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

Area of Science:

• Clinical Trials
• Translational Science
• Healthcare Innovation

Background:

• Clinical studies frequently face delays, impacting completion rates and data credibility.
• The Quality by Design (QbD) framework, initially from manufacturing, is increasingly applied to clinical trials to mitigate risks.
• Research institutions are implementing QbD to enhance study success and efficiency.

Purpose of the Study:

• To describe a Quality by Design (QbD) program implemented at the Southern California Clinical and Translational Science Institute.
• To detail the program's components: QbD Design Studios, project management, and team science support.
• To present preliminary results and evaluation strategies for the QbD program's impact on study completion.

Main Methods:

• Implementation of a structured QbD program for mentored scholars and pilot grant awardees.
• Integration of QbD Design Studios, dedicated project management, and team science support.
• Development of approaches to evaluate program implementation and its effect on study success.

Main Results:

• Preliminary data indicates the QbD program's potential to improve study quality and efficiency.
• The program aims to increase clinical study completion rates.
• Early implementation suggests QbD can positively influence research outcomes.

Conclusions:

• The QbD framework offers a promising approach to enhance clinical trial success.
• The described QbD program has the potential to increase research efficiency and study completion rates.
• Dissemination of this QbD program can drive healthcare and public health innovations.