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.