Document Actions
Workshops on Quality-by-Design in Clinical Trials
Up one levelBackground
A key conclusion of the CTTI monitoring project was that clinical trial monitoring should be viewed as one component of an overall quality framework. Project participants, representing a broad cross-section of the clinical trials enterprise, agreed that widespread adoption of an enlightened approach to trial planning, conduct, and oversight is needed to ensure trial quality and efficiency. Such an approach would apply risk management principles to clinical trials by prospectively identifying critical trial deliverables and important associated risks and then tailoring protocol design and delivery to mitigate those risks. The term “quality-by-design” (QbD) is being used to describe this new approach to clinical trials, borrowing concepts from an effort dubbed “QbD” within the pharmaceutical manufacturing sector which has successfully applied similar principles.1, 2, 3
Goal
Explore ways to apply principles of quality-by-design and quality risk management to the scientific and operational design of clinical trials
The key objectives of the quality-by-design project include the following:
- Develop consensus on QbD and risk management principles for clinical trials of drugs, devices, and biologics
- Review case studies demonstrating application of these principles in trials sponsored by industry, government, or academia, including tools and methodologies
- Discuss methods for evaluating the success of QbD approaches in enhancing the quality and efficiency of clinical trials.
- Identify mechanisms to disseminate to a broad array of stakeholders agreed principles and promising approaches identified during the workshops.
Methods
A series of workshops or expert meetings will be held to develop QbD and risk management principles that are broadly applicable to clinical trials, as well as to identify promising approaches to implementing these principles. In August 2011, the first workshop was held and included participants from a broad array of stakeholders, with representatives from national and international regulatory authorities, industry (pharmaceutical, biotech, device, and contract research organizations), academic institutions, government agencies, investigator groups, and patient advocates.
Results
The first workshop was held August 23-24, 2011
- Executive Summary
- Meeting Summary
- Click here to view the agenda, presentations and participants
Funding and Other Support
Financial support is being provided by Grant # U19 FD003800 from the U.S. Food and Drug Administration (FDA). Volunteer time has been provided by Pfizer, the European Medicines Agency, and FDA.
Contact Information
Please send your questions or comments to
1 International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: pharmaceutical development Q8 (R2), current step 4 version (ICHQ8, August 2009). Accessed at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf on November 10, 2011.
2 ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: quality risk management, current step 4 version (ICHQ9, November 2005). Accessed at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdfon November 10, 2011.
3 ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: pharmaceutical quality systems, current step 2 version (ICHQ10, May 2007). Accessed at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128031.pdfon November, 11, 2011.
View Entire Calendar