations are
those regarding the use of and payment for investigational therapies.