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
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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...