Drug Evaluation Committee 2005-16 Participation in Clinical Trials of Subjects During Follow-up Period in Other Clinical Trials
Related classification: Other
Date of first publication: Mar. 2007
Question
I would like to know how to deal with subjects who have participated in a clinical trial before and are in the follow-up period at the time of starting the trial.
In my opinion, even though it is a follow-up period, it is the duration of the clinical trial, so I considered the follow-up period to be a withdrawal of consent, and I thought that I would not provide any further information once the new consent was received.
However, I have heard that there are cases where two companies share the same subject's information when the follow-up period is for adverse events from a previously participated clinical trial and the next treatment has not been started, but only consent was given. (Monitoring was conducted during the same time period)
Also, if the company wishes to receive only information on whether the subject is alive or not, since there is no need to monitor only to confirm survival, we would appreciate it if you could tell us what kind of response the implementing medical institution would be able to provide.
JPMA's Opinion
Although the background of your question is unclear, I would like to state my opinion as follows as far as I understand it.
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(1)If the observation period after the end of administration (for example, 2 or 4 weeks) is predetermined in the study protocol, the study is ongoing and the patient is not allowed to participate in the next study.
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(2)If an adverse event observed during the post-administration observation period described in (1) above is to be followed up until normal values or symptoms stabilize according to the protocol, the event is usually considered to have a causal relationship during the post-administration observation period, and in this case, the event is also considered to be "undergoing a clinical trial. Therefore, the investigator is not allowed to participate in the next clinical trial. If the investigator determines that there is no need for follow-up for the event subject to follow-up, the trial will be terminated and the investigator will then decide whether or not to participate in the next trial based on the selection/exclusion criteria in the next study protocol.
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(3)Survival Confirmation Study
If this is to confirm survival only for reference purposes, apart from the duration of the clinical trial, we consider that the preceding clinical trial has been terminated and thus participation in a new clinical trial is not a problem.