Regulatory imperatives and competitive forces have led pharmaceutical companies to focus on extending the scope of their randomized controlled trials (RCTs) to collect data to address economic as well as safety and efficacy questions. To guide researchers, a significant literature exists on various methodological aspects of conducting economic evaluations within an RCT framework. Little has been published, however, about data handling issues surrounding the management of the economic data collection effort. Thus, the objective of this paper is to present an overview of a project conducted in order to tackle various aspects of the economic data management process with a view to improving the efficiency of study conduct. The project outputs include case report forms (CRF), guidelines for CRF completion, and templates for producing statistical analysis plans and study protocols. Directions for further research are highlighted.
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