EL2 CHANGES IN JAPANESE ACADEMIC CLINICAL TRIALS AND FRAMEWORKS FOR PLANNING CLINICAL TRIALS

After the enforcement of the Japanese Clinical Trials Act, the number of investigator-initiated registration-directed trials (IIRDT, Chiken) is increasing while the number of non-registration academic trials is decreasing. Pharmaceutical companies tend to make an investment in IIRDT because the data derived from IIRDT can be utilized for new drug application for PMDA, which means the goals and return are clear for industries. On the other hand, the reason of the decrease of non-registration academic trials is the burden of cost and procedures specified in the Clinical Trials Act. In order to start academic trials, certain amount of research budget is indispensable due to the cost for certified review board and clinical trial insurance. Also, even minor changes of site information in jRCT should be submitted to certified review board and the hospital directors of all participating sites, which is one of the most serious burden for investigators. Confirmation of COI declaration in participating sites is another burden for investigators/sites. Under these circumstances, the number of non-registration academic trials will be decreasing for the time being. In the Clinical Trials Act era, investigators must prepare some budget to start clinical trials. In order to obtain public funding, social/scientific value and scientific validity are substantially important. To express the social value sufficiently, the purpose of the trial should focus not on the researcher’s interest but on the contribution for patients. In terms of scientific validity, the framework of PICO is useful; PICO means Patient, Intervention, Control and Outcome. Utilization of this framework and the consistency of these four factors are essential to make the trial design sound.