T 40: What’s in a Number? Differences in Enrollment Rate Calculation Methodologies for Clinical Trial Planning
Poster Presenter
Earl Seltzer
Senior Director, Partnerships and Innovation
CTI United States
Objectives
Understand limitations associated with using publicly available data to estimate prior trial recruitment rates
Method
For all studies with evaluable metrics conducted at Quintiles in the past 5 years, we compared internally calculated enrollment rates with enrollment rates determined using available public data
Results
Calculating enrollment rates using individual site and country enrollment periods provides different recruitment rates than available through public sources. In some cases these differences in rates are substantial and could have significant implications on enrollment assumptions associated with clinical trial planning
Conclusion
Using prior data to estimate enrollment rates is a hallmark of planning for clinical trials. However, the specific methodology and sources of study milestones used to calculate such rates can lead to substantial differences in estimates used for study planning. Depending on the available information regarding numbers of and location of sites, countries, study timelines and other variables, enrollment rates may be substantially different than what was actually experienced in the study. The implications of this are inaccurate projections for study timelines, which may impact budget forecasting, study resourcing, and project management, as well as any services that are associated with patient accrual into clinical trials.
