Four new tools from the Clinical Trials Transformation Initiative (CTTI) help sponsors and sites incorporate quality-by-design (QbD) principles in their trials.

The new tools include a metrics framework for measuring the effects of QbD, a maturity model to assess a site’s readiness to implement QbD and a guide to implementing QbD for individual trials. CTTI also has developed a set of spreadsheets that help plan and document QbD activities.

The new tools join CTTI’s QbD suite, which includes recommendations for monitoring quality assurance, recommendations for incorporating QbD principles, a guide to QbD principles, and a set of templates, guidelines and videos to help implement them.

Advancing QbD is one of five goals CTTI has set for improving clinical trials by 2030 (CenterWatch Weekly, Sept. 21). The other goals are increasing patient-centricity and accessibility, fully integrating clinical research with health processes, leveraging available data and focusing more on improving public health.

Other areas in which CTTI is developing resources include mobile clinical trials, master protocol studies and use of real-world data.

View CTTI’s QbD tools at https://bit.ly/36Xi2LE.