Protocol

Pharmacogenomics and Personalized Medicine

Part of the series Methods in Pharmacology and Toxicology pp 27-54

Implementation of Pharmacogenomic Sample Collection in Clinical Trials

  • Deborah Sokol RicciAffiliated withJohnson and Johnson Pharmaceutical Research and Development,
  • , Monique FrancAffiliated withDepartment of Pharmacogenomics, Johnson and Johnson Pharmaceutical Research and Development, L.L.C.

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Abstract

This chapter is intended to provide an overview of the operational considerations and potential obstacles that can be anticipated during the implementation of pharmacogenomic research in clinical trials. Particular attention is given to the elements of the protocol and of the informed consent and the considerations for collection of different sample types on a global level. The goal is to provide the reader with an appreciation for the study design elements on an operational level rather than on a scientific or statistical study design level. Educational efforts by various working groups to harmonize global standards are also outlined and will provide the reader with an overview of the ongoing efforts to promote global genomic research in the present day.

Keywords

biomarker genomics pharmacogenomics global sample handling, genetics global regulations local regulations sample coding exploratory research