Case Study: Recruitment Expertise Reduces High Screen Failure Rate

The study was part of the customer's extensive clinical trials program. The primary objective of the study was to investigate whether long-term statin therapy compared with placebo will decrease the rate of major CV events in individuals with low LDL cholesterol who are at high vascular risk on the basis of an enhanced inflammatory response determined by elevated levels of CRP.

The secondary objective was to investigate the safety of long-term treatment with the study drug compared with placebo through comparisons of total mortality, non-cardiovascular mortality and adverse events. Additionally, the study investigated whether therapy with the study drug reduces the incidence of Diabetes Mellitus, Venous Thrombo-embolic events and incidences of bone fractures.

Key Challenges
This study faced a number of challenges, including an anticipated screen failure rate of 80%. Despite those expectations, recruitment targets outpaced timelines by 150%. This resulted in the unexpected challenge of a monitoring backlog. Rapid recruitment results notwithstanding, quality issues were reported at some inexperienced and fast-recruiting sites. Additionally, difficulty with IMPACT, the sophisticated electronic reporting system, created challenges for monitors.

How Were These Challenges Met?
Specialized Capabilities

The Quintiles team developed a profile of patients who would be more likely to fulfill criteria and distributed it to sites. Additional resources were added to assist with specialized tasks such as consent review, monitoring screen failures, and drug accountability.