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Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials
Marcin Makowski1, Ruma Bhagat2, Soazig Chevalier3
1Global Clinical & Data Operations, GlaxoSmithKline GmbH & Co. KG, Prinzregentenpl. 9, 81675, Munich, Germany. Marcin.x.Makowski@gsk.com.
Therapeutic Innovation & Regulatory Science
|August 28, 2021
Summary
Historical data analysis supports quality tolerance limits (QTLs) for clinical trials. Findings show parameter values can establish benchmarks for future trial quality control, aiding regulatory compliance.
Area of Science:
- Pharmaceutical Science
- Clinical Trial Management
- Regulatory Affairs
Background:
- The International Council for Harmonisation updated good clinical practice guidelines in 2016, introducing quality tolerance limits (QTLs).
- TransCelerate previously proposed a framework for implementing QTLs and their parameters.
- Historical data analysis is crucial for setting QTL thresholds in new clinical trials.
Purpose of the Study:
- To analyze historical data for proposed QTL parameters.
- To assess the utility of historical data for establishing QTL benchmarks.
- To compare parameter distributions across therapeutic areas.
Main Methods:
- Analysis of historical data from 294 clinical trials across seven TransCelerate member companies.
- Comparison of Alzheimer's disease (AD) and oncology trials using a Medidata dataset.
- Evaluation of 11 QTL parameters based on available historical data.
Main Results:
- Most QTL parameters showed similar value distributions, with few trials exhibiting high values.
- Analysis of 45 AD and oncology trials using Medidata data revealed no significant therapeutic area differences for three parameters.
- Historical data provided a basis for understanding parameter value distributions.
Conclusions:
- Historical parameter values serve as valuable benchmarks for quality control in upcoming clinical trials.
- The findings support the use of historical data in refining QTL implementation.
- QTLs contribute to enhanced quality control in pharmaceutical development.
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