Economic evaluation alongside multinational clinical trials - Study considerations for GUSTO IIb

Data relevant to economic evaluation are being collected alongside clinical trials with increasing frequency. When these trials involve health outcomes and resource utilization in many different countries, numerous methodologic problems arise. This paper describes and discusses the methodology for economic evaluation that will be used in the Economic Substudy of GUSTO IIb, as an example of how to address the problems that arise in economic evaluations linked to international trials.