Abstract
A Federal perspective is provided to the questions posed of the summary panel. Additionally, comments to presentations are provided. In general, unless the clinical trial is modified to collect the data needed, information for cost-effectiveness studies cannot be gotten from clinical efficacy studies such as randomized clinical trials. The information from cost-effectiveness studies can be used by manufacturers to better understand the dynamics of a changing market. Specification of the perspective of the cost-effectiveness study is needed as well as consideration of changing market forces in the model. A number of issues related to use of the results of cost-effectiveness studies were presented for consideration along with a proposal to adjust outcomes by group characteristics.
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