Objectives/Goals: To implement and evaluate the Quality by Design (QbD) framework integrating team science and project management to increase quality and efficiency in clinical and translational studies. Goals include achieving 80% on-time completion and sharing tools to expand QbD use across other CTSA hubs. Methods/Study Population: The SC CTSI launched the QbD program in 2022 to support pilot grants, KL2 Scholar projects, and other CTSI-funded studies. Program elements include 1) Design Studios, facilitated by a QbD Specialist and attended by interdisciplinary advisors, to anticipate risks to timely study completion; 2) ongoing project management with regular check-ins; and 3) team science support for multidisciplinary research teams. Study teams establish milestones and track risks across the timeline. Ongoing evaluation follows studies across a wide variety of disease areas, using mixed methods to assess feasibility, perceived value, and impact on scientific productivity and institutional culture. Results/Anticipated Results: The QbD program has been delivered consistently, demonstrating it is feasible and well-received, with 93% of PIs reporting QbD as valuable for identifying risks and refining protocols. Early evidence suggests QbD support may reduce delays, with shorter extensions, while common barriers stemmed from institutional and administrative hurdles. PI interviews highlight QbD as a constructive framework for strengthening early planning and risk mitigation, with feedback prompting ongoing refinement such as adjusting the timing of Design studios. Anticipated results include continuous evaluation outcomes, ongoing program improvements, and broader dissemination with other CTSA hubs. Discussion/Significance of Impact: Evaluation will clarify how QbD implementation influences study planning and risk mitigation to prevent delays. Broader outcomes will include toolkit development and fostering a culture to advance proactive, quality-focused research services across institutions.
Huang et al. (Wed,) studied this question.