SOURCE: Cutting Edge Information

November 19, 2008 07:47 ET

Cutting Edge Information Releases Study Showing Drug Companies Tap High-Population Developing Nations for Clinical Trial Subjects

RESEARCH TRIANGLE PARK, NC--(Marketwire - November 19, 2008) - Clinical trial patient recruitment and retention has the greatest impact on clinical trial costs, according to "Streamlining Clinical Trials" (www.clinicaltrialbenchmarking.com), a new study by pharmaceutical business intelligence leader Cutting Edge Information. Not only does patient recruitment and retention affect direct trial costs, but they also can have a huge bottom-line impact when they delay drug trials and, ultimately, new product launches. As a result, drug companies are increasingly relying on high-population developing nations as a source of new study patients.

Largely untapped patient populations, along with the lower cost of running clinical studies in many emerging countries, also has caused a surge in the number of clinical research organizations (CROs) that are establishing trial centers in countries such as China, India and Brazil. In a keynote speech at the China Trials 2008 Global Clinical Development Summit in Shanghai, Perry Nisen, M.D., Ph.D., Senior Vice President, Cancer Research at GlaxoSmithKline, emphasized China's importance to his company reaching goals in clinical trials. Nisen noted the influx of demand for trials in China as being a direct cause for China's improved trial practices and burgeoning drug development talent pool.

"As patient recruitment and retention remains one of pharma's greatest drug development challenges, conducting clinical trials in high-population developing countries is conducive to hitting aggressive development timelines," says David Richardson, research team leader at Cutting Edge Information.

"Streamlining Clinical Trials" (www.clinicaltrialbenchmarking.com) addresses numerous trial operations issues, including 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.  An entire chapter of the report is devoted
    to the latest trends and tools in recruitment.
    
--  Budgeting and Performance Assessments: Clinical project managers must
    set clear performance expectations.  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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