Economic analysis in randomized clinical trials

During the past 10 years, there has been a growing trend to incorporate economic evaluations within these randomized controlled trials of new pharmaceuticals (in phases II through IV), and to a lesser extent within trials of other medical therapies. The information developed from these evaluations is intended to inform decision makers about the value for the cost of these new drugs and technologies. This information will shed the most light on the question of value for the cost if the trial and the evaluation are appropriately designed, if appropriate data are collected and are appropriately analyzed, and if the many sources of uncertainty surrounding these evaluations are adequately addressed. This thesis addresses a wide range of issues related to economic evaluation conducted as part of randomized controlled trials, including: the description of a number of steps that are good practice for the collection, analysis, and reporting of economic data from these trials; exploration of methods for dealing with a number of sources of uncertainty that need to be addressed for sound interpretation of the data; and the provision of examples of data that can be provided by these trials other than the comparison of therapies to which the patients were randomized. It is intended to provide readers with an in-depth understanding of economic assessment conducted as part of randomized controlled trials