Patient Recruitment Is Largest Roadblock in Clinical Trials, Says Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - April 14, 2009) - Finding patients for clinical trials is the toughest part of the long, expensive path to new drug development.

According to "Streamlining Clinical Trials," a study by Cutting Edge Information, patient recruitment is the largest factor in increasing clinical trial costs. Its share of total clinical development time has increased to 23% of the timeline. More alarming, two thirds of companies indicate that this percentage continues to increase despite efforts to reduce patient recruitment delays.

Drug developers wrestle with ways to streamline the clinical trials process. According to the Tufts Center for the Study of Drug Development, clinical trials now comprise 60% of total development costs, up from 30% in the 1980s. Emerging means for screening potential patients, such as genetic tests, mean that companies must plan for higher lab-testing costs and a lower rate of prospective patient enrollment. And the Canadian Medical Association Journal (CMAJ) in February published an article claiming that drug development costs had increased at a rate 7.4% higher than inflation.

According to CMAJ, pharmaceutical companies are increasing their outsourcing, especially to countries with fewer regulatory delays in the trial approval process. Electronic data capture systems and the use of surrogate endpoints in Phase II trials are also being explored by some companies as a means for accelerating studies.

The data in "Streamlining Clinical Trials," however, show that patient recruitment remains the largest roadblock to faster, cheaper studies.

"In the past, patient recruitment improvement has focused on making sponsors and trials more accessible and convenient for patients," says David Richardson, leader writer for the report. "More recently, companies have been deploying web-based recruitment, including informational trial websites."

These improvements have helped, says Richardson, but they do not address new challenges in patient recruitment.

"Increasingly, problems stem from increased competition for patients and regulatory policies than from poor marketing or site selection."

The report 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. CEI also draws comparisons to its 2006 and 2004 studies to show clinical development trends.

A complimentary brochure for the report is available for download at http://cuttingedgeinfo.com/clinicaltrialbenchmarking/index.htm#body

Contact Information: CONTACT INFORMATION: David Richardson 919-433-0216