Examination of Clinical Trial Costs and Barriers for Drug Development. 4.6 Drug Sponsor-imposed Barriers


Drug sponsors face a number of barriers to conducting clinical research that are outside their control. However, there are also a number of barriers that drug sponsors voluntarily impose upon themselves, adding further cost and delay to the process unnecessarily. While some of these avoidable costs and delays are incurred as a result of insufficient early planning or inefficiencies in company practices, the majority of them stem from a desire to avoid failure at all costs (Kramer & Schulman, 2011).

Risk aversion leads companies to take unnecessary steps at various points throughout the clinical trial process. As one drug company representative explained, there is a “bad feedback loop”; clinical trials are so costly that companies will spend millions more to achieve small reductions in the risk of failure. Legal advisors are major drivers of these strategies, which are designed to ensure regulatory compliance and minimize liability (Kramer, Smith, & Califf, 2012). In trial design, each assumption is made conservatively, and the study ends up being overpowered. At larger companies especially, statisticians and others are insulated from the cost consequences of their recommendations, so there is less accountability; no one objects because no one wants to be responsible for failure.

The rest of this section discusses, in greater detail, the various barriers that drug sponsors impose upon themselves in their administrative, study design, data and site monitoring, and serious adverse event reporting practices.

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