Considerations for Conducting Clinical Trials Involving the Collection of Genomic Samples in Drug Development

In recent years, the effective use of genomic data in drug development is increasingly expected for drug discovery and for the provision of optimal treatments for individual patients.

In 2008, ICH E15 Guideline "Glossary of Terms in Pharmacogenomics of Genomics" was published, and in 2011, ICH E16 Guideline "Biomarkers: A Guide for Qualification in the Development of Pharmaceuticals or Biotechnology-based Medicines" was published. Biomarkers in the development of pharmaceuticals or biotechnology-applied medicinal products: guidelines for the description of usage, composition and format of documents for qualification" was published in 2008, and the ICH E18 guideline "Collection of genomic samples and handling of genomic data" issued in January 2018, it is expected that the collection of samples with the intention of obtaining genomic data in clinical trials will further increase. The ICH E18 guideline "Collection of Genomic Samples and Handling of Genomic Data" issued in January 2018 further increases the number of clinical trials in which samples are collected with the intention of obtaining genomic data. On the other hand, the revision of the Act on the Protection of Personal Information has brought about new changes in the environment for the use of genomic data in Japan.

In light of these circumstances, the Drug Evaluation Committee has prepared "Considerations for Conducting Clinical Trials Involving Genomic Samples in Drug Development", a completely revised version of the "Considerations for Conducting Pharmacogenomics in Clinical Trials of Pharmaceutical Products (Tentative Version)" published in 2008. With the publication of this document, the tentative version published in 2008 will be discontinued.

We will continue our efforts to promote the use of genomic data in clinical trials, and we ask for your continued support in this endeavor.

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