Abstract
BackgroundIn 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.MethodsThis 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.ResultsTransCelerate 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.ConclusionHistorical parameter values can provide helpful benchmark information for quality control activities in future trials.
Highlights
In 2016, International Council for Harmonisation of Tech‐ nical Requirements for Pharmaceuticals for Human Use (ICH) E6 introduced quality tolerance limits (QTLs) as a quality control in clinical trials
Clinical trials targeting specific indications were selected from the Medidata Enterprise Data Store (MEDS), com‐ prised of 22,000 + historical clinical trials, for de-identified aggregate analyses
In contrast to the parameters pertaining to missing data, the public domain information on eligibility-related and other protocol devia‐ tions (PDs) is very scarce and different from the results reported here
Summary
In 2016, International Council for Harmonisation of Tech‐ nical Requirements for Pharmaceuticals for Human Use (ICH) E6 introduced quality tolerance limits (QTLs) as a quality control in clinical trials. Each clinical trial sets QTLs by defining the parameters to be observed, the units of measure, the data source(s), and their initial limit(s). 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. 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. 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
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