The Pulse on Study Startup

Despite years of valiant efforts, study execution remains far from optimal

December 11, 2017

The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal. For study startup, the data are dismal: Contract cycle times have doubled from an industry median of 1.5 months in 2009–2011 to more than three months in 2014–2015.

Nearly 50% of clinical trials are behind schedule, with slow patient enrollment cited as the top reason. Research also suggests a lengthy 16.7 months is typically required to initiate all approved sites for phase II–III trials.