Drug Evaluation Committee 2008-45 Provision of Clinical Trial Information to Patients before Clinical Trial Agreement
Related classification: clinical trial contracting procedures
Initial release date: Mar. 2009
Revised publication date: Mar. 2021
Question
Is it acceptable to explain a clinical trial to potential patients after approval by the Clinical Trial Review Committee and before a clinical trial contract is signed?
In one clinical trial, there was a record in the medical record that a physician verbally explained the trial to a potential patient before the contract was signed. Is it acceptable to explain the clinical trial to the patient before the contract is signed?
I believe that there are cases in which a clinical trial is introduced to a patient as part of his or her treatment. Also, please tell us if there are any points to note when discussing clinical trials with patients before signing a contract.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
A clinical trial starts after the head of the medical institution approves the implementation of the clinical trial based on the opinion of the Clinical Trial Review Committee and the conclusion of the contract. Therefore, physicians and CRCs should not explain to patients the specific details of the clinical trial or their participation in the clinical trial before the clinical trial contract is concluded. However, in recent years, information on clinical trials has become publicly available (e.g., JRCT, etc.), and if a patient asks about a specific clinical trial, it may be an unavoidable part of the physician's responsibility to explain the clinical trial and its schedule. In this case, there should be no problem in recording the answers to the patient's questions and providing informed consent after the contract is signed.
You are concerned about the fact that there is a statement that the potential subject patient was given a verbal explanation of the clinical trial, but since there are various possible explanations of a clinical trial, we suggest that you ask the doctor what kind of explanation was actually given to the patient.
We do not think there is a problem if the explanation is a general explanation about the clinical trial (e.g., the position of the clinical trial in drug development, the fact that the clinical trial involves research, etc.) or a general introduction to the fact that the clinical trial is being conducted for the patient's disease, but we think that an explanation that goes into the details of the clinical trial (the contents of the specific study protocol) would be problematic. We think that this is a problem.
Reason for revision of opinion
The National Institute of Health Sciences (NIHS), where Japic, UMIN, etc. can be searched together, has been added as a place where information can be disclosed. (March 2012)
Corrected the link to the information disclosure site. jRCT was added as a public information source. (March 2021)