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Benchmarking Site Activation and Patient Enrollment
Mary Jo Lamberti1, Abigail Dirks2, Nicholas Kikuchi3
1Tufts Center for the Study of Drug Development, Tufts University, 145 Harrison Avenue, Boston, MA, 02111, USA. mary_jo.lamberti@tufts.edu.
Therapeutic Innovation & Regulatory Science
|April 3, 2024
Summary
Clinical trial patient enrollment benchmarks were updated, revealing that actual patient enrollment frequently surpassed planned targets and timelines were shorter than anticipated. These findings offer valuable insights for optimizing clinical trial operations.
Area of Science:
- Clinical research operations
- Drug development
- Healthcare management
Background:
- Clinical trial conduct faces significant hurdles, particularly in patient recruitment.
- Previous studies by Tufts CSDD established benchmarks for site activation and patient enrollment.
Purpose of the Study:
- To update established benchmarks for clinical trial site activation and patient enrollment.
- To evaluate current strategies for patient recruitment and retention in clinical trials.
- To analyze trends in enrollment metrics across different time points.
Main Methods:
- Data collection focused on site activation and patient enrollment metrics.
- Comparative analysis of data from 2012, 2019, and 2023.
- Examination of enrollment achievement across global regions and site types.
Main Results:
- A majority of studies exceeded planned patient enrollment targets.
- Actual clinical trial timelines were generally shorter than initially projected.
- Significant variations in enrollment achievement were observed based on global region and the type of research site.
Conclusions:
- Current clinical trial enrollment performance indicates a positive trend, with actuals often exceeding plans.
- Timelines for clinical trials may be shorter than historically benchmarked.
- Further research is recommended to analyze post-pandemic trial data against current benchmarks.
