Drug Evaluation Committee 2007-09 Review by Clinical Trial Review Committee for participation in a clinical trial by welfare recipients
Related classification: Other
Initial release date: Jan. 2008
Revised publication date: December 2021
Question
I would like to ask one additional question in response to question No. 2007-07.
Regarding "Consideration for socially vulnerable groups will be mainly reviewed by the Clinical Trial Review Committee (GCP Article 32, Paragraph 1/Section 2, Operational Notification 1)," does this mean that problems will arise if the welfare subjects (socially vulnerable groups) are not reviewed in advance of entry? Even if the authorities were to pursue a case in which a subject was entered in spite of the fact that the above screening was not conducted, I feel that there would be no problem as long as the welfare office, investigator, and subject are in agreement with each other so that the subject is not disadvantaged. However, I am fully aware that such a view is not appropriate as a general view and that it is difficult for the Clinical Trial 119 Secretariat to answer. If you could respond to our question (even if it is a subjective judgment), we would be grateful to hear from you.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 32, Paragraphs 1 and 2, Guidance 1 of the GCP states that "The Investigational Review Committee shall protect the human rights, maintain the safety, and improve the welfare of all subjects. Particular attention should be paid to clinical trials that may involve subjects who are socially vulnerable.
Therefore, it is considered necessary to confirm that there are provisions in the protocol that give sufficient consideration to ethics (human rights), safety, and welfare for subjects in clinical trials or medical institutions that may enter socially vulnerable persons as characteristics of the investigational new drug or as target patients.
On the other hand, for welfare recipients (hereafter referred to as "the subject"), receipt of the burden reduction allowance may be grounds for exclusion from the application of welfare benefits or reduction of welfare payments. In addition, the uninsured combined medical care cost system does not apply in principle (Article 52, Paragraph 2 of the Public Assistance Law). Therefore, when the subject participates in a clinical trial, adjustments are required between the welfare office, the investigational site, and the subject with regard to the impact on the public assistance system and the method of cost sharing, Therefore, it is not necessary for a clinical trial review committee to review whether or not the subject can participate in a clinical trial, either individually or on a subject-by-subject basis.
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (July 5, 2027, Pharmacovigilance No. 0705-3).