SOURCE: Cutting Edge Information

Cutting Edge Information

July 06, 2011 10:01 ET

Clinical Trial Staffing Levels Skyrocket

New Study Finds That Outsourcing and Greater Expansion Into Emerging Markets Drives Drug Development Staffing

RESEARCH TRIANGLE PARK, NC--(Marketwire - Jul 6, 2011) - Average clinical trial operations department sizes have more than doubled since 2008, according to a new report by Cutting Edge Information. The growth trend is across all phases of development and appears likely to continue as companies aim to get better results from a greater number of clinical trials.

The report, "Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design," tracks trial costs and staffing benchmarks for 100 trials across five key therapeutic areas and 12 positions. Cutting Edge Information compared new data with 2008 research and found that Phase I staffing increased by 150%, Phase II staffing tripled and Phase III staffing grew more than fourfold. Phase IV (post-marketing studies) staffing also increased, but by a more modest 85% over the last three years.

"With the number of trials proliferating, protocols becoming more complex and development teams competing for patients and investigators, clinical trial costs are at all-time high," said Jason Richardson, president of Cutting Edge Information. "To achieve their desired endpoints, trial sponsors must ensure that sites are adequately supported with the right personnel in place."

Much of the staffing increase is due to companies deploying a greater number of clinical research associates (CRAs) to monitor clinical trial sites. The need for increased monitoring has risen as more companies expand clinical development in emerging markets. Outsourcing drug development to clinical services and research organizations (CROs) has also increased total headcount counting both CRO personnel and sponsor personnel managing the relationship.

The number of clinical research associates, already the single largest group of clinical trial personnel, has grown to better meet changing trial demands. In 2008, for example, the average Phase II clinical trial employed 3.6 CRAs. Phase II trials now employ 9.0 CRAs, on average.

"Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design," ( contains staffing benchmarks and per-patient cost metrics across trials in all development stages. The study provides 26 key metrics of clinical trial performance as well as usage data and industry insights for adaptive clinical trials. The report provides benchmarking insights for better coordinating in-house staff and vendor teams to hit cost targets, deadlines and trial endpoints.

For more information about clinical trial cost and performance management, contact Elio Evangelista at +1 919-403-6583.

Contact Information

    Elio Evangelista