Using multiple sites for Phase I clinical trials may just complicate patient enrolment, a new US study suggests.
While there are benefits to spreading a Phase I trial across several sites, notes Cutting Edge Information, its research found that studies taking in four to five sites needed double the time to enrol patients than those using two to three sites.
Time savings on patient enrolment are critical given the numerous responsibilities weighing on clinical-trial managers, such as co-ordinating investigator meetings, developing clinical protocols and organising trial sites, Cutting Edge Information points out.
“Organising multiple sites is a big task and it increases the time required for those sites to become active,” commented Ryan McGuire, research team leader at Cutting Edge Information.
“Keeping site vendors to a minimum will help control costs, prevent delays and in some cases prevent site drop-off rates,” he added.
Data from the new study, Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials, also show that no Phase I study with three or fewer sites recorded any drop-offs due to inability to enrol patients.
The highest drop-off rate reported was in an oncology trial, where 71% of the seven sites involved were unable to enrol patients after initiation.