Drug Evaluation Committee 2017-61 Providing Adverse Event Information for Subjects Withdrawing Consent
Related classification: Adverse drug reaction reports
Date of first publication: February 2018
Question
There is a case in which a sponsor has requested to collect information on adverse events that occurred after the withdrawal of consent from a patient who withdrew consent to participate in a clinical trial.
When the patient withdraws consent, we confirm the patient's desire to withdraw consent, including follow-up (the trial is an anticancer drug trial and there is a survival study), and we record this in the patient's medical record. The patient has completed a withdrawal of consent form for the trial and has been given the option of withdrawing consent for the follow-up study as well. The patient in question is a distant patient who is no longer able to come to our hospital due to deterioration of his primary illness, so the attending physician confirms his intention to withdraw consent by phone and records it in his medical record.
The sponsor said that even if the patient had withdrawn his consent, he would still like to collect adverse event information as far as the information obtained by the site through routine medical care is concerned, because reporting of adverse reactions is obligatory.
The investigator and the clinical trial office believe that it is unethical to provide subsequent information on a patient who has withdrawn consent, and they are not allowed to provide information on the patient in question. In response, the sponsor has requested that we revise the explanatory document, stating that there will be no problem in collecting information on adverse events after withdrawal of consent if we state in advance in the explanatory document to the subject that we may collect information on subsequent adverse events even if the subject withdraws consent including follow-up surveys and obtain consent.
We believe that there is a problem with providing the sponsor with subsequent information on a patient who has withdrawn consent, but is the above request from the sponsor appropriate under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the case of your question, the subject's intention to withdraw from the clinical trial was confirmed when the subject became unable to visit the investigational site, and it was confirmed at that time that the subject would not cooperate in future follow-up surveys as well.
Since the subject is unable to come to the hospital, we believe it is one way to collect safety information to the extent possible by telephone and provide it to the sponsor. In such cases, the importance of collecting safety information as part of a clinical trial must be fully explained to the subject and consent for the collection and provision of information must be obtained. . is of paramount importance and should take precedence over the interests of science and society. In light of this, we believe that the sponsor has no choice but to abandon this method of information collection.
If a subject were to receive medical information from another hospital where the subject is currently attending, the other hospital would have to clarify the purpose of use of the information and collect the information after obtaining consent from the subject for the acquisition and provision to a third party of personal information requiring special consideration (Article 17, Paragraph 2 and Article 23, Paragraph 1 of the Personal Information Protection Law). (Article 17, Paragraph 2 and Article 23, Paragraph 1 of the Act on the Protection of Personal Information).
Therefore, unless the subject is willing to cooperate in the collection of information after withdrawal of consent, the sponsor is not allowed to collect safety information.
While the subject's will must be fully respected, the collection of safety information is also extremely important in the conduct of a clinical trial. We would like to ask for the utmost cooperation from the investigational sites in order to gain the understanding and cooperation of the subjects.