This paper covers Eli Lilly and Company's experiences and lessons learned while integrating a very large global pharmacoeconomic and quality of life study within a Phase III clinical trial. The information contained in this report will assist in outlining the required work and providing a framework for completing the project efficiently. Five steps are covered: background research, development of the pharmacoeconomic plan, development of the quality of life plan, obtaining local input into the proposal, and dissemination of results.
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