Abstract
In order to gather clinical case data efficiently, it has been suggested that creating opportunities for communication among coworkers, comprising the medical doctors, patients with the disease, clinical researchers and clinical research coordinators, is important based on a detailed examination of the four different types of drug development processes investigated in a previous report. Unfortunately, the collaborative approach to progressing a new drug development program does not work well in Japan because the existing clinical trial system does not provide communication opportunities for the coworkers participating in the drug development program to meet together in one place. The objective of this paper is to explain the planning process needed to set up a clinical communication platform for a new drug development program, covering the stages from the basic research into drug development up until commercial release. With reference to the MMRF (Multiple Myeloma Research Foundation) / MMRC (Multiple Myeloma Research Consortium) in the U.S, which have excelled in new drug development, the necessary functions of the clinical communication platform will be discussed. Several issues will then be considered in relation to how a new drug development program should be managed, considering the status of industry-government-academia collaboration for regenerative medicine development in Japan.
