Quantity and Quality of Sites is Crucial to Phase 1 Clinical Trials

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Although numerous sites can be beneficial in clinical trials, especially where quantity of patients are required instead of healthy volunteers, a new Cutting Edge Information study’s data show that Phase I trials with fewer sites encounter fewer enrollment complications.

“Keeping site vendors to a minimum will help control costs, prevent delays and in some cases prevent site drop off rates.”

Cutting Edge Information’s recent study, “Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase 1 Trials,” found that the number of months that sites actively engage in patient recruitment doubles when companies reported using four to five sites versus two to three sites. The increased duration is understandable when accounting for the difficult and time-consuming activities associated with coordinating investigator meetings, planning clinical protocols and organizing clinical trial sites.

“The daunting task of organizing multiple sites increases the time required for them to become active,” said 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.”

The study’s data show that no trial with three or fewer sites recorded any drop offs due to an inability to enroll patients. The highest drop-off rate reported was an oncology clinical trial where 71% of the seven sites were unable to enroll patients after initiation. Trial managers should be looking for the best quality sites because sites lacking standard operating procedures (SOPs) or those that are non-compliant with good clinical practice (GCP) can lead to more trouble than necessary.

“Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase 1 Trials” (http://www.cuttingedgeinfo.com/research/clinical-development/clinical-pharmacology/) examines and defines the critical cost drivers when budgeting for Phase 1 clinical trials. The benchmarks within cover planning considerations, including clinical team structure, as well as analysis of data collected from 30 Phase 1 clinical trials. Use this report to:

• Save time and prevent costly delays with early strategic planning of Phase 1 trials.
• Balance the number and quality of trial sites during site selection to manage patient enrollment and drop-off rates.
• Manage critical cost-drivers, including the number of patients and required patient visits, when budgeting for Phase 1 trials.
• Explore data sets for 12 oncology Phase 1 clinical trials.

For more information about Phase 1 clinical trials and their critical cost-drivers, contact Cassie Demeter at 919-403-6583.