Pharmacogenetics, clinical trials

Under What Circumstances Can a "Pharmacogenetic Clinical Trial"... 

Shi MM et al. Pharmacogenetic Application in Drug Development and Clinical Trials. Drug Metabolism Disposition 2001 29 591-595. 

Rioux, P, "Clinical Trials in Pharmacogenetics and Pharmacogenomics Methods and Applications," Am. J. Health-System Pharm., 57, 887-898 (2000). 

Pharmacogenetics provides a rational framework to minimize the uncertainty in outcome of drug therapy and clinical trials and thereby should significantly reduce the risk of drug toxicity. The reader is referred to the Internet sources in Table 20.1 for more details on pharmacogenetics and drug development. Potential improvements in patient inclusion criteria will be addressed later in this chapter. 

How Will Conducting a Clinical Trial in a Pharmacogenetically Defined Subset of Patients Influence the Collection of Adequate... 

A major goal of pharmacogenetic and pharmacogenomic analyses in early-phase clinical studies is to identify subpopulations of subjects with an improved safety and efficacy profile. However, there are various views on how pharmacogenetics and pharmacogenomics could be used in the design of clinical trials. Some examples are as follows ... 

In most cases, there appears to be no overarching ethical reason to exclude certain subsets of patients from pharmacogenetic-based clinical trials, even those who may be at increased risks of a particular toxicity. However, each situation would need to be considered... 

Cardon LR, Idury RM, Harris TJ et al. Testing drug response in the presence of genetic information sampling issues for clinical trials. Pharmacogenetics 2000 10 503-510. 

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