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. 2021 Nov;55(6):1265-1273.
doi: 10.1007/s43441-021-00335-3. Epub 2021 Aug 27.

Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials

Marcin Makowski  1 , Ruma Bhagat  2 , Soazig Chevalier  3 , Steven A Gilbert  4 , Dagmar R Görtz  5 , Marta Kozińska  6 , Patrick Nadolny  7   8 , Melissa Suprin  9 , Sabine Turri  10
Affiliations

Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials

Marcin Makowski et al. Ther Innov Regul Sci. 2021 Nov.

Abstract

Background: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced quality tolerance limits (QTLs) as a quality control in clinical trials. Previously, TransCelerate proposed a framework for QTL implementation and parameters. Historical data can be important in helping to determine QTL thresholds in new clinical trials.

Methods: This article presents results of historical data analyses for the previously proposed parameters based on data from 294 clinical trials from seven TransCelerate member companies. The differences across therapeutic areas were assessed by comparing Alzheimer's disease (AD) and oncology trials using a separate dataset provided by Medidata.

Results: TransCelerate member companies provided historical data on 11 QTL parameters with data sufficient for analysis for parameters. The distribution of values was similar for most parameters with a relatively small number of outlying trials with high parameter values. Medidata provided values for three parameters in a total of 45 AD and oncology trials with no obvious differences between the therapeutic areas.

Conclusion: Historical parameter values can provide helpful benchmark information for quality control activities in future trials.

Keywords: Clinical trials; Historical data; QTL; Quality tolerance limits; Thresholds.

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Conflict of interest statement

The authors declare no conflicts of interest. However, all authors are employees and/or stockholders of the companies with which they are affiliated.

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