Cost/Effectiveness Considerations in Clinical Trials

Clinical trials raise a variety of benefit-cost and cost-effectiveness considerations. To date, these considerations have received minimal attention from persons performing trials. Analysis of the benefit-cost aspects of a trial should shed additional light on, or add a new dimension to, the applicability of the results to clinical practice. End points such as quality of survival, not just survival itself, may need to be examined. While a demonstration of cost-effectiveness should not necessarily be the ultimate objective of a clinical trial, if attention is paid to the potential cost-effectiveness implications of a trial under design, the design itself might be improved