Development and application of linked pharmacometric-pharmacoeconomic analyses in clinical drug development


Daniel Hill-McManus


Medical Research Council (MRC)
Network of Hubs for Trials Methodology Research (HTMR)

Project Summary

Model-based drug development uses pharmacometric (quantitative pharmacology) approaches to inform trial design and optimise compound development strategies. This approach aims to reduce late-stage failure and improve the efficiency of drug development. This PhD project aims to develop case studies for application in clinical drug development. The project aims to improve methods for strategic, clinical and pricing decisions during phase II/III drug development.

Population pharmacokinetic–pharmacodynamics (PPKPD) models and /or pharmacological model-based meta-analyses describe the time-course of drug action on relevant biomarkers or condition-specific outcome measures.

These can provide the inputs to standard pharmacoeconomic models which, by including the relevant health states, applying NHS costs, and discounting to net present value, can reveal an estimate of the price of the drug which would result in it being cost-effective. Using value of information analyses a trial would be considered worth undertaking if the expected value of sample information is greater than the cost of the trial. The accumulation of evidence supporting pharmacometric/economic modelling will increase confidence in its application.

This project is funded by the MRC under their Network of Hubs for Trials Methodology Research programme. This was established to create a UK-wide regionally distributed research resource to improve the design and conduct of clinical trials.