Points to Consider to Collect Genomic Samples in Clinical Trials During Drug Development

Abstract

ICH E18 was enacted to provide harmonised principles of genomic sampling and management of genomic data in clinical studies, and to encourage genomic research within clinical studies. In Japan, it was issued in January 2018. Comprehensive genomic sampling is encouraged during all clinical drug development stages in the guidelines, of which widely usage such as investigation of biomarker assay methodology, causality with disease, drug sensitivities, and/or safety assessment, should be addressed in the informed consent. Furthermore, this guideline is hopefully enhancing worldwide genomic data integration. However, some genomic data is legally defined as privacy information in Amended Act on the Protection of Personal Information by Japanese Government. Therefore, clinical study sponsors need to provide much further detailed information regarding the genomic sampling and analysis for study participants in clinical studies in Japan. For providing solution those issues, the Japan Pharmaceutical Manufacturers Association published update of the “Points to Consider for Pharmacogenomics in Clinical Studies of Pharmaceuticals (Preliminary version)” published in 2008 and renamed as “Points to consider to collect genomic samples in clinical studies of Pharmaceuticals” in 2018. In this article, the major revisions would like to be outlined, including of deletion of previous categories of genomic analysis, updates of anonymization procedures, and recommends of informed consents documentation.