Formats

Workshop on Quality Risk Management: Understanding What Matters

JANUARY 29, 2014 TO JANUARY 30, 2014

CTTI Project: Quality by Design

Meeting Background:

This meeting continued the CTTI workshop series, conducted to evaluate, and allow participants to practice, application of Quality by Design (QbD) principles to clinical trials. The January 2014 workshop focused specifically on applying QbD principles in medical device and diagnostic trials.

Quality by Design emphasizes building quality into a process from the beginning. Applied in clinical development, this approach prospectively examines the design and objectives of trials and identifies “critical to quality” factors (e.g. key data and trial processes such as randomization). Understanding what aspects of a trial are “critical to quality” is essential to subsequently identifying and managing important and likely risks to trial quality. These risks can be managed through modifying trial design, tailoring its implementation, and providing sensible, risk-based oversight. These approaches also have the potential to improve clinical trial efficiency. Focusing on critical aspects of a trial could substantially reduce the burden of clinical trial conduct by relieving sponsors of a perceived obligation to mitigate every potential risk posed by a trial, especially for those activities that minimally affect data quality and human subject protection.

Meeting Objectives:

  • Develop understanding of risk-based Quality by Design for clinical trials, from general principles, real-‐world examples, and hypothetical case studies
  • Gain confidence in the application of such concepts to clinical trials
  • Identify obstacles to the adoption of this approach
  • Identify opportunities for dissemination of these principles and practices to a broad array of stakeholders

Meeting Location:

DoubleTree, Bethesda, MD

Meeting Materials:

Meeting Summary

Principles Document

Meeting Agenda

List of meeting attendees

Meeting Presentations:

SESSION I: Landscape, Rationale And Principles

SESSION II: Real‐World Examples

SESSION III: Providing Guidance

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.

Use of Central IRBs for Multi-center Clinical Trials

APRIL 25, 2012 TO APRIL 26, 2012

CTTI Project: Single IRB

Meeting Background:

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multi-center trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections recommending this approach. The goal of the CTTI project is to identify potential solutions to address barriers to the adoption of central IRBs for multi-center clinical trials.

Meeting Objectives:

  • Present research findings from the CTTI project entitled, Use of Central IRBs for Multi-center Clinical Trials
  • Discuss research findings among experts present at the meeting
  • Solicit additional feedback to refine proposed solutions

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

*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.

Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose

AUGUST 23, 2011 TO AUGUST 24, 2011

CTTI Project: Quality by Design

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.

Meeting Location:

Hyatt Regency Bethesda, Bethesda, Maryland

Meeting Materials:

Executive Summary

Detailed, General Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

WELCOMING REMARKS

SESSION I: PRINCIPLES FOR BUILDING QUALITY INTO CLINICAL TRIAL DEVELOPMENT
Session Facilitators: Leslie and Peter (lead)

SESSION II: REGULATORS' PANEL
Session Facilitators: Fergus and Leslie (lead)

SESSION III: CASE STUDIES
Session Facilitators: Peter (lead), Fergus, and Ann

Building Quality into Clinical Development: The Academic Perspective

Building Quality into Clinical Development: The Pharmaceutical Industry Perspective

Building Quality into Clinical Development: Outsourcing

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.