Meeting Background:

At an expert meeting held in October 2010 for the CTTI monitoring project, representatives from a broad cross-section of the clinical trial enterprise—including regulators, government sponsors of clinical research, academicians, industry representatives, patient advocates, clinical investigators, and other interested parties—discussed clinical trial monitoring as one component of an overall quality framework. Panelists and participants agreed that an enlightened approach to ensuring trial quality is needed. Such an approach would apply risk management principles to clinical trials by prospectively identifying critical trial deliverables and important risks to each and then tailoring protocol design and delivery to mitigate those risks. To implement this change, participants agreed that all stakeholders in the clinical trial process must modify their view of risk and have a common understanding of Quality by Design and quality risk management principles. This workshop is the first in a planned series intended to develop Quality by Design and quality risk management principles applicable broadly to clinical trials and development programs, as well as to identify and share best practices for implementing these principles.

Meeting Objectives:

• Develop Quality by Design concepts for the clinical trial process
• Define consensus principles of quality risk management as applied in the drug development lifecycle and in conjunction with Quality by Design concepts
• Review case studies of Quality by Design and quality risk management approaches applied in commercial and academic clinical trial settings, including tools and methodologies and potential best practices
• Discuss methods for evaluating the success of Quality by Design and quality risk management approaches in enhancing the quality and efficiency of clinical development
• Identify mechanisms to disseminate principles and best practices identified during the workshop to a broad array of stakeholders.