As part of its ongoing commitment to improving the quality and efficiency of clinical trials, the Clinical Trials Transformation Initiative (CTTI) has launched two new resources to help clinical research teams apply Quality by Design (QbD) principles throughout trial design and development.  
 
Introduced during a public webinar on October 7, the Collaborative Engagement in Clinical Trial Design Roadmap and Introduction to Quality by Design Training Module provide practical guidance for incorporating QbD principles into clinical trial development. 
 
Applying QbD principles early in trial development helps research teams proactively identify risks, engage essential contributors, and focus on factors critical to trial quality. These approaches can lead to more efficient, feasible, and participant-centered clinical trials. 
 
The Collaborative Engagement in Clinical Trial Design Roadmap provides stage-specific guidance for engaging essential contributors throughout protocol development, while the Introduction to Quality by Design Training Module offers foundational knowledge to support a shared understanding and consistent application of QbD principles across clinical development teams. 
 
Together, these resources aim to help research teams incorporate a range of perspectives, address potential challenges early, and design trials that prioritize participant safety, data integrity, operational feasibility, and meaningful outcomes.

More information about these resources and the webinar recording is available on CTTI’s website.