Drug Evaluation Committee 2009-56 Provision of safety information to subjects assigned to a control drug
Related classification: Obtaining consent
First published: April 2010
Question
In an open-label, randomized, two-arm study (approved anticancer drug monotherapy group vs. approved anticancer drug + molecular-targeted drug combination therapy group) in which a molecular-targeted drug, the study drug, was added to an approved anticancer drug, the consent document was revised due to additional safety information of the study drug.
At that time, the only subjects in the clinical trial at our hospital were those who had been assigned to the target group (approved anticancer drug monotherapy group), so the investigator and sponsor did not require re-consent because the information would not affect the subject's intention to continue the trial.
Question 1
If the subject is in the control group, is it not necessary to provide information on the investigational drug?
Question 2
At our hospital, we revised the consent document based on this information. If we decide not to obtain re-consent, would we need to keep some kind of record in the hospital?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 54, Paragraph 1 of the GCP states that "When a clinical investigator obtains information that is deemed to influence the subject's decision to continue participating in a clinical trial, the investigator must immediately provide the subject with the information, record it in writing, and confirm whether the subject will continue to participate in the clinical trial. The regulations stipulate that "the physician shall immediately provide the subject with such information, record it in writing, and confirm whether the subject continues to participate in the clinical trial. The regulation also stipulates that "the information shall be provided immediately to the subject, and this information shall be documented in writing.
Answer 1
The continuation of the clinical trial due to this new safety information is based on the assumption that the clinical trial review committee has already approved the continuation of the clinical trial, the subject understands that the subject is receiving a drug that is not related to the safety information (this condition is satisfied because the trial is open-label), and furthermore, the new safety information does not affect the subject's willingness to continue the clinical trial. Furthermore, if the investigator judges that this safety information will not affect the subject's intention to continue the clinical trial, and the sponsor agrees to this judgment, then there is no problem with not providing the subject with the information.
Answer 2
The reason why the investigator decided not to provide the subject with new safety information and re-consent in writing (i.e., the subject meets the above conditions) can usually be explained from the source documents, so there is no need to make any separate record.