Drug Evaluation Committee 2017-81 Review of Conflicts of Interest in Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
Date of first publication: June 2018
Question
In what specific cases is the review of conflicts of interest required in the deliberations of a Clinical Trial Review Committee?
In Article 32, Paragraph 1 and Paragraph 2, Guidance 2 (6) of the GCP, there is a provision that "other materials that the investigational review committee deems necessary (when there is collaboration with a company, materials related to conflicts of interest, etc.)" are to be reviewed by the investigational review committee. What exactly do you mean by "cases in which there is collaboration with a company"?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Cases requiring conflict of interest review are those in which the person conducting the clinical trial may benefit directly or indirectly from the success of the trial. In such cases, it is necessary to confirm in advance the possibility of the conflict of interest affecting the reliability of the clinical trial data. Examples include cases in which the investigator may benefit from the success of the clinical trial by owning shares in the sponsor or by owning all or part of the intellectual property rights of the product under development.
In addition, in the COI management guidelines of the Japan Medical Association (revised in March 2017), the following activities are included in industry-academia collaboration conducted by research institutions with companies, corporate organizations, and profit-oriented organizations (omitted) regarding medical research and are subject to COI reporting: joint research, contract research, technology transfer, technology guidance, research Please refer to the following list: joint research, commissioned research, technology transfer, technology guidance, institution-initiated venture companies, endowment funds, and endowed courses.