Can quality management drive evidence generation?

Area of Science:

• Clinical trial methodology
• Regulatory science
• Quality management systems

Background:

• International regulators highlight thoughtful trial design and risk-based oversight for reliable results.
• Current implementation of these recommendations is often fragmented, limiting effectiveness.
• Modernizing quality management requires a unified approach to trial design and oversight.

Purpose of the Study:

• To advocate for collaborative, cross-stakeholder engagement to modernize clinical trial quality management.
• To demonstrate the applicability of Quality by Design (QbD) beyond regulatory drug approval trials.
• To highlight QbD's role in ensuring trial credibility and participant safety.

Main Methods:

• The study emphasizes a Quality by Design (QbD) framework.
• QbD involves proactive identification and mitigation of errors impacting trial credibility or safety.
• The approach integrates optimal trial design with tailored oversight.

Main Results:

• Collaborative engagement is presented as a necessary and effective strategy.
• Quality by Design is shown to be a core component of this modernization.
• The QbD approach is adaptable to various trial types, including pragmatic trials.

Conclusions:

• A collaborative, cross-stakeholder approach prioritizing optimal design and tailored oversight is essential for modernizing quality management.
• Quality by Design offers a robust framework for ensuring clinical trial reliability and participant safety.
• The QbD methodology is applicable and beneficial for both traditional regulatory trials and pragmatic research, including pandemic-related studies.