Drug Evaluation Committee 2012-12 Conducting Inspections Using Investigational New Drugs

Related classification: Other

First published: June 2012

Question

At one medical institution in a clinical trial, an investigational drug was used for DLST* in addition to subject administration. Blood was drawn for DLST from subjects who showed allergic reactions during the clinical trial, and the investigational drug was added to the blood to identify the causal relationship of the event. However, this is only a test to determine the future treatment plan for the subject and not for research purposes.

The use of the above-mentioned investigational drug is not specified in the protocol or procedures. In addition, since the investigational drug is manufactured overseas, it is practically difficult to import it again for testing.

Question 1

In such a case, is it appropriate to "use the investigational drug for testing," which is not stipulated in the protocol, even though it is to examine the treatment plan for the subject? If it is not appropriate, what part is not appropriate and what should have been done?

Question 2

When blood is drawn from a subject for DLST, do you think that consent from the subject to perform the test is necessary? If so, is it essential that it be documented?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Question 1

Article 1, Guidance 2 (6) of the GCP stipulates that "Clinical trials shall be conducted in compliance with the protocol approved in advance by the investigational review committee. This means that the investigational new drug must be used in accordance with the investigational protocol. In other words, investigational drugs are supposed to be used only within the scope specified in the protocol, and cannot be used for any other purpose.

On the other hand, Article 45, Paragraph 3/4, Guidance 2 of the GCP states that "the head of the site and the investigator shall ensure that adequate medical care is provided to the subject for all adverse events that may cause clinical problems related to the clinical trial, both during the subject's participation in the trial and thereafter. The statement states.

There is generally no problem with the investigator or sub-investigator performing additional tests at his or her own discretion to determine causality of adverse events or to determine the course of treatment. However, since DSLT involves the use of an investigational drug for a purpose not specified in the study protocol, it is necessary to fully consider the necessity and appropriateness of such tests before deciding whether or not to perform them, and to discuss and agree on the necessity and appropriateness with the sponsor in advance.

If the DLST was performed prior to agreement with the sponsor because it was medically unavoidable in order to avoid an immediate risk to the subject, a document describing the action and the reason for it must be submitted immediately to the sponsor and the head of the site, in accordance with GCP Article 46, Paragraph 1.

Question 2

Under GCP Article 45 Paragraph 3/4 Guidance 2, "When the investigator or subinvestigator learns that medical treatment for an adverse event has become necessary, the investigator or subinvestigator shall inform the subject of this fact." Since the blood sampling for DLST is to ensure the safety of the subject, it is not necessary to obtain consent in writing as long as the subject is informed of the necessity of the test and consents to it in accordance with the above regulations. However, the final decision is subject to the judgment of the investigator and the agreement of the relevant medical institution.

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