Trials and tribulations. Emerging issues in designing economic evaluations alongside clinical trials.

Decisions relating to designing and implementing economic evaluations alongside clinical trials are dependent on a number of issues initial consideration should focus on whether an economic evaluation is appropriate, whether a randomized controlled trial (RCT) is a suitable vehicle, and whether the design of the specific RCT is appropriate for integration of economic evaluation. If an economic evaluation is appropriate, decisions are required on how economic data are to be collected and analyzed. This paper discusses these and other issues and, where appropriate, provides recommendations for future studies.