Clinical Trials Act and ethical guidelines 

On May 31, 2024, we held the 1st Academia Clinical Development Seminar online inviting Dr. Kyoko Yaono from Tokyo Medical and Dental University to speak on Clinical Trials Act and ethical guidelines.

The Clinical Trials Act was reviewed in 2021, and a summary was published in June 2022. Based on the contents of this summary, the National Diet of Japan is currently planning to debate amendments to the law.

In this lecture, she clearly explained the Clinical Trials Act and ethical guidelines using some case examples.

First, she explained the applicability of the Clinical Trials Act. "Clinical trials" is defined as research conducted by administering or using drugs, etc. to humans to clarify the efficacy or safety of drugs, etc. The following are generally not subject to the Clinical Trials Act.

- Health foods, welfare equipment

- Those based on the Pharmaceuticals and Medical Devices Act

- Those that do not involve evaluation of drugs, etc.

- Those that are not administered or used on humans

- Those that do not involve medical procedures

- Observational studies

On the other hand, items sold as foods under the name of supplements or items containing their ingredients are considered to be "pharmaceuticals" if they are intended to be used for the treatment of diseases, etc. Therefore, we need to conduct clinical study under clinical trial act, when we use these items, she described.

Next, she explained the Ethical Guidelines for Medical and Health Research Involving Human Subjects. Among the items listed above, those except for based on the Pharmaceuticals and Medical Devices Act are covered by the ethical guidelines. She also explained the concepts of terms in the guideline such as "existing samples/information," "personal information, pseudonymized information, and anonymously processed information."

This seminar was extremely valuable as it addressed the real-world challenges researchers encounter in clinical research. There was an active Q&A session with the participants and the seminar ended in great success.

The next Academia Clinical Development Seminar will be held on Friday, July 26, 2024, and Dr. Nae Nakamura from the Osaka Business Development Agency will be invited to give a lecture.

We look forward to your participation.