The current biopharma drug development paradigm, including an organizational structure centered around project teams, is not well-constituted to embody design best practices even though design of clinical trials is at the heart of the drug development endeavor. Teams tend to be formed on the basis of technical or therapeutic expertise, not on the basis of well-honed design skills. Furthermore, teams tend not to be incentivized to foster open approaches to design or to use structured design methodologies that lead to high quality and performance.

As a result, there is great variability in the quality of the programs and trial designs produced by project teams. This results in less efficient clinical trial execution or failed outcomes. A more systematic approach to design — grounded in best practices from other industries — could result in improved success rates and more cost-effective, timely clinical trial execution. To achieve these results, biopharma first must recognize that design can be conducted as a structured process, and that design tools can be developed to facilitate such a process and ultimately, drive better outcomes.