Two-thirds of pharmaceutical and biotechnology clinical affairs organizations measure data error rates and proactively manage performance based on them, according to a new study, “Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity” (http://www.AcceleratedClinicalTrials.com), published by pharmaceutical industry research and consulting firm Cutting Edge Information.

Data errors extend clinical trial timelines and are counterproductive. Flawed and incomplete data submitted on case report forms delays new products from reaching the market, which hurts companies’ bottom-line sales. According to the report, “Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity” (http://www.AcceleratedClinicalTrials.com), companies lose between $600,000 for niche drugs and $8 million for blockbuster products each day clinical trial delays postpone drug launches.

According to the Tufts Center for the Study of Drug Development, delays resulting from clinical data errors cut drug companies’ bottom lines by as much as $2 billion per year (as measured in lost sales). This estimate does not even account for the approximately $125 cost of correcting each data error made on paper-based case report forms, according to e-trials.

“Data errors have become a costly and detrimental part of the clinical testing business,” said Eric Bolesh, senior analyst for Cutting Edge Information’s clinical affairs practice. “That two-thirds of companies include data error rates on their performance measurement scorecards shows the increased attention paid to identifying and correcting these mistakes.”

Cutting Edge Information’s newest industry report, “Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity” (http://www.AcceleratedClinicalTrials.com), includes benchmarks, practices, strategies and tactics for speeding up clinical trials gleaned from interviews with executives at many of the world’s top drug-makers, including AstraZeneca, Wyeth, Novartis, Bristol-Myers Squibb, and Janssen.  The report also reveals the following data to help clinical affairs planners refine strategy and streamline operations:

• 2004 clinical affairs budgets

• Investigator meeting budgets
• Per-patient clinical costs by phase and therapeutic area
• Clinical trial performance measures
• Clinical outsourcing spending patterns

To download a free summary of this 153-page report, please visit http://www.AcceleratedClinicalTrials.com.  For more information on this report, contact Diana Borja at diana_borja@cuttingedgeinfo.com or 919-433-0219. 

Clinical affairs practice leader, Eric Bolesh is a senior analyst with Cutting Edge Information.  Mr. Hess’s expertise includes clinical trials operations, early-stage drug development and commercialization, manufacturing quality control, and the generic drug market. For more information about our research and consulting services, contact Jon at eric_bolesh@cuttingedgeinfo.com or 919-433-0211.

 
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