Drug Evaluation Committee 2009-05 How to enter the "Anticipated Quantity of Investigational New Drugs Delivered per Site" in the Clinical Trial Notification Form
Related classification: Other
First published: Jul 2009
Revised publication date: Mar. 2021
Question
The following is a description of the "information on the planned quantity of investigational drug to be delivered" and the "planned number of subjects at each site" in the clinical trial notification (Notification of the Director, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, August 31, 2020).
5. items for each investigational site
... (Omitted)...
(4) Quantitative information on investigational drugs, devices and products used in clinical trials
The planned quantity of the investigational drug to be delivered (obtained) should be entered by type (dosage form and content).
(5) Number of planned subjects at each site
In the Notification of Clinical Trial Plan or Notification of Clinical Trial Plan Amendment, the expected number of subjects (including the study drug group and control drug group) per site should be entered. (2) Enter the number of subjects (including test and control drug groups) per site in the clinical trial plan notification or clinical trial plan amendment notification.
In the case of a study such as "screening period (observation period) → randomization (allocation) → DBT period (treatment period)," where placebo is administered to all subjects in the screening period and placebo or placebo or placebo is administered after allocation, and the dropout rate in the screening period is expected to be approximately 40%, the number of subjects to be treated with the study drug (placebo) in the observation period shall be 10. (placebo) for 10 cases and the investigational drug for 6 cases in the treatment phase, how should (4) and (5) in the clinical trial notification be described respectively?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
This notice (No. 10 of 0831, Notification of the Director, Drug Evaluation and Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, August 31, 2020) states that "(4) Information on quantities of investigational drugs, devices and products for clinical trials shall be provided in an appropriate quantity in consideration of dosage and administration and the expected number of subjects". Therefore, it is considered that for (5), the expected number of subjects per site should be stated, and for (4), the quantity of the investigational drug to be used in accordance with this expected number of subjects should be stated.
In practice, there may be several ways to describe the clinical trial notification in a case such as the one you are asking about. The placebo is an investigational drug, and the subjects enrolled in the observation phase are considered to be part of the clinical trial. It is considered necessary to clarify the concept of the target number of cases and the handling of cases in the observation period in the clinical trial protocol.
Reason for revision of opinion
Minor changes were made in accordance with the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020) and the Handling of Notification of a Clinical Trial Plan for a Drug by a Person Who Wants to Request a Clinical Trial (No. 0831-10 issued on August 31, 2020). 5.