Protocol for applying an enhanced quality-by-design program across the translational science spectrum

The quality by design (QbD) framework holds promise for improving success rates for completion of clinical studies, which often fail to complete on time. Initially used in manufacturing, the framework is now frequently applied to clinical trials to anticipate risks and avoid challenges that impact study completion or the credibility of results. The Southern California Clinical and Translational Science Institute created and implemented a program based on QbD to increase the success of research studies, including clinical trials and other study designs, being conducted by scholars in our Mentored Career Development Program and awardees in our Pilot Grant Programs. The program's three components are QbD Design Studios, project management, and team science support. The overall goal is to increase study quality and efficiency, thereby improving study completion success rates and, ultimately, driving innovations in healthcare and public health. The current article describes QbD program elements in detail, along with preliminary results from initial implementation, approaches for evaluating the program's implementation and impact on study success, and plans to disseminate the program widely.