Investigational trials of anticancer drugs: establishing safeguards for experimentation.

The National Cancer Institute since 1955 has been charged with responsibility for discovering new anti-cancer agents and bringing them to clinical trial. These activities are carried out by NCI's Developmental Therapeutics Program, which has established systems for discovery, experimental testing, bulk synthesis, formulation, and toxicological testing of candidate drugs, and by the Cancer Therapy Evaluation Program, which conducts initial trials to establish safe doses of new agents and to determine their utility in treating specific forms of cancer. These clinical trials are conducted both at NCI in Bethesda, Md., and at selected cancer centers throughout the United States. This paper describes the safeguards that NCI has built into the clinical trials system in the past decade-safeguards that ensure the safety of patients and the accuracy of data collected and at the same time allow efficient testing of each promising new agent in the fight against cancer. Recent improvements in cancer survival leave little doubt that patients are indeed benefiting from extensive efforts to discover and develop new drugs for cancer treatment.