Drug Evaluation Committee 2011-15 Appointment of an Advisor to the Sponsor by the Head of Investigator Site
Related classification: Other
First published: August 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 Investigator Site (e.g., cardiac function/dermal toxicity), would it be a problem under GCP to ask him or her to act as an advisor? The investigator at the Investigator Site is a different physician from the Director.
JPMA's Opinion
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 director of the Investigator Site in question is not in a position to directly conduct the clinical trial, basically, we believe that it is acceptable for the medical specialist to serve concurrently. However, if there is a risk of interfering with the work of the head of the Investigator Site or affecting the work of the investigator, the medical specialist should not concurrently serve as the head of the Investigator Site (or the Investigator Site should not be selected as the site for the clinical trial).