Drug Evaluation Committee 2009-05 How to enter "Anticipated Quantity of Investigational New Drugs to be Delivered per Investigator Site" in the Notification of Clinical Trials
Related classification: Other
First published: Jul. 2009
Revised publication date: March 2021
Question
The following information is provided in the Notification of Clinical Trials (No. 0831-10, issued on August 31, 2020 by the Director, Drug Evaluation and Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare) regarding the "information on the planned quantity of investigational drug to be delivered" and the "planned number of Investigator Site subjects" in the notification of clinical trials.
(5) Matters per Investigator Site
... (Omitted)...
(4) Quantity information on investigational new 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 subjects at Investigator Site
In the Notification of Clinical Trial Plan or Notification of Changes to Clinical Trial Plan, the number of subjects (including the study drug group and control drug group) to be studied at each Investigator Site should be entered. The number of subjects (including the study drug group and control drug group) per site should be entered.
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 investigational drug (placebo) in the observation period shall be allocated to 10 subjects. (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?
JPMA's Opinion
(4) Quantitative Information on Investigational New Drugs, Devices Equivalent to Investigational New Drugs, and Products Equivalent to Investigational New Drugs," in this notice (Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, Director, Drug Evaluation and Management Division, August 31, 2020, Pharmaceutical and Pharmaceutical Affairs Bureau), it is stated that "an appropriate quantity should be issued in view of the dosage and administration and the expected number of subjects. Therefore, it is considered that the expected number of subjects per Investigator Site should be described for (5), and the quantity of investigational drug for use according to this expected number of subjects should be described for (4). 5.
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 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
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.