Examination of Clinical Trial Costs and Barriers for Drug Development. E.4 Analysis of Barriers to Clinical Trials


In selecting barriers to analyze in the context of the clinical trial decision-making model developed, we considered whether each proposed strategy could be alleviated by policies, whether the appropriate policies could be implemented or encouraged by FDA, and whether there was evidence in the literature that could be used to quantify the potential impacts of those policies on clinical trial costs. Based on these criteria, the following barrier mitigation strategies were selected for analysis in this study:
  • Use of electronic health records (EHR)
  • Looser trial enrollment restrictions
  • Simplified clinical trial protocols and reduced amendments
  • Reduced source data verification (SDV)
  • Wider use of mobile technologies, including electronic data capture (EDC)
  • Use of lower-cost facilities or at-home testing
  • Priority Review vouchers
  • Improvements in FDA review process efficiency and more frequent and timely interactions with FDA

Our analysis suggests that priority review vouchers and improvements in FDA review efficiency can help to shorten timelines, which in turn increase the expected net present value (eNPV) to the drug sponsor. Because these options affect the final stage of clinical research (mainly NDA/BLA approval), heir overall dollar value for a sponsor at the start of clinical research is much lower due to discounting. Therefore, holding everything constant, these options may be less appealing as strategies to stimulate drug development than alternatives which substantially lower costs early on in the clinical research process. Use of lower-cost facilities/in-home testing and wider use of mobile technologies appear to be most effective in reducing costs across therapeutic areas and trial phases. Use of lower-cost facilities and/or inhome testing can reduce per-trial costs by up to $0.8 million (up to 16 percent of cost per study) in Phase 1, $4.3 million (up to 22 percent of cost per study) in Phase 2, and $9.1 million (up to 17 percent of cost per study) in Phase 3, depending on therapeutic area. Wider use of mobile technologies can result in very similar maximum savings; $0.4 million (up to eight percent of cost per study) in Phase 1, $2.4 million (up to 12 percent of cost per study) in Phase 2, $6.1 million (up to 12 percent of cost per study) in Phase 3, and $6.7 million (up to 13 percent of cost per study) in Phase 4. On the other hand, loosening trial enrollment restrictions and reducing SDV efforts have smaller impacts on costs, resulting in maximum savings of less than $0.1 million to $0.2 million per trial, representing approximately one percent of perstudy costs in Phases 2 and 3.


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