Establishing value through pharmacoeconomics: the emerging third objective in clinical trials.

Establishing the value of a new medicine by applying the tools and methods of pharmacoeconomics has become an important third objective in many clinical trials. The pharmacoeconomic investigator conducting research in clinical trials must understand and conform to the rules and procedures governing the clinical trial process. This article addresses some of the vital yet often overlooked details associated with conducting pharmacoeconomic research in clinical trials. The protocol, the informed consent form, the data collection instruments, the study initiation, and the final study report are all discussed. Additionally, limitations of the study results are reviewed.