Examination of Clinical Trial Costs and Barriers for Drug Development. Executive Summary


Pharmaceutical companies conduct clinical trials for many reasons. The most obvious goal of clinical trials is to demonstrate safety and efficacy to gain Food and Drug Administration (FDA) approval. FDA provides guidance to developers about what constitutes acceptable clinical trials and appropriate outcomes. Improving the drug development process, especially by conducting better (meaning providing more information on safety or efficacy) and faster clinical trials, can foster innovation in medical product development. Therefore, by identifying costs, efficiencies, and hurdles throughout the clinical trial process, this report can provide guidance to the industry to assist their drug development process.
This study, conducted by Eastern Research Group, Inc. (ERG) under contract to the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Planning and Evaluation (ASPE), 1) examines the pharmaceutical companies’ decision-making process for the design and execution of clinical trials, and 2) identifies factors that may delay, hinder, or lead to unsuccessfully completed trials and 3) develops an operational model of clinical trial decision-making to enable examination of what-if scenarios by end-users.


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