薬理と治療

Abstract

Objectives This article aims to reveal actions and progress on the Clinical Trials Act in Japan. Especially we focused on research and configuration of contracts of clinical research for good operational procedures for medical institutions. Methods We reviewed criteria and notification about the clinical research. We identified factors that may effect on each type of contract. In addition, we extracted configuration of contracts and reality of situations between in Japan and in other countries to examine the rules of legislation regarding the clinical research under the rule of pharmaceutical industry in Japan. Results We focused on 4 points below, based on the patterns before the Clinical Trials Act coming into operation;1, classified configuration of contracts, 2, identified factors that may effect on each research contract and compare how legislation changes from conventionally style, 3, detail of the envisioned legislation and rules, 4, analysis of characteristics and characteristics extraction. We roughly grouped clinical research into two types, investigator‒initiated and company‒initiated. Role allotment between researchers and companies is summarized in Table1. Positive and negative lists along company’s function are shown in Table2. Conclusions We categorized the clinical research according to responsibilities, initiation and implementation. We assumed that the coauthor of the study, the clinical research organization may be considered desirable under the Clinical Trials Act.