ArticleTherapeutic innovation & regulatory science2021
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials.
Article in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Efficient Positioning of QTL and Secondary Limit Thresholds in a Clinical Trial Risk-Based Monitoring.Therapeutic innovation & regulatory science · 2025Article
- Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting.Therapeutic innovation & regulatory science · 2024Article
- An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits.Therapeutic innovation & regulatory science · 2024Review
- Quality Tolerance Limits' Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters.Therapeutic innovation & regulatory science · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
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