Drug Evaluation Committee 2012-47 Necessity of Email Review of Subject Referral Requests by Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
First published: March 2013
Question
We have decided to recruit subjects for a clinical trial in which it is difficult to incorporate subjects (small patient population).
The method is for the responsible physician to send a document attached to an e-mail to physicians at other medical institutions who are on the mailing list (presumably not intended for the general public).
The document includes a statement that subjects are being recruited, the title of the clinical trial, characteristics of the investigational drug, an overview of the trial, participation criteria, and contact information for the responsible physician.
(It also includes a statement that the sponsor will bear the costs of tests and drugs necessary for the clinical trial.)
(Permission for the contents of the site has been obtained from the sponsor.)
I thought about this in reference to the past question and opinion collections 2008-31, 2011-41, and 2011-42,
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(1)Whether subject recruitment via physician-to-physician e-mail does not require IRB deliberation
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(2)Whether IRB deliberation is also unnecessary for the content of this document
We would like to receive the opinion of the Pharmaceutical Cooperative Association. Incidentally, the sponsor is of the opinion that IRB review is unnecessary, while our hospital is of the opinion that IRB review is necessary.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 32, Paragraph 1 of the GCP stipulates what the investigational review committee is to review, including "materials related to procedures for recruiting subjects (advertising, etc.)" (Guidance 2 (3), Paragraph 1 of the same article). Thus, the Trial Review Committee is not limited to subject advertisements alone, but also considers the recruitment procedure itself as a subject of review.
In the case of Opinion 2008-31, the information on the investigational drug and clinical trial provided to physicians at other medical institutions was quite limited, and I expressed my opinion on the assumption that the case could be handled within the scope of patient referral in general practice, not subject recruitment. On the other hand, in the case in question, detailed information is provided to physicians at other medical institutions, including the characteristics of the investigational drug, an overview of the clinical trial, participation criteria, and cost burdens for subjects, so we could not determine whether it is appropriate to treat this case in the same way as the previous case.
Depending on how much information physicians at other medical institutions provide (or are able to provide) to potential subjects (hereinafter referred to as "potential subjects") and whether they are able to show potential subjects documents provided by the investigator, it is possible that the provision of such information may be an inducement for potential subjects to participate in the clinical trial and that it may not be appropriate for them to be recruited. This may be an inducement for potential subjects to participate in the clinical trial and may constitute recruitment of subjects. Therefore, it is recommended to check the above points before deciding whether or not to subject the information to review by the Clinical Trial Review Committee.