|[January 03, 2013]
Planning at Beginning of Phase I Trials Saves Time and Prevents Unnecessary Delays
RESEARCH TRIANGLE PARK, N.C. --(Business Wire)--
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
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
For more information about Phase I clinical trials and their critical
cost-drivers, contact Cassie Demeter at 919-403-6583.
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