Abstract
Clinical trials of marketed drugs are useful to demonstrate a comparative advantage in the marketplace. The conduct of such studies is usually the responsibility of the medical division of the pharmaceutical company, and medical personnel must interact with product management in all phases of planning, feasibility analysis, assessment of time and money resource requirements, design of studies, and publication of study results. This paper reviews the process and includes guidelines for the internal review of promotional material to assure compliance with labeling and advertising regulations as they apply to comparative drug claims.
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