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

Allison Zumberge Orechwa1, Leslie Aguilar1, Megan Castiel1

  • 1Southern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.

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Quality by Design (QbD) improves clinical study success by anticipating risks. A new QbD program enhances research quality and efficiency, leading to better healthcare innovations.

Keywords:
Translational scienceclinical research efficiencyoperationsquality by design (QbD)risk-based monitoring

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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.