Virtual trials could improve drug development
New techniques for creating virtual early-stage clinical trials using advanced modelling techniques will improve the process of drug development, according to Dr Amin Rostami, from the University of Sheffield and Director of Research & Development at Simcyp.
Speaking at the British Pharmacological Society conference in Brighton, Dr Rostami described the importance of new pharmacokinetic modelling techniques and how these can help drug development researchers to select the best candidates for human investigations, avoiding inconclusive outcomes caused by poor study design.
Dr Rostami commented on several recent clinical studies which had failed to properly assess the impact of genetic differences in the expression of the metabolic enzyme CYP2C9 on patients' responses to warfarin - the most widely prescribed anticoagulant in North America and most European countries. Referring to the recent findings of his research team, he said, "If modelling and simulation using the Simcyp platform had been employed before these studies began, the researchers could have optimally designed their investigations, avoiding costly inconclusive outcomes using human volunteers."
The issue is becoming increasingly more relevant in drug development, with the Food and Drug Administration (FDA) in the USA recently extending product labelling of warfarin to include information on how genetic makeup affects patients' responses to the drug.
"The Simcyp Simulator platform is an extremely powerful tool in the development of new drugs, allowing researchers to take full advantage of available data when designing the next set of experiments. This enables better and more accurate decisions to be taken, both on the viability of expensive investigations and on the precise patient makeup for inclusion in human studies," added Dr Rostami. "Modelling and simulation is crucial when designing studies which impact on rare genotypes or in identifying individuals at extreme risk from adverse reaction."
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