Pharmacogenetics
Introduction
3.1 In this chapter, we consider ethical, legal and regulatory issues raised by the application of pharmacogenetics in the research and development of new medicines. We examine the implications for the conduct and cost of clinical trials. Although there is not yet agreement on the extent to which pharmacogenetic testing will influence the development of new medicines, it is clear that some clinical trials already involve collecting genetic information for the purposes of identifying subgroups of patients who are more likely to suffer adverse reactions, or to respond well to particular treatments. We consider likely trends in the use of pharmacogenetics in clinical trials, and examine the implications for obtaining consent from research participants and the use and storage of DNA samples for pharmacogenetic research.
3.2 It should be borne in mind that the application of pharmacogenetics has the potential to bring substantial benefits to patients. Improving the safety and efficacy of medicines would be of great value, not only to individual patients, but also to society. The following discussions should be viewed in this context. It is important to articulate and to respond to legitimate concerns so that the benefits of pharmacogenetics may be realised and potential problems minimised.