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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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.
Keywordsbiomarker genomics pharmacogenomics global sample handling, genetics global regulations local regulations sample coding exploratory research
- Implementation of Pharmacogenomic Sample Collection in Clinical Trials
- Book Title
- Pharmacogenomics and Personalized Medicine
- pp 27-54
- Print ISBN
- Online ISBN
- Series Title
- Methods in Pharmacology and Toxicology
- Series ISSN
- Humana Press
- Copyright Holder
- Humana Press
- Additional Links
- global sample handling, genetics
- global regulations
- local regulations
- sample coding
- exploratory research
- Industry Sectors
- Nadine Cohen (1)
- Editor Affiliations
- 1. Johnson and Johnson Pharmaceutical Research and Development, L.L.C.
- Author Affiliations
- 2. Johnson and Johnson Pharmaceutical Research and Development,, L.L.C., 1000 Route 202,, Raritan, 08869, NJ
- 3. Department of Pharmacogenomics, Johnson and Johnson Pharmaceutical Research and Development, L.L.C., Raritan, NJ
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