Molecular methods for profiling tumors, when incorporated into the clinical development process and linked to clinical outcome of patients, have the potential to improve efficacy of clinical trials in oncology, thereby enhancing the chance that drugs will succeed through clinical phase III and registration.

There is wide recognition that such pharmacogenomic strategies will significantly reduce development costs. Pharmacogenomics applied to drug development in oncology will enable:

• Prediction of therapy outcome for individual cancer patients and selection of the optimal drug.
• Selection of patients for clinical trials on an informed basis.
• Categorization of patients in responders and non-responders with respect to given drugs.
• Reduction in clinical trial costs (phase III and phase IV).
• Enhanced chance of registration of novel cancer drugs.
• Avoidance of unnecessary and inappropriate treatments.