White Paper

Benefits And Challenges Of EDC Adoption In Clinical Trials

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By Olivier Roth Marketing Manager, ClinCapture

What are the main benefits of EDC implementation? How does it contribute to the cost-efficiency of clinical trials? What are the challenges and limitations that sponsor companies can expect when implementing EDC solutions?

Clinical research is one of the most expensive areas of drug development. Bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.3 billion, or an average of $146 million per year.

Industry data shows that clinical trials costs are growing across all development phases. A 2011 report, Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design by Cutting Edge Information, tracked costs for 100 trials across multiple therapeutic areas finding that per-patient clinical trial costs rose an average 70% from 2008 to 2011. The largest increases occurred in Phase IIIa and Phase IIIb. Phase I trials are also suffering from cost inflation, with per-patient costs increasing by an average 46% over the same time period.

Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing. This white paper will review the main benefits of EDC implementation, and how it contributes to cost-efficiency. It will also discuss challenges and limitations that sponsor companies can expect when implementing EDC solutions in clinical research and share best practices suggested by clinical trial experts.