Protocol amendments improve elements of clinical trial feasibility, but at what cost? Tufts CSDD

Research sponsors implement at least one substantial global amendment for nearly 60% of all clinical trial protocols, substantially reducing the number of actual patients screened and enrolled, but leading to significantly longer clinical trial durations and higher costs, a newly-completed analysis by the Tufts Center for the Study of Drug Development concludes.

The total median direct cost to implement a substantial amendment for Phase II and Phase III protocols is $141,000 and $535,000, respectively, according to the Tufts CSDD analysis, which defined a substantial amendment as any change to a protocol on a global level requiring internal approval, followed by approval from the institutional or ethical review board or regulatory authority.

In addition, nearly half of all substantial amendments - most often undertaken to modify study volunteer demographics, eligibility criteria, and safety assessment activity - are deemed avoidable by sponsor organizations, Tufts CSDD said.