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New Case Studies Reveal Real-World Experience with Quality by Design (QbD)

Organizations are gaining experience using CTTI’s Quality by Design (QbD) recommendations to design and conduct better clinical trials. CTTI today announced four new QbD case studies, adding to its robust QbD toolkit. Three of the case studies are also now featured in CTTI’s recently-announced Building Better Clinical Trials: A Case Study Exchange resource.

The case studies provide an in-depth look at real-word implementation of QbD principles by:


  • Alexion, a biopharmaceutical company focused on developing medicines for rare diseases, applied QbD principles early in study design to build a streamlined, simple protocol for a global Phase III trial on a tight timeline.
  • An investigator at the Duke Clinical Research Institute applied QbD principles to thoughtfully and strategically design a 1,000 patient, multicenter trial that can be largely executed remotely.
  • The Medicines Company (now part of Novartis), a small pharma company that applied QbD principles with two collaborators to plan a 5-year trial that is already seeing faster-than-expected recruitment.
  • University of Oxford’s Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) followed a QbD approach in planning and conducting a streamlined, mail-based trial that enrolled over 15,000 participants.

QbD is not a checklist, rather it is a common sense approach in which stakeholders consider: (1) what aspects of a trial are critical to generating reliable data and providing appropriate protection of research participants (“critical to quality” factors); and, (2) what strategies and actions will effectively and efficiently support quality in these critical areas.


These new case studies not only describe the critical-to-quality factors for each trial, and how they were addressed, but also provide tangible strategies and examples for how other organizations can implement such an approach.      

This news comes on the heels of CTTI announcing:


  • New resources for the adoption of a QbD approach – including a QbD Maturity Model, Metrics Framework, Implementation Guide, and Documentation Tool – at the end of 2020; and
  • Building Better Clinical Trials: A Case Study Exchange, announced in March 2021; three of the case studies announced today will be included in this resource.

Want to be featured on Building Better Clinical Trials: A Case Study Exchange?

If you are part of an organization that has used any of CTTI’s recommendations or tools and would like to be featured on the site, we may be able to include your story.

By sharing your experience, you can showcase your organization’s success while providing helpful information that will benefit other organizations and facilitate collaboration and knowledge sharing across the research community.

Please reach out to Karisa Merrill to learn more.