[January 03, 2013]

Planning at Beginning of Phase I Trials Saves Time and Prevents Unnecessary Delays

Phase I oncology clinical trials are particularly troubled by enrollment delays, more so than any other therapeutic area surveyed, according to a new report by business intelligence firm Cutting Edge Information.

The study, "Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials," found that the overall averages for planned and actual trial duration are 15.3 months and 20.6 months, respectively, representing an average of 5.3 months of delays. Oncology trials had planned durations of 23.8 months but the actual average was 36.1 months - over a year of delays on average.

Keeping Phase I trials on schedule can be extremely difficult, with unforeseen delays coming from patient recruitment challenges and difficulty managing multiple sites. Of the 40% of time spent on trial execution, half is for patient enrollment. The finaliation process takes up 26% of the Phase I time, split evenly between data cleaning, analysis, and review. Some therapeutic areas avoided lengthy delays by spending a large proportion (more than 40%) of their Phase I trials in the planning phase, ensuring that CROs and vendors were lined up and prepared before initiating the trials.

"When delays do occur, companies can implement amendments to the trial design that can broaden the criteria for enrollment and ease the recruitment process," said Ryan McGuire, lead research analyst at Cutting Edge Information.

"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.

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