Number of Patient Visits Drives Phase I Trial Costs, New Study Finds

RESEARCH TRIANGLE PARK, N.C. -- (BUSINESS WIRE) -- A new study from Cutting Edge Information discovered that on average, oncology trials reported a total cost of nearly $2 million more than the average total cost of the other trials.

Cutting Edge Information’s study, “Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials,” found that increased cost and the number of required office visits are due to the increased complexity of Phase I trial procedures and tests. Of the reported trials, oncology and central nervous system/neurology tend to be the most involved clinical trial areas in terms of procedures. They also report the highest number of patient visits and average cost per patient.

The high frequency of visits and expensive medical procedures drive these costs up. One executive described an oncology trial that required daily visits over three weeks to determine the drug’s pharmacodynamics profile. In addition, oncology costs per patient cover a wide range due to the variability of procedures such as costly MRIs or biopsies.

“Of the trials examined in our study, 9 of the 10 longest trials are in oncology,” said Ryan McGuire, research team leader at Cutting Edge Information. “Overall, the number of patient visits is a strong indicator of the complexity, duration and trial cost and should be considered when budgeting for the Phase I study.”

“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, plus other therapeutic areas.

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