Clinical Trials: Building Quality At The Start Means Reducing Errors That Matter

06 Feb 2024

Despite encouragement from regulators, quality-by-design and risk-based monitoring approaches for clinical trials have not been fully adopted. Experts say careful, cross-disciplinary thinking is needed in the study design phase, along with adoption of the quality mentality seen on the manufacturing side.

Young plant — Quality should be built into clinical trials from the start. • Source: Shutterstock (Shutterstock)

Building quality into clinical trials up-front requires careful, cross-disciplinary thinking during the design phase about the most important risks to a study and adoption of the type of quality mindset that guides pharmaceutical manufacturing, experts said.

Key Takeaways

US and international regulators are encouraging incorporation of quality-by-design and risk-based monitoring approaches into clinical trials, but a risk-averse industry has been slow to embrace them outside the COVID-19 pandemic.

Regulators, industry representatives, clinical trial experts and patient advocacy groups discussed successes and challenges in integrating quality-by-design (QbD) and risk-based...