Drug Evaluation Committee 2022-13: Provision of Patient Information to Clinical Trial Sponsors Prior to Obtaining Informed Consent
Related Category: Obtaining Informed Consent
Initial Publication Date: September 2022
Question
The protocol’s exclusion criteria state, “If applicable, the medical monitor will make a case-by-case determination.” As the clinical trial sponsor, we understand that we may consult with the medical monitor either before or after obtaining informed consent.Given the risk of patients dropping out of the screening process after consent is obtained, our institution has been providing information—at a level that does not identify the patient—prior to the clinical trial briefing, so that we can obtain the medical monitor’s response during the patient’s briefing.However, we are now being asked to provide even more detailed information based on the information we have already provided (e.g., dosage and administration of concomitant medications at the present time [before obtaining consent], the specific severity of the patient’s comorbidities, etc.).
The protocol does not specify requirements for collecting any of the individual pieces of information requested by the sponsor. As a site, we are reluctant to provide detailed information not specified in the protocol; moreover, we are even more reluctant to disclose patient information prior to obtaining informed consent for the clinical trial.
Should we explain in detail during the clinical trial briefing that such information will be provided, and should we provide it only after informed consent has been obtained? Furthermore, to what extent is it permissible under GCP to provide information not specified in the protocol?
Opinion of the JPMA
We interpret your inquiry as concerning the following two points and would like to offer our opinion.1. Approach to Patient Information Provided to the Clinical Trial Sponsor Prior to Obtaining Informed Consent
Based on the content of your inquiry, the information provided to the clinical trial sponsor—such as the medications being used by the patient (prospective subject) and the severity of their medical history—may constitute “sensitive personal information” as defined in Article 2, Paragraph 3 of the Act on the Protection of Personal Information.Furthermore, under the Act on the Protection of Personal Information, obtaining and providing “sensitive personal information”—such as medical history—to a third party generally requires the consent of the individual concerned (Article 23, Paragraph 1 of the Act on the Protection of Personal Information). Therefore, we believe that the content of information provided to the sponsor prior to obtaining consent requires careful consideration.In cases such as the one described in this inquiry, where a medical monitor is evaluating information regarding individual patients (prospective subjects), if the disclosure could constitute the provision of sensitive personal information, we believe the information should be provided only after obtaining consent from the patient (prospective subject) themselves.Furthermore, if confirmation is sought from the sponsor prior to obtaining consent, it is advisable to do so not as an inquiry regarding the enrollment of a specific patient, but rather as a confirmation of the interpretation of the clinical trial protocol.
2.Approach to Providing Information on Matters Not Specified in the Clinical Trial Protocol
Regarding the collection of information on matters not specified in the clinical trial protocol, ensuring the safety of trial participants takes priority in all cases. Therefore, we believe that the necessary information should be collected and shared between the site and the sponsor, regardless of whether it is included in the clinical trial protocol.Furthermore, as stated in Explanation 9(9) of Article 21, Paragraph 1 of the GCP Guidance, monitors must confirm that the principal investigator and others are enrolling only eligible subjects in the clinical trial. Therefore, in order to verify subject eligibility, we may occasionally request information not specified in the clinical trial protocol; we ask for your cooperation in such cases.
However, we believe it is desirable to specify in advance in the clinical trial protocol—and include in the informed consent document—the items of information that are likely to be requested from the sponsor.