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Development of the clinical trial site performance metrics instrument: A study protocol
Mattia Bozzetti1, Rosario Caruso2,3, Silvia Soncini4
1Department of Biomedicine and Prevention, University of Rome, Tor Vergata, Italy.
Methodsx
|February 3, 2025
Summary
This study introduces a new Clinical Trial Site Performance Measure (CT-SPM) to standardize site evaluation in multicenter clinical trials. The validated tool will improve efficiency and quality in research, reducing costs.
Area of Science:
- Clinical research methodology
- Health services research
- Biostatistics
Background:
- Clinical trials are critical for medical progress but face challenges in efficiency and cost.
- Inconsistent evaluation of site performance in multicenter studies hinders effective trial management.
Purpose of the Study:
- To develop and validate a Clinical Trial Site Performance Measure (CT-SPM) for assessing "good performance" in clinical trials.
- To create both a comprehensive and a short-form version of the CT-SPM for broad applicability.
- To establish a standardized method for evaluating clinical trial site performance.
Main Methods:
- Phase 1: Metric selection via expert consensus.
- Phase 2: Psychometric testing for reliability and validity of the CT-SPM.
- Phase 3: Statistical modeling to define a "good performance" cut-off.
Main Results:
- Development of a validated Clinical Trial Site Performance Measure (CT-SPM).
- Creation of a comprehensive scale and a short-form version for diverse applications.
- Establishment of a statistically defined cut-off for "good performance" in clinical trial sites.
Conclusions:
- The CT-SPM offers a standardized approach to evaluating clinical trial site performance.
- This measure can enhance the quality and efficiency of multicenter clinical trials.
- Standardized performance evaluation has the potential to reduce research costs and improve trial outcomes.
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