Combining drug-disease and economic modelling to inform drug development decisions.

Drug-disease models and clinical trial simulations are increasingly being used to support trial design and treatment optimization decisions. Less widely recognized is their potential for guiding strategic development decisions. These decisions require economic valuation of the potential product profile of efficacy, safety, ease of use, and so on. This review presents a disguised case study that uses drug-disease modelling to generate a probabilistic forecast of a drug's profile. This allows a quantitative analysis of whether to pursue a once-a-day regimen for an antiretroviral being tested twice-a-day in Phase II trials, and if so, at what dose and for which market segments.