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Ethical perspectives on pharmacogenomic profiling in the drug development process
1Clinical Ethics Center, Memorial Medical Center, Southern Illinois University School of Medicine, 701 North First Street, Springfield, Illinois 62781-0001, USA. aissa@siumed.edu
Nature Reviews. Drug Discovery
|July 18, 2002
Summary
Pharmacogenomics, the study of how genes affect drug response, is advancing rapidly. This analysis explores its impact on drug development, clinical trials, and societal risks, offering recommendations for future integration.
Area of Science:
- Pharmacogenomics and drug development
Background:
- Pharmacogenomics studies genetic variations influencing individual drug responses.
- The field is rapidly advancing, presenting opportunities for drug development.
Purpose of the Study:
- To critically analyze the impact of pharmacogenomics on drug development.
- To discuss key issues including clinical-trial design, subject stratification, social risks, and economic concerns.
Main Methods:
- Critical analysis of pharmacogenomics integration in drug development.
- Examination of four specific areas: clinical-trial design, subject stratification, social risks, and economic concerns.
Main Results:
- Pharmacogenomics significantly impacts clinical-trial design and practice.
- Identifies new social and economic considerations associated with pharmacogenomics.
Conclusions:
- Pharmacogenomics offers potential for optimized drug development.
- Recommendations are provided for addressing challenges and regulatory needs in pharmacogenomics-based trials.