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CLICK HERE for the Executive Summary.

Meeting Background

The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify effective and efficient methods to monitor clinical trials. In seeking to identify how best to ensure the reliability of study results and the protection of trial participants, the project team has recognized that quality cannot be “inspected into” a trial but rather must be incorporated from the outset in the trial’s protocol design and operational conduct. To be effective, monitoring should be one component of an overall quality framework that allows potential issues to be identified and addressed as early as possible.

Meeting Objectives

• Describe, discuss, and evaluate novel approaches to clinical trial oversight
• Propose an integrated model of quality management that will promote more efficient approaches to design, conduct and oversight of clinical trial
• Identify the critical aspects of clinical trials that should be the focus of risk-based approaches to creating quality systems

Meeting Presentations*

• CTTI Background by Martin Landray

Defining the Underlying Principles of Quality in Clinical Trials

• Quality Design of Trials by Rory Collins
• Quality Risk Management in Clinical Trials by Janet Woodcock
• Statistical Monitoring Applied to Research Trials by Tomasz Burzykowski

Approaches to Risk-Based Quality Management 

• Quality by Design/Quality Designs by Beat Widler
• Clinical Data Mining as a Basis for an Information-Based Clinical QA Program by Grant Simmons
• Quality System Approaches Using Existing Data and Systems by Eileen Magruder
• Quality Risk Management Tools by Raffael Jovine
• The NIH/NCI Data Quality Initiative by Edward Helton
• An Academic Approach: Combining Quality by Design with Central Monitoring by Martin Landray
• FDA's Risk-Based Inspection by Leslie Ball
• Risk-Based Quality Management of Clinical Trials - A European Regulator's View by Gabriele Schwarz

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.