1. In section 4.3.4 of the ICH E6 guidance, it states that a patient involved in
ID: 121775 • Letter: 1
Question
1. In section 4.3.4 of the ICH E6 guidance, it states that a patient involved in a clinical trial is not required to give a reason for withdrawing from the trial but that the investigator should make a "reasonable effort" to ascertain the reason. What do you think qualifies as a "reasonable effort," and is it ever necessary for a patient to give a reason for withdrawing from a trial?
2. What do you think of the fact that the ICH has a guidance on GCP but not GLP?
3. From your perspective, is it necessary for the ICH to develop its own GLP guidance? Why?
Explanation / Answer
It is very important to maintain data at every step of clinical trial. If a patient wants to withdraw in between the studies, there could be several reasons such as hesitation, adverse or side effect, transfer to other place etc. “Reasonable effort” to know whether the patients wants to withdraw but he/she may be ready to be contacted through mail, telephone etc. in such case, it will be helpful to collect data related to after effects or survival of patient after withdrawal. Also, there is a possibility that the patient just wants medication to be stopped and is ready to visit for other studies, or may be relocating and ready to communicate or visit timely. These possibilities will be very helpful during research. Therefore, an open discussion to know such type of condition may be termed as ‘reasonable effort’. On the other hand, it is not necessary for the patient to communicate any reason of withdrawal from trial. But a general discussion should be always open between patient and investigator.
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