SOURCE: Cutting Edge Information

Cutting Edge Information

June 22, 2011 09:23 ET

Patient Recruitment and Clinical Vendor Fees Top Trial Cost Drivers

RESEARCH TRIANGLE PARK, NC--(Marketwire - Jun 22, 2011) - The highest clinical trial cost drivers are patient recruitment costs and vendor fees, according to a new study on clinical operations from Cutting Edge Information.

At 32% of trial budgets, the largest single driver of clinical costs -- patient recruitment -- has been a challenge for clinical development teams for years. Although patient recruitment represents almost one-third of clinical costs, few companies actually prepare for recruitment expenses or implement best practices to accelerate the patient recruitment process.

Patient recruitment isn't the only driver of rising clinical costs. Vendor fees and site recruitment are having a larger impact on clinical expenditures today than in the past. The biggest single reason for issues in these areas, say interviewed executives, is ever-increasing competition for top investigators. An increase in the number of trials across the board means that more and more companies want to attract the best-performing CROs and sites, which drives higher prices. Likewise, finding CROs and sites that are not recruiting against themselves by running similar studies is proving challenging -- and thereby expensive.

Cutting Edge Information's study, "Clinical Operations: Benchmarking Per-Patient Trial Costs, Staffing and Adaptive Design," available at http://www.cuttingedgeinfo.com/research/clinical-development/trial-operations/, surveyed 59 pharmaceutical, biotech and clinical service organizations.

On average, the findings found that the largest clinical cost drivers are:
* Patient recruitment: 32%
* Vendor fees: 25%
* Site recruitment: 14%
* CTMS and other technology: 12%:
* Site retention: 8%:
* Data management and validation: 7%
* Patient retention: 2%

"The impending patent cliff is putting an incredible strain on drug manufacturers to develop new treatments," said Jason Richardson, president at Cutting Edge Information. "You can imagine the challenge that R&D teams have guiding these pipeline products from discovery to market in an age when clinical trial costs are at an all-time high."

Cutting Edge Information developed "Clinical Operations: Benchmarking Per-Patient Trial Costs, Staffing and Adaptive Design" to provide best practices and strategies that help clinical development teams to improve trial efficiency, cut costs and earn products more time on the market to recoup expenses.

The new study provides up-to-date benchmarks to help development teams increase clinical trial efficiency. Clinical trial costs and staffing metrics are presented across several therapeutic areas in all phases of development.

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