Contact Information: CONTACT INFORMATION: David Richardson 919-433-0216
According to Cutting Edge Information, Pharmaceutical Industry Expands Use of Clinical Trial Performance Measurements
| Source: Cutting Edge Information
RESEARCH TRIANGLE PARK, NC--(Marketwire - September 9, 2008) - Clinical trial performance
measurements, initiated at top pharmaceutical companies a few years ago,
are now catching on among mid-size and even smaller pharmaceutical
companies, according to "Streamlining Clinical Trials," a new study by
pharmaceutical business intelligence leader Cutting Edge Information.
Because such measures serve as indicators of the biggest challenges to
clinical trials, companies of all sizes have begun to incorporate them into
their clinical trial procedures.
At the top of the list, 'Time to enroll a target number of patients' and
'Time from last patient out to database lock' were each measured by 68% of
companies. Patient enrollment remains an intense focus for the
pharmaceutical industry and is considered one of the most significant
delays in the clinical trials process. In fact, 43% of companies reported
that a longer than desired time to complete patient enrollment could shift
the entire organization of the clinical trials department.
"As FDA regulations become more stringent, patient populations that satisfy
clinical trial criteria become much more difficult to recruit," says David
Richardson, research team leader at Cutting Edge Information. "Some
companies are being forced to move trials overseas in order to get adequate
participation from their target populations."
"Streamlining Clinical Trials" (www.clinicaltrialbenchmarking.com) covers
resource allocation, performance measurement, continuous process
improvement, patient and investigator recruitment and adaptive trial
designs. Data include clinical development budgets, clinical operations
team structures and staffing levels, performance measurement and
management, clinical operations hurdles and process improvement tools and
tactics. The report focuses on three aspects:
Patient Recruitment: Patient recruitment continues to dominate clinical
timelines and budgets. The report devotes an entire chapter to this
challenge, providing the latest trends and tools in recruitment.
Budgeting and Performance Assessments: Clinical project managers must set
clear performance expectations and measure and manage trials. The report
provides clinical spending benchmarks to assist in trial budgeting and
planning.
Clinical Operations Structure and Work Flow: Clinical trial management team
members must know their roles and responsibilities, and communication with
vendors and investigators must be seamless. The report outlines major
obstacles clinical teams face and presents real-company, proven solutions.