Economic evaluations during early (phase II) drug development - A role forclinical trial simulations?

Faced with increasing demands on demonstrating cost effectiveness, pharmace utical companies are required to conduct pharmacoeconomic evaluations throu ghout the drug development programme. At present, there is particular empha sis in the literature on burden-of-illness studies and on economic evaluati ons conducted alongside phase III clinical trials but not on those conducte d during phase II clinical trials. This article describes modelling techniques, namely clinical trial simulati ons (CTS), which are gaining popularity in the clinical research community, but which might also prove to be beneficial during the conduct of these ea rly pharmacoecononnic evaluations. The basic concepts and structure of CTS are described by using published examples of simulations of antipsychotic a nd anticancer drugs. With the use of an illustrative example of a hypotheti cal cholinesterase inhibitor for Alzheimer's disease, an integrated CTS-bas ed pharmacoeconomic evaluation is presented. The results demonstrate how th e modelling may be of value in 'go/no-go' decisions during the drug develop ment programme.