Enhancing clinical evidence by proactively building quality into clinical trials

Area of Science:

• Clinical Research
• Evidence-Based Medicine
• Trial Design and Oversight

Background:

• Growing concerns regarding the sustainability of the current clinical trial enterprise due to escalating costs and complexity.
• Increasing trial complexity threatens the generation of reliable evidence for clinical intervention decisions.
• Inefficiencies in clinical trials necessitate improvements in protocol design, planning, and quality oversight.

Purpose of the Study:

• To evaluate methods for prospectively building quality into clinical trial design and operations (quality-by-design).
• To develop principles and practical guidance for enhancing clinical trial feasibility, reliability, and participant safety.
• To address challenges in implementing a proactive, quality-by-design approach in clinical trials.

Main Methods:

• Convened a project to evaluate quality-by-design methods in clinical trials.
• Developed and applied quality-by-design principles through workshops involving cross-functional stakeholders.
• Conducted qualitative interviews to identify implementation challenges for quality-by-design.

Main Results:

• Quality-by-design principles offer a framework for safeguarding participants and ensuring reliable treatment effect data.
• Workshops demonstrated the value of diverse stakeholder input in improving trial design and decision-making.
• Focusing oversight on critical aspects of trials improves participant safety and result reliability.

Conclusions:

• Implementing quality-by-design enables prioritization of critical quality determinants and elimination of non-essential activities.
• Proactive error management (define, avoid, mitigate, monitor, address) is key to efficient and reliable clinical trials.
• Quality-by-design facilitates streamlined trial conduct and oversight, enhancing overall trial quality and sustainability.