SOURCE: Cutting Edge Information

September 09, 2008 08:17 ET

According to Cutting Edge Information, Pharmaceutical Industry Expands Use of Clinical Trial Performance Measurements

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.

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