Drug Evaluation Committee 2013-03 Description of items for pharmacogenomics analysis in the explanatory document for test subjects
Related classification: Obtaining consent
Initial release date: May 2013
Revised publication date: March 2021
Question
We would like to discuss an exploratory biomarker and genetic study that will be conducted in conjunction with this study, as there are issues and discussions that arise at every Clinical Trial Review Committee meeting.
In conducting genomic and genetic analysis for the purpose of searching for disease-related genes, etc., which is not related to the evaluation of the investigational drug in question, the sponsor has prepared an explanatory document for the subjects regarding genomic and genetic analysis separately from this clinical trial. Since the analysis items for genomic/genetic analysis had not been determined at the time of the start of the clinical trial, specific analysis items were not described in the explanatory document, but only that the analysis items had not been determined.
During deliberations at the Clinical Trial Review Committee, it was stated that "If the items to be analyzed are defined while specimens are stored for several decades after approval, approval by the Clinical Trial Review Committee of the site and re-consent of the subject are required again." A committee member suggested that the explanatory document should clearly state, "If an item to be analyzed is specified while the specimen is stored for several decades after approval, approval by the investigational review committee of the site and re-consent of the subject are required. Is such a statement necessary in the explanatory document? Also, is it necessary to disclose the analysis items?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in your question, we believe that there will be no problem if you follow the approach described in Q2 of "Regarding Clinical Trials Using Genome Pharmacology" (September 30, 2008, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, Director of the Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Notification No. 0930007). In other words, if specific analysis items have not been decided at the time of obtaining consent for participation in genomic/genetic analysis, it is acceptable to state in the explanation document that genomic/genetic analysis unrelated to the evaluation of the investigational drug is planned and that specific analysis items have not been decided, along with the significance and purpose of genomic/genetic analysis. (It is acceptable to state in the explanatory document that genomic/genetic analysis unrelated to the evaluation of the clinical trial is planned and that specific analysis items have not yet been decided, along with the significance and purpose of genomic/genetic analysis.) When the analysis items have been determined, the research organization for the genomic/genetic analysis in question (with the sponsor functioning as the responsible party) will prepare a research plan and obtain approval from the ethics committee established in accordance with the "Ethical Guidelines for Life Science and Medical Research Involving Human Subjects," which will be reviewed again by the investigational review committee of the medical institution conducting the study. Therefore, there is no need to review the research plan again at the investigational review committee of the medical institution, and there is no need to obtain consent again from the subject.
Reasons for the Opinion Revision
Biomarkers in the development of pharmaceuticals or biotechnology-applied drugs: Guidelines for the description of usage, composition and format of materials in documents for eligibility confirmation" (February 20, 2011, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Director, Safety Measures Division, Pharmaceutical and Food Safety Bureau, Pharmaceutical and Food Safety Bureau, Notification No. 0120-1), "Guidelines for the collection of genomic samples and handling of genomic data" (February 20, 2011, Pharmaceutical and Food Safety Bureau, Notification No. 0120-1) (Notification of the Director, Drug Evaluation and Control Division, Pharmaceuticals and Food Safety Bureau, Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0120-1) and "Ethical Guidelines for Life Science and Medical Research Involving Human Subjects" (Notification of the Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry, Notification No. 1, 2021). The questions and opinions have been revised accordingly.