Drug Evaluation Committee 2005-14 Change of Responsible Clinical Investigators (Part 3)
Related classification: Principal investigators, subinvestigators, etc.
Date of first publication: Mar. 2007
Question
This is a question regarding the actions to be taken after the transfer (resignation) of a clinical investigator.
We have already answered a similar question in " Transfer/Replacement of Clinical Investigator (Part 1)," but we would like to know more about it.
Questions
Is it acceptable for a physician who does not specialize in the clinical trial to be appointed as a principal investigator?
Background of the question
In a clinical trial without an investigator, the principal investigator is planning to retire from the hospital at the end of March.
However, at this point, it has not been decided whether or not a replacement physician in that department is scheduled to arrive.
If the successor does not arrive on April 1, the position of the physician in that department will effectively become vacant, and there will be no candidate physician to serve as the principal investigator.
As for the clinical trial, all subjects have already been enrolled and only the case report form remains to be filled out.
We fully understand that we will work to complete the CRF by the end of March, but the actual clinical trial period will continue into the next fiscal year, and we still think it is essential to register a principal investigator in order to respond to SDV and various inquiries.
In this case, is it possible to register a physician outside of the clinical trial specialty as a principal investigator until a successor physician arrives?
However, in some cases, it is possible that the trial may be completed with a non-expert as the principal investigator before a successor physician in the specialty area arrives, but is this still a problem?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As you know, the change of investigator is based on Articles 6 (Selection of medical institutions), 32 (Responsibilities of Clinical Review Committee), 35 (Requirements for medical institutions), and 42 (Requirements for investigators) of the GCP, etc. First, the sponsor selects the investigator, and if the investigator is judged to be qualified, the IRB is requested to deliberate on the change. If the IRB determines that the investigator is qualified, the sponsor requests the IRB to deliberate the matter, and if the IRB approves the request, the new investigator can conduct the clinical trial.
If there is an investigator, he/she is familiar with the clinical trial and would be suitable as a successor. However, if there is no subinvestigator, the planned use of the investigational drug, examination and observation have been completed, and the only remaining responsibility of the investigator is to write the case report form. Therefore, we believe that it is possible to obtain IRB approval for the investigator as the next best option if a physician who understands the area of the clinical trial and the protocol to some extent, even if his/her department is different from that of the investigator.
However, it is necessary to discuss the communication system for inquiries and confirmations to the predecessor investigator in advance with the investigator to be replaced, and to take measures in advance to ensure that necessary information is provided by the predecessor investigator.
However, it cannot be said that there is no problem in any case, so it is best to collect the case report forms as far as possible before the resignation of the current principal investigator.
In addition, the sponsor needs to conduct preliminary investigations on potential investigators and revise contracts, so we recommend that you consult with the sponsor as soon as possible.
In addition, in case the investigator is unable to fulfill his/her responsibilities for some reason, it is possible to have an IRB approve one of the subinvestigators to be the principal investigator in such a case in advance, and to include this in the contract. In the U.S., although it is not in the regulations, it is possible to have a co-principal investigator who acts on behalf of the principal investigator in addition to the principal investigator.