SOURCE: Cutting Edge Information

Cutting Edge Information

July 27, 2011 12:05 ET

Phase IV Clinical Trial Teams Identify Top Challenges for Post-Marketing Studies

Patient Enrollment Stands Out as Opportunity for Improvement, Finds Cutting Edge Information

PHILADELPHIA, PA and RESEARCH TRIANGLE PARK, NC--(Marketwire - Jul 27, 2011) - Phase IV clinical trial managers face several challenges in maximizing the impact of post-marketing studies, but patient enrollment stands out as the largest bottleneck and best opportunity for trial acceleration, according to a newly released study from Cutting Edge Information.

The study, "Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," asked industry executives to rate clinical activities based on opportunity to accelerate the trial process. Patient enrollment ranked highest for opportunity to accelerate post-marketing studies. Other opportunities included site selection, enrollment and contracting, data cleaning and protocol development and writing.

Study data also show that patient enrollment is the most time-consuming Phase IV trial process, taking up to 30 percent of the timeline for all trial types. "Finding patients is a formidable task for any clinical trial, and Phase IV studies are a fast-growing area that may require specialized patient populations," said Adam Bianchi, chief operating officer of Cutting Edge Information.

"Companies must develop strategies to manage internal and external competition and expedite the trial process."

Increase Focus on Post-Marketing Research

Phase IV trials have become critical in light of an increasingly stringent regulatory environment, payer demands and crowded markets. As a result, allocating organizational and resource support for post-marketing studies is vital. However, companies sometimes under-prioritize Phase IV trials in favor of earlier-stage programs, contributing to Phase IV inefficiency, patient enrollment difficulty and trial delays.

"Phase IV studies enable companies to achieve key clinical and commercial objectives," Bianchi said. "But to reap full benefits, companies must provide adequate resources and attention to them."

"Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," available at, contains benchmarks to improve Phase IV study strategy and execution, focusing on structure, timelines, budgets, and staffing. It contains metrics encompassing the U.S. and Europe, major therapeutic areas, and five trial types.

The study enables decision-makers to:

  • Explore key Phase IV benchmarks by company size and geography
  • Build budgets based on concrete benchmarks that enable teams to hit goals and support all studies.
  • Understand and designate clear roles for Phase IV management and activities.

Contact Information

    Elio Evangelista