Drug Evaluation Committee 2021-01 Provision of Clinical Trial Information to Patients Prior to Clinical Trial Agreement (Part 2)
Related classification: clinical trial contracting procedures
Date of first publication: Jul. 2021
Question
There is a case in which a patient with a rare disease, such as one contract case, was told about a clinical trial to the patient in advance before the Clinical Trial Review Committee or the contract, and the information was recorded in the patient's medical record. The content of the discussion was not about the clinical trial in general, but went into the details described in the clinical trial protocol.
If it is recorded in the patient's medical record that I talked about the contents of the protocol before the clinical trial review committee or contract, will the patient no longer be able to participate in the clinical trial?
I also read your question No. 2008-45. If I have gone into the content of the study protocol, will I no longer be able to obtain consent for a clinical trial? Is there any remedy?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As mentioned in 2008-45, it is not possible to start a clinical trial (recruitment of subjects, informed consent, screening, etc.) prior to obtaining approval from the investigational review committee and entering into a clinical trial agreement.
In the case of your question, it depends on the purpose and content of the clinical trial that the doctor talked to the patient about, but if the purpose was not to screen subjects or provide informed consent, but only to provide information about a "planned clinical trial" as one of the options for future treatment, then it is not necessary for the doctor to provide information about the clinical trial to the patient in such a way that it can be understood. If the purpose is not to screen subjects or provide informed consent, but only to provide information on a "planned clinical trial" as an option for future treatment, then it is possible for subjects to participate in the clinical trial if this is noted in the medical record, and after obtaining approval from the investigational review committee and entering into the clinical trial agreement, all necessary matters are explained using the approved explanation document, and appropriate informed consent is obtained. In addition, Article 52, Paragraph 2, Guidance 1 of GCP states that "investigators, subinvestigators and collaborators shall not coerce or exert undue influence on prospective subjects with respect to their participation in a clinical trial," and therefore, providing patients with information about a "planned clinical trial" is a good practice, Therefore, it is important to be careful that patients do not feel implicitly coerced into participating in a clinical trial by the provision of information about the "planned clinical trial" to them.