Critical path activities in clinical trial setup and conduct: How to avoid bottlenecks and accelerate clinical trials

Abstract

Most clinical trials are delayed due to scientific and/or operational challenges. Any effort to minimize delays can generate value for patients and sponsors. This article reviews critical path process steps commonly identified by practitioners, such as during protocol development, site contracting, or patient recruitment. Commonly considered measures, such as adding more trial sites or countries, were contrasted with less frequented measures, such as evidence-based feasibility or real-world evidence analysis, to help validate assumptions before clinical trial initiation. In a broad analysis, we integrated a literature review with a practitioner survey into a framework to help decision makers on the most critical process steps when setting up or conducting clinical trials in order to bring critical treatments to patients faster.

Keywords: R&D productivity; clinical trials; critical path; pharmaceutical industry; trial acceleration.