Clinical trial quality: From supervision to collaboration and beyond

Area of Science:

• Clinical Research
• Drug Development
• Regulatory Science

Background:

• Clinical trial quality historically focused on reactive monitoring post-hoc.
• There has been a paradigm shift towards proactive quality management in clinical research.
• Ensuring high-quality evidence generation is paramount for successful drug development.

Purpose of the Study:

• To explore the evolution of clinical trial quality management.
• To highlight the role of the Clinical Trials Transformation Initiative (CTTI) in advancing quality.
• To examine the transition from reactive monitoring to a quality by design (QbD) approach.

Main Methods:

• Review of CTTI's project work and initiatives over the past decade.
• Analysis of the shift in quality management strategies within clinical trials.
• Exploration of the development of a holistic, prospective QbD framework.

Main Results:

• Clinical trial quality is now integrated into the design phase.
• CTTI has been instrumental in promoting a comprehensive quality by design approach.
• The focus has moved from retrospective monitoring to prospective quality assurance.

Conclusions:

• A prospective, quality by design approach enhances clinical trial integrity.
• CTTI's efforts have significantly advanced the adoption of quality by design in clinical research.
• Integrating quality early in trial design leads to more reliable evidence generation.