Drug Evaluation Committee 2021-59 Wash-out before consent is obtained

As stated in the opinion in 2014-42, a Wash-out of a pre-treatment drug prior to obtaining consent constitutes an investigational activity. However, please provide your opinion on whether or not the following cases (1) and (2) constitute an investigational activity.

 

≪Background.

The potential subject's willingness to participate in a clinical trial was confirmed through preliminary explanation of the clinical trial (written consent was not obtained). The next visit to the hospital was set as the scheduled date for obtaining consent.

At the time of the preliminary explanation, we informed the subject that the clinical trial could not be started until 3 weeks after the start of the washout period because of the washout period of the previous treatment drug A.

 

≪Case 1: Subject started the Wash-out by him/herself≫.

After the prior explanation, the subject stopped taking the pre-treatment drug A, which the subject had been taking every morning, before the scheduled date of obtaining consent. Consent was obtained on the scheduled date, and the study was started 3 weeks after the last dose of the previous treatment drug A. There was no statement from the medical institution encouraging the subject to wash-out, and the change in dose was due to the potential subject's desire to participate in the clinical trial as soon as possible. The physician judged that there was no safety concern due to the fact that the subject did not take the previous treatment drug A.

 

≪Case 2: The subject voluntarily initiated Wash-out as a result of presenting options in accordance with the subject's wishes

During the preliminary explanation, the potential subject expressed a desire to participate in the clinical trial as soon as possible, so we informed the subject that he could stop taking the previous treatment A if he wanted to start the trial earlier (based on the physician's judgment that there were no safety concerns even if he stopped taking the drug). As a result, the subject stopped taking the pre-treatment drug A, which he had been taking every morning prior to the scheduled date of obtaining consent. Consent was obtained on the scheduled date, and the study was started 3 weeks after the last dose of the previous treatment drug A.

Even if the subject himself performed the Wash-out by his own judgment, it would be considered as an investigational act as in the case of 2014-42. We believe that both cases (1) and (2) are cases in which the subject's incorrect response was triggered by inadequate explanation of the clinical trial for the following reasons.

 

(1) This is a case in which a washout, which should have been conducted after obtaining written consent, was conducted before obtaining written consent due to the subject's self-decision, and the subject would not have stopped taking the previous treatment A due to self-decision if the clinical trial had not been explained, and the cause of this is considered to be an insufficient explanation of consent. The reason for this is considered to be inadequate explanation of the consent. 2.

 

2. that discontinuation of pre-treatment drug A prior to obtaining written consent is an act that does not enter into the compensation period of the clinical trial, and therefore, if a safety issue arises as a result of discontinuation of pre-treatment drug A, it is not covered by compensation and may cause disadvantage to the subject.

 

In order to avoid the situation described in questions 1) and 2), please provide sufficient explanation, questions and answers while confirming the subject's understanding using the explanation document approved by the Clinical Trial Review Committee in advance, even in the case of advance explanation, as well as in the case of explanation at the time of obtaining consent.