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| home > epc > spring 2003 > how to include genetic analysis in clinical trials |
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European Pharmaceutical Contractor
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The demand for genetic analysis in clinical trials is increasing. This is partly due to the growing realisation that understanding the genetic variation within a clinical trial population can improve the design, safety and outcome of the trial. A second major driver is the encouragement that the regulatory authorities, in particular the FDA, are giving to the inclusion of a pharmacogenomic element. For the pharmaceutical company or CRO wishing to incorporate a genetic analysis component there are now a number of service providers who have both the technical ability and appropriate quality systems to provide clinical trial grade genotyping.
Deciphering the complete human genome sequence has been one of man's greatest scientific achievements and will create a data set of the full complement of human genes. Variation within these genes is responsible for all of our individuality, including our likelihood of developing a disease and also response to therapy. It is hardly surprising then that the pharmaceutical industry is looking at ways to use this knowledge, not only to discover new drugs, but also to improve the way that these drugs are developed and used.
At present the majority of genetic analysis performed on behalf of pharmaceutical companies is to assist in the identification and validation of new targets for drug discovery. This is now changing and genetic testing is becoming increasingly common as part of the clinical trial process as scientists and clinicians begin to understand the benefits it can bring.
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