Drug Evaluation Committee 2011-15 Concurrent Advisory Positions for Sponsors by the Heads of Clinical Research Institutes
Related classification: Other
First published: Aug 2011
Question
There are specific toxicities (e.g., cardiac and skin disorders) of concern for concomitant drugs in Phase I anticancer trials. In order to properly evaluate such toxicities, we are planning to request an advisor to advise the sponsor on the design of the study protocol (measurement items and timing) and interpretation in case such toxicities occur during the study.
If the advisor is the head of the site where the clinical trial is being conducted (e.g., cardiac function/dermal toxicity), would it be a problem under GCP to request him as an advisor? The investigator at the site is a different physician from the director.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
I would like to express my opinion based on my understanding that the advisor in question is a "medical expert.
Medical experts are in a position to advise the sponsor on medical issues related to the clinical trial, as stated in GCP Article 4, Paragraph 2, Guidance 3: "The sponsor shall appoint a qualified medical expert to promptly advise the sponsor on medical issues related to the clinical trial. Therefore, we believe that it is problematic for a medical expert to serve as the principal investigator, coordinating investigator, and efficacy and safety evaluation committee member at the same time (please refer to our previous opinion 2010-32 ).
However, since the head of the medical institution for the clinical trial in question is not in a position to directly conduct the clinical trial, we believe that it is basically acceptable for a medical expert to concurrently serve as the head of the medical institution. However, if there is a risk of interfering with the work of the head of the site or affecting the work of the investigator, the medical specialist should not serve concurrently (or the site should not be selected as the site to which the investigator is to conduct the trial).