Competition for sites and enrollment issues has led to an increase in the number of non-active, non-enrolling (NANE) sites being activated for clinical trials.
Nearly 60% of protocols require
one or more amendments, with 40%
of all amendments occurring before the
first study volunteer receives their first dose
in the clinical trial.
Increased protocol complexity — number of amendments, number of endpoints, eligibility criteria — has created challenges with site feasibility assessments.
Outsourcing of clinical trials has led to a reliance on global affiliates to understand all local processes and approvals, combined with ongoing study complexities, including volunteer to screen completion rate, has increased costs and delays.
20-50% of clinical trials will have
a “rescue mission” where new sites are
added in order to cure a shortfall in patient enrollments.