Drug Evaluation Committee 2010-01 Scope of Non-Expert Members of Clinical Trial Review Committees (Part 2)
Related classification: Clinical Trial Review Committee
First published: May 2010
Question
I have a question regarding the classification of expert/non-expert members of a clinical trial review committee. Would a dietitian be classified as either a professional member or a non-expert member?
Question 1
Article 28, Paragraph 1, Item 3 of the GCP states that "Among the committee members, persons other than those with expertise in medicine, dentistry, pharmacology, or other medical care or clinical trials must be included. In the Operational Notification 1, it is stated that "(2) At least one of the committee members must belong to a field other than natural sciences such as medicine, dentistry, or pharmacy." The operational notice 1 states "2) At least one of the committee members must belong to a field other than natural sciences such as medicine, dentistry, and pharmacy.
However, considering the specialized nature of dietitians, it could be considered that they do not fall under the category of "other persons with expertise in medical care or clinical trials.
Others believe that a dietitian is a professional committee member because of the medical content required to obtain such a certification.
Question 2
The question is if a dietitian is considered a "non-professional member".
We believe that a dietitian could be classified as a "technical committee member" for the "dietary effects" study and the "bioequivalence study postprandial administration" study due to his/her expertise. In such cases, would it be acceptable for the classification of committee members to change within one Clinical Trial Review Committee depending on the nature of the study being conducted?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 1, Paragraph 2 of the Dietitians Act, "A registered dietitian is a person who, under license from the Minister of Health, Labour and Welfare and using the name of dietitian, provides nutritional guidance necessary for the medical treatment of injured and sick persons, nutritional guidance for the maintenance and promotion of health requiring a high level of specialized knowledge and skills according to the physical condition, nutritional status, etc. of individuals, and nutritional guidance to a specified number of people. (2) A person whose business is to provide nutritional guidance to injured or sick persons, nutritional guidance for the maintenance and promotion of health that requires a high level of specialized knowledge and skills according to the physical condition and nutritional status of the individual, and meal service management that requires special consideration according to the physical condition, nutritional status, and use of users at facilities that continuously supply meals to a large number of people, and guidance necessary for improving nutrition at such facilities. The definition of a registered dietitian is as follows.
In addition, the National Examination for Registered Dietitians includes the subject "Structure and Function of the Human Body and the Origin of Disease" as part of its examination subjects.
As described above, a Registered Dietitian is in a position to promote medical care by maintaining knowledge of the body and disease and providing guidance to the sick and injured.