Role of decision analysis in relation to clinical trials and a US perspective of the Battelle model.

Economic assessment of evolving technologies is assuming increasing importance worldwide. One form of economic assessment uses decision analysis, a simulation technique, to determine whether performing a clinical trial is worthwhile. This type of assessment may streamline data collection within a clinical trial, and can aid in the interpretation of a trial result with substantial benefits and toxicities. Although second-line chemotherapy for patients with metastatic breast cancer is in common use, its benefit is unclear and it is associated with substantial cost. A database search of currently active or recently closed randomised phase III comparative trials for metastatic breast cancer found only 6 trials involving a comparison of chemotherapies. Only 1 trial allowed prior chemotherapy for metastatic disease. Given the paucity of forthcoming clinical data, decision analysis is an appropriate tool for estimating the effectiveness of potential treatments with second-line agents for metastatic breast cancer. The findings of the Battelle decision analysis model, described in this issue, identified response rates and 1-year mortality as the key areas of focus for comparative trials. Decision analysis can improve the design and efficacy of prospective, comparative trials but cannot replace them.