[Present strategy for new drug development in the USA].

Development of new anticancer drugs is essential to improve the response and survival of cancer patients. Nationally supported organizations have a key role in conducting very experimental expensive and ethical clinical trials. In the U.S., the NCI-US has designated six cancer centers as "phase I institutes for new drug evaluation," supported by NCI funding. CTRC and JHOC are active centers for phase I trials. They have evaluated more than 10 new drugs a year. Their team consists of younger physicians, research nurses, data managers, pharmacologists, technicians and the primary investigator under strong leadership. Recently, international harmonization of the U. S., -Europe and Japan is postulated politically, However, we have to recognize that this interrelationship has another meaning, that of "international competition and comparison" with each other in the field of new drug development.