The design of clinical trials is at the center of new drug development: trials must be designed in an optimal manner if they are to yield quality answers to the research questions of interest. However, the biopharmaceutical industry’s organizational approach to drug development does not tend to utilize design best practices and apply them to either the design of individual trials or clinical development programs. The reasons for this inherent paradox — lack of good design in organizations that have the purpose of facilitating optimally designed clinical trials — are twofold. Firstly, R&D organizations tend to be centered around crossfunctional project teams, typically formed on the basis of technical or therapeutic expertise, not on well-practiced design skills and processes. Secondly, these teams are typically not incentivized to foster open approaches to design or to use structured design methodologies that lead to high quality and performance.
Article September 27, 2013