Drug Evaluation Committee 2024-37 Availability of Data on Patients Withdrawing Consent for Clinical Trials
Related classification: Obtaining consent
Date of first release: December 2024
Question
If a clinical trial is terminated in the middle (including withdrawal of consent), is it necessary to confirm the subject's consent to use the data at the time of termination, even if the subject agreed at the time of consent acquisition that the data obtained up to that point would be used?
According to the ICH Privacy Statement, "For clarifications sake such withdrawal will, however, not affect the lawfulness of processing based on consent before its withdrawal. Therefore, we believe that there is no problem in using data collected based on consent even if the study is terminated (consent withdrawn), and in particular, we believe that all AE information should be used to verify the safety of the investigational drug.
On the other hand, if the subject has the intention to withdraw the "consent to use the data obtained up to that point" itself at the time of obtaining consent, we believe that it is also difficult to use the data without regard to that intention. Therefore, do we need to re-confirm with the subject at the time of discontinuation that we will use the data obtained up to that point?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the subject's consent is obtained by clearly stating in the explanation document that "even if the subject withdraws consent, the data obtained up to the time of withdrawal of consent will be used," we believe that there is no problem with using the data obtained up to the time of withdrawal of consent as part of the consent category. Therefore, there is no need to voluntarily confirm the subject's consent again. However, if the subject requests to withdraw "consent to use data obtained up to that point," consideration of "protection of the subject's human rights" is of paramount importance, as stated in Article 1 Guidance 2 of the GCP. However, depending on the timing of the request, it may be difficult to delete the data, so it is necessary to explain this to the subject and re-confirm with the subject the use of the data up to that point. Therefore, it is necessary to explain to the subject to that effect and ask the subject to confirm again about using the data until then.