Number and Quality of Sites are Crucial to Phase I Clinical Trials

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Although numerous sites can be beneficial in Phase I clinical trials, new data show that trials with fewer sites encounter fewer enrolling complications, according to a new study from Cutting Edge Information.

“Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials”

Cutting Edge Information’s study, “Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials,” found that trials using four to five sites need double the amount of time to enroll patients compared to trials using two to three sites. The time savings on patient enrollment are critical considering clinical trial managers’ numerous and time-consuming responsibilities, such as coordinating investigator meetings, developing clinical protocol and organizing trial sites.

“Organizing multiple sites is a big task and it increases the time required for those sites 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.”

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

“Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials” (http://www.cuttingedgeinfo.com/research/clinical-development/clinical-pharmacology/) examines and defines the critical cost drivers when budgeting for Phase I clinical trials. Research also benchmarks planning considerations including clinical team structure by analyzing data collected from 30 Phase I clinical trials. Use this report to:

Save time and prevent costly delays with early strategic planning of Phase I 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 I trials.
Explore data sets for 12 oncology Phase I clinical trials.

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