Drug Evaluation Committee 2022-13 Provision of Patient Information to the Sponsor Prior to Obtaining Consent
Related classification: Obtaining consent
Date of first publication: Sep 2022
Question.
In the protocol's exclusion criteria, it is stated that "if applicable, the Medical Monitor will make a decision on a case-by-case basis. As a sponsor, I am told that confirmation with the medical monitor can be done either before or after consent is obtained.As an institution, based on the risk of screening dropout after obtaining consent, we provided enough information not to identify the patient before explaining the clinical trial so that the medical monitor could respond at the time of explaining the clinical trial to the patient. However, we have been asked to provide more detailed information from the information we provided (e.g., current (prior to obtaining consent) dosage of concomitant medications, specific severity of patient complications, etc.).
Each piece of information requested by the requester is not specified in the protocol regarding its collection. Institutions are reluctant to provide detailed information that is not specified in the protocol, and even more reluctant to provide patient information prior to obtaining consent for a clinical trial.
Should the fact that such information is provided be explained in detail at the time of explaining the clinical trial, and should the information be provided after consent is obtained? Also, to what extent is it possible under GCP to provide information that is not specified in the protocol?
The Pharmaceutical Manufacturers Association's Opinion
We consider this to be a question regarding the following two points, and would like to express our views.1) Patient information provided to the sponsor prior to obtaining consent
Based on your question, there is a possibility that the information provided to the sponsor, such as the drugs used by the patient (the person who is to be the subject of the study) and the extent of his/her medical history, may fall under the category of sensitive personal information as defined in Article 2, Paragraph 3 of the Act on the Protection of Personal Information. In addition, under the Personal Information Protection Law, it is obligatory to obtain the consent of the individual in principle (Article 23, Paragraph 1 of the Personal Information Protection Law) when acquiring and providing to a third party personal information requiring special consideration, such as medical history. Therefore, we believe that careful consideration should be given to the content of information to be provided to the client prior to obtaining consent. If, as in the case of this question, the medical monitor is to determine the information of an individual patient (a person to be a subject), and if there is a possibility that the information may fall under the provision of personal information requiring special consideration, we believe that the information should be provided after obtaining consent from the patient (a person to be a subject) himself/herself. In addition, when confirming with the sponsor before obtaining consent, it is desirable to do so as a confirmation of interpretation of the study protocol, rather than as an inquiry regarding the inclusion of a specific patient.
2) Concept of providing information on matters not specified in the protocol
Regarding the collection of information on matters not specified in the protocol, ensuring the safety of subjects is a priority in all aspects of the clinical trial. Therefore, we believe that necessary information should be collected and shared among sites and sponsors, regardless of whether or not it is specified in the protocol. In addition, as stated in Article 21, Paragraph 1, Explanation 9 (9) of the GCP Guidance, monitors need to confirm that the investigators, etc. are including only eligible subjects in the clinical trial. Therefore, in order to confirm the eligibility of subjects, we may ask you to provide information that is not specified in the protocol, and we would appreciate your cooperation in such cases.
However, it would be desirable to specify in advance the items of information to be provided to the sponsor that can be assumed in the protocol and to include them in the explanatory documents.