Drug Evaluation Committee 2008-32 Necessity of Pharmacist Participation in Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: Mar. 2009
Question
According to GCP Article 28, Paragraph 1, Operational Notification 1, "The Clinical Trial Review Committee shall review the clinical trial from the ethical, scientific, medical and pharmacological viewpoints..." This means that the pharmacist must be a member of the Clinical Trial Review Committee. Does this mean that a pharmacist is required to be a member of the Clinical Trial Review Committee? Or, is it a problem if there is a physician on the committee?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the composition of the Clinical Trial Review Committee, it is essential that the requirements listed in Article 28, Paragraph 1 of the GCP are met.
The guidance on this section only stipulates that "a clinical trial review committee shall consist of an appropriate number of members who have the qualifications and experience necessary to discuss and evaluate the clinical trial from ethical, scientific, medical and pharmacological perspectives, and who can maintain such qualifications and experience as a committee as a whole. It does not specify that the participation of qualified pharmacists is mandatory as long as the committee members are capable of deliberation and evaluation from the medical and pharmacological viewpoints. Therefore, as long as the investigational study review committee's organizer judges that the committee is "capable of deliberation and evaluation from a medical and pharmacological perspective," it is not required to have a qualified pharmacist on the committee. However, in order to discuss and evaluate the investigational drug and protocol from medical and pharmacological viewpoints, it is desirable to include physicians and pharmacists as members of the committee.