Work

Can quality management drive evidence generation?

Year: 2021

Type: article

Abstract: 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.

Source: Clinical Trials

DOI: 10.1177/17407745211034496

Authors: Ann Meeker-O’Connell, Ansalan Stewart, Coleen Glessner

Institutions: Vertex Pharmaceuticals (United States), United States Food and Drug Administration, Alexion Pharmaceuticals (United States)

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,000