Drug Evaluation Committee 2008-31 Necessity of Review of Subject Referral Request Letter by Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: Mar. 2009
Question
In the case of a clinical trial being conducted at Medical Institution A, if the investigator of the clinical trial issues a letter to a physician at another medical institution who is a friend of the investigator and plans to receive referrals from potential subjects, does the letter and procedure still fall under the "subject recruitment procedure" stipulated in GCP and require approval by the Clinical Trial Review Committee? Is this still the same as the GCP's "subject recruitment procedure" and requires the approval of the investigational committee?
Contents of the letter
Letter from a clinical investigator to a physician acquaintance
- The fact that a "clinical trial" is being conducted at Hospital A
- Target disease
- A brief description of the selection criteria for the clinical trial
- A request for referral of patients who may be eligible for the clinical trial
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the recruitment of subjects for clinical trials, the Ministry of Health and Welfare, Pharmaceutical Safety Bureau, Surveillance and Guidance Division notified "Handling of Information Provision for the Recruitment of Subjects for Clinical Trials" in the Pharmaceutical Affairs Bureau, Pharmaceutical Affairs Bureau, No. 65 dated June 30, 1999. This subject recruitment is based on one of the recommendations of the "Study Group for Smooth Promotion of Clinical Trials," "a. Information Provision Activities for Subject Recruitment. The main purpose of this notice is to provide information to subjects in the implementation of individual clinical trials, and it was recommended that the public be given the opportunity to access information on individual clinical trials both inside and outside of the implementing medical institution.
The case in question seems to fall under the provision of information on clinical trials to medical institutions outside the implementing medical institution, not information provision activities for subjects who are considered to be the subjects of the clinical trial, Therefore, we believe that it is not necessary to obtain approval from the Clinical Trial Review Committee.
However, whether or not the provision of information to parties other than the site of the clinical trial constitutes subject recruitment depends on the content of the information provided and how it is used at the site of provision. Therefore, it is recommended that the necessity of review by a clinical trial review committee be determined, taking into consideration whether detailed information about the clinical trial will be explained to patients at the site and whether any remuneration will be paid to the medical institution (physician) referring the subject.
In addition, the clinical trial agreement and/or protocol usually includes a cautionary statement to the effect that "information may not be disclosed to a third party without the prior consent of the sponsor," and the investigator is obligated to maintain confidentiality. Therefore, we believe that prior agreement with the sponsor is necessary for "sending a letter (disclosing information) to an acquaintance physician" from this perspective.