Shimada Y
Gan To Kagaku Ryoho. 1994 Oct;21 Suppl 3:315-24.
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.
开发新型抗癌药物对于提高癌症患者的反应率和生存率至关重要。国家支持的组织在开展极具实验性、成本高昂且符合伦理的临床试验方面发挥着关键作用。在美国，国立癌症研究所（NCI-US）已指定六个癌症中心为“新药评估一期机构”，由NCI提供资金支持。癌症治疗与研究中心（CTRC）和日本筑波大学附属医院癌症中心（JHOC）是开展一期试验的活跃中心。它们每年评估超过10种新药。其团队由年轻医生、研究护士、数据管理人员、药理学家、技术人员以及在强有力领导下的首席研究员组成。最近，美国、欧洲和日本在政治上假定要进行国际协调。然而，我们必须认识到这种相互关系还有另一个含义，即在新药开发领域相互之间的“国际竞争与比较”。
