Abstract
In developing a drug, it is essential to conduct a clinical trial to confirm that it is safe before commercial release for use in hospitals and clinics. In Japan, considerable time and effort is required to recruit study subjects and gather clinical case data for a clinical trial for a newly developed drug. The more quickly and efficiently a clinical trial can be conducted, the sooner the drug in question can reach the waiting patients and their families, and the lower the drug development cost incurred by the pharmaceutical company concerned. We have closely examined the process of gathering clinical case data for clinical trials for four different types of drugs. We found that the conventional approach of regarding the disease conditions of study subjects as clinical “case samples” does not work well. Rather, we should regard the series of processes from the start of a clinical trial to reporting of the analysis results to the Ministry of Health and Welfare as a “clinical trial program“ and consider study subjects as coworkers in this program. It is important to make sure that the study subjects understand the objectives, background and rules governing the program.
