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Variability in Protocol Design Complexity by Phase and Therapeutic Area

Title
Variability in Protocol Design Complexity by Phase and Therapeutic Area

Abstract
The Tufts Center for the Study of Drug Development analyzed 8,317 clinical trial protocols to benchmark protocol complexity by phase and therapeutic area and to characterize trends in clinical trial complexity and the burden placed on study staff to execute protocol procedures between 2000 and 2007. Wide variability in protocol complexity and work burden was observed across therapeutic areas, within and between clinical research phases. Phase 1 protocols are the most complex and the most demanding to execute. The mean number of total procedures per protocol in phase 4 studies and the work burden associated with phase 1 protocols grew the fastest between the periods 2000–2003 and 2004–2007. The complexity and work burden of phase 3 protocols also grew rapidly during this period. Protocols in anti-infectives, immunomodulation, CNS, and oncology are consistently the most complex and burdensome to execute. Reasons for the wide variability in protocol complexity and work burden by phase and therapeutic area are discussed. This study provides insight into areas where protocol design improvements should be targeted.