Examination of Clinical Trial Costs and Barriers for Drug Development. 4.5 Regulatory and Administrative Barriers


Regulations are often created in response to a negative event befalling a trial participant or a study as a whole (Kramer, Smith, & Califf, 2012). While these regulations are intended to improve safety or other facets of the clinical research process, many times they are not subsequently evaluated to determine whether they actually achieve those purposes or are simply creating additional obstacles.

Furthermore, U.S. regulations pertaining to clinical research were written when the clinical trials enterprise was smaller in terms of the number of active trials and before multicenter trials became common (in the 1980s-1990s) (Kramer, Smith, & Califf, 2012). This section addresses several subcategories of regulatory and administrative barriers.

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