Background

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}

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

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