薬理と治療

Abstract

Objectives In a clinical trial‒planning phase, to set the appropriate goal and to evaluate risks properly have major impacts on the success or failure of the clinical trial. Although check lists had been known such as SPIRIT statement and TransCelerate RACT（Risk Assessment Categorization Tool）, these put emphases on the contents determined by the trial protocol such as data management, data analysis. Thus, we attempted to make a new risk assessment tool followed by quality by design to evaluate on the basis of research inherent risks and operational management process risks and also the risks originated from the trial design. Methods We had created a new risk assessment tool with quality management plan template working group（WG）members consisted of researchers（medical doctors）, ARO or CRO staffs, highly skilled R&D specialists in trial management and quality control operations in the pharmaceutical company. It should be noted that this WG supported as a commissioned project from the Center for Clinical Trial, Japan Medical Association. Results We developed the risk assessment tool that will be able to assess the trial risks in terms of inherent risks and implementation system risks. We considered the risk assessment viewpoints in terms of study design, safety, research management and medical institutions. Conclusions We supposed that this risk assessment tool will play the important role to conduct the clinical trial based on the quality management plan.