Japan's MHLW to facilitate clinical trials

A new panel at Japan's Ministry of Health, Labor and Welfare to compile a mid-term plan for facilitating clinical trials in Japan has launched its first round of discussions on the education and training of clinical trial investigators, clinical research coordinators, institutional review board members, data managers and bio-statisticians as its first round of discussions on July 25 (Marketletter July 10).

Noting that there are relatively few Japanese physicians wishing to participate in clinical trials, Haruko Yamamoto, a cardiologist at the National Cardiovascular Center and a member of the MHLW's new panel, proposed the establishment of a system which includes two new incentives: 1) participating in clinical trials would allow physicians to gain a point in getting physician certification; and 2) results/achievements of participating in clinical trials would raise the priority condition of physicians who apply for research subsidies. However, the latter provision would need to avoid giving a direct financial benefit because of the potential moral hazards involved.

Yukiko Enomoto, clinical research coordinator at Nihon University Itabashi Hospital, stressed the need to standardize the term and contents of training and education, and to stabilize employment of CRCs to increase their numbers and to improve their quality.