Craig Morgan NZCS, MBA (Hons), PMP, Head of Marketing at goBalto, Inc.
Over the past decade study startup, encompassing the activities associated with site identification, feasibility assessment, selection and activation, has become a priority improvement area in the conduct of clinical trials.
Numerous factors can adversely impact study startup and its efficiency, in an industry plagued by rising development costs and increasing complexities. Complex protocols (leading to increased difficulty in finding patients who meet the inclusion/exclusion criteria), protocol amendments, competition for sites, contract and budget negotiations, regulatory changes and compliance for global studies, IRB approvals, PI and CRA turnover, and others, contribute to significant trial delays.
It’s difficult to understand why there is so much variation and why there are so many inefficiencies and delays in study startup, this was the impetus behind this research. In a recently completed comprehensive study, The Start-up Time and Readiness Tracking (START) II, 2017 conducted by Tufts Center for the Study of Drug Development (CSDD) a significant difference in cycle times between new vs repeat sites and organizations (sponsors vs. contract research organizations (CROs)) was observed, however the percentage of sites never activated remained at 11%, a figure which has not changed substantially in over a decade. The primary reason cited was budgeting and contracting problems, which has been a challenge identified in much published work.