Drug Evaluation Committee 2014-55 Appointment of Sponsor Medical Expert as a Member of a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: April 2015
Question
If a member who is currently appointed as a member of a Clinical Trial Review Committee becomes a medical expert of one protocol to be conducted by one pharmaceutical company, is it acceptable for the member to continue as a Clinical Trial Review Committee member? This committee member also belongs to a department involved in the clinical trial.
Considering that a medical expert = the pharmaceutical company side, would it be better to remove him from the Clinical Trial Review Committee membership? Also, is there any problem even if the member is the head of a department involved in the clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
No. Officers or employees of the sponsor or other persons who have a close relationship with the sponsor may not participate in deliberations and voting concerning the sponsor's clinical trial (GCP Article 29, Paragraph 1). As stated in your question, the sponsor's medical expert is in a position to provide advice on medical issues related to the relevant clinical trial on the sponsor's side. Therefore, there is no problem for him to remain a member of the Clinical Trial Review Committee, but he cannot participate in the deliberations and voting on the clinical trial for which he serves as a medical expert.