Drug Evaluation Committee 2007-31 Agreement for a single clinical trial at two affiliated medical institutions (Part 2)

Related classification: clinical trial contracting procedures

Date of first publication: August 2008

Question

I have a question regarding the Pharmaceutical Manufacturers Association's (PMA) opinion on " Question No. 2007-08 " in Clinical Trial 119 Questions and Opinions.

When conducting diagnosis and testing for eligibility as a subject for a clinical trial, even if it is conducted at Hospital A or Clinic B, it is a natural procedure to do so after obtaining the subject's consent, and I think the thinking on this point should be handled in the same way as the content of the response from the Pharmaceutical Affairs Association. My questions are as follows.

Question 1

In the response to 1. and 2. of the Pharmaceutical Manufacturers Association's Opinion, 1. is classified as "when tests performed at Clinic B cannot be performed as part of routine medical care" and 2. is classified as "when tests performed at Clinic B are performed as part of routine medical care. What is the reason for the distinction between "within and outside the scope of routine medical care"?

Question 2

If Clinic B is also treated as a facility subject to clinical trial notification in accordance with the response to 1. in the opinion of the Pharmaceutical Association of Japan, please explain the matters that should be handled by the sponsor.

If Clinic B is treated as a facility subject to clinical trial notification, is it necessary to handle all clinical trial procedures (procedures before, during, and after the start of a clinical trial) at Clinic B in the same way as for a regular sponsor facility? That is,

Question 3

If Clinic B is the target site for clinical trial notification, what procedures and processes are unnecessary among "establishment of investigators at Clinic B," "deliberation by the site IRB," and other clinical trial procedures? What are the reasons for deeming them unnecessary? (Is it because we are a medical institution that does not administer investigational drugs?)

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Question 1

In normal medical care, tests necessary for the diagnosis of patients who come to the hospital are performed regardless of their participation in a clinical trial (within the scope of routine medical care). However, in addition to the tests in routine medical care, tests such as blood tests, urine tests, electrocardiograms, vital signs, and images will be performed to confirm the selection and exclusion criteria of subjects (outside the scope of routine medical care).

Among the tests stipulated in the protocol, tests that are outside the scope of routine medical care must be performed after consent is obtained.

In addition, with regard to tests that are mentally or physically invasive to the subject, even data conducted before consent can be used as data for a clinical trial if the allowable period of time before consent is specified in advance in the protocol to reduce the burden on the subject.

Questions 2 and 3

Since the aforementioned confirmation of eligibility for participation in the clinical trial and explanation of the outline of the clinical trial to patients visiting Clinic B are part of the activities stipulated in the protocol, Clinic B is subject to notification of the clinical trial as a medical institution under the GCP. In addition, the physician at Clinic B must include data up to the eligibility determination in the case report form, but since the clinical trial will be conducted jointly with Hospital A, his role does not necessarily mean that he must be the principal investigator.

However, as the current GCP does not anticipate a clinical trial conducted jointly by multiple medical institutions, as in this case, it is necessary to consult with the Pharmaceuticals and Medical Devices Agency (PMDA) in advance regarding the procedures and precautions in conducting the clinical trial. Therefore, we recommend that you consult with the Pharmaceuticals and Medical Devices Agency regarding the procedures and precautions in conducting a clinical trial.

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