Can quality management drive evidence generation?

Recent guidance documents from international regulators emphasize the importance of thoughtful trial design and risk-based oversight in delivering reliable results. In practice, these recommendations are often implemented in a fragmented manner, reducing their effectiveness. We argue that collaborat...

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Bibliographic Details
Published in:Clinical trials (London, England) England), 2022-02, Vol.19 (1), p.112-115
Main Authors: Meeker-O’Connell, Ann, Stewart, Ansalan, Glessner, Coleen
Format: Article
Language:English
Subjects:
Clinical trials
Design
International regulations
Medical research
Modernization
Pandemics
Quality management
Regulatory approval
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Summary:Recent guidance documents from international regulators emphasize the importance of thoughtful trial design and risk-based oversight in delivering reliable results. In practice, these recommendations are often implemented in a fragmented manner, reducing their effectiveness. We argue that collaborative, cross-stakeholder engagement that prioritizes both optimal trial design and tailored oversight are a necessary and effective approach to modernize quality management. This practice is at the core of Quality by Design, an approach that involves identifying important errors that could undermine trial credibility or participant safety and addressing them proactively. While Quality by Design is well suited for clinical trials supporting regulatory approval of a new medicinal product, we describe how the approach is equally relevant for pragmatic trials, including those conducted in the context of a pandemic.
ISSN:1740-7745
1740-7753
DOI:10.1177/17407745211034496