Rinsho Shinkeigaku (Clinical Neurology)


A system to enforce multicenter clinical trials with public funds: Introduction of a neurological cooperative group in the United States

Haruko Yamamoto, M.D.1) and Kazuo Minematsu, M.D.2)

1)Department of Advanced Medical Technology Development, Research and Development Initiative Center, National Cerebral and Cardiovascular Center
2)National Cerebral and Cardiovascular Center Hospital

Success of a multicenter clinical trial relies on the good and stable support system including a number of experienced people and sufficient funds. In Japan, lack of the experienced and well-funded support system makes conducting of the multicenter clinical trials very difficult. In the US, substantial amount of governmental funds have been injected to develop the clinical trial infrastructure. The cooperative group system is a model of the US governmental-funded clinical trial support system, in which the researchers can plan and conduct the clinical trials effectively and reliably, cooperating with other clinical research professionals including biostatisticians. Although there are some active oncology cooperative groups in Japan, this system remains unfamiliar to the researchers in neurology. It should be more noticed and utilized widely.
Full Text of this Article in Japanese PDF (355K)

(CLINICA NEUROL, 51: 612|616, 2011)
key words: Clinical research, Multicenter trial, Data management

(Received: 7-Apr-11)