Economic analysis during phase III clinical trials: who, what, when, where, and why?

With the recent surge in interest in health care reform and the growth of managed care organizations, the cost of care has become a major determinant of the types and intensity of therapy that patients receive. if data on the cost effectiveness of new treatments are not collected during phase III trials, diffusion of new technologies may be restricted by managed care companies and insurers. We can collect the data needed to evaluate the costs and cost effectiveness of new therapies, as well as quality of life data, in phase III trials. But to collect these data effectively, many methodologic questions must be answered. For example, who needs to be involved in an economic analysis of a medical treatment; what data should be collected, when, and from whom; what data collection sources should be used; and how should the data be collected and validated? To embark on economic studies of new therapies, it is imperative that these issues be addressed early, during the design phase of a trial, and a course of action determined.