研究者主導臨床試験に望まれる安全性情報の取扱いについて

Timely reporting and appropriate response to safety information related to ongoing clinical trials is crucial for conducting trials appropriately and safely. However, it is difficult to understand exactly what, when, and to whom information should be reported because there are different types of clinical trials in Japan, governed by different laws and regulations. For example, principal investigators need to report serious, unrelated adverse events in ＂Chiken＂clinical trials, but not in clinical trials specified under the Clinical Trials Act 2017. This paper clarifies the principal investigator's responsibility for reporting under the three laws related to clinical trials: the Pharmaceuticals and Medical Devices Act, the Clinical Trials Act, and the Act on the Safety of Regenerative Medicine. Report items were explained and summarized in a table. The paper also separately covers trials under other frameworks, such as the Ethical Guidelines for Medical and Health Research Involving Human Subjects. The paper will therefore help principal investigators to better understand their responsibilities and manage safety information in clinical trials under various frameworks in Japan. The paper also discusses some current issues that still need resolving.