Related: Quality By Design Archives

New Recommendations to Improve Quality in Clinical Trials

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CTTI has issued recommendations and an associated toolkit to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not.

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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:

Introduction by Pamela Tenaerts

SESSION I: Landscape, Rationale And Principles

Quality Risk Assessment and Quality by Design in Clinical Research by Martin Landray
How US Regulatory Requirements Contribute to Study Quality by James Saviola
European Perspective on Quality by Angeles Alonso Garcia
Current issues in device development and approval – Industry perspective by Ted Lystig
Current issues in device development and approval – Academic perspective by Laura Mauri
Payor perspective on quality by Louis Jacques

SESSION II: Real‐World Examples

CoreValve U.S. Pivotal Trial by Ted Lystig
TASTE: Thrombus aspiration during ST-‐segment elevation myocardial infarction - A multi-center, prospective, registry based randomized clinical trial by Roxana Mehran
SAFE-PCI: The Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women by Sunil Rao

SESSION III: Providing Guidance

Principles Document Review by Ann Meeker-O’Connell

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

Introduction by Robert J. Temple

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

Monitoring Workstream #3 Key Findings by Briggs Morrison
Learning from Quality by Design in the Manufacturing Sector by Fergus Sweeney
Principles of Quality Risk Managementby Beat Widler

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

Regulatory Agencies and Quality in Clinical Trials Risk Adaptive Approach by Kathleen Meeley
Regulatory Agencies and Quality in Clinical Trials by Pierre Henri Bertoye
What we can do to Ensure the Quality by Tomoko Osawa
CDER Perspective: Challenges in Clinical Trials and the Path Forward by Ann Meeker-O'Connell

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

Building Quality into Clinical Development: The Academic Perspective

Quality in clinical trials: What really matters? by Rory Collins
Building Quality into Clinical Development: ASCEND-HF as a Case Example by Adrian Hernandez and Craig Reist

Building Quality into Clinical Development: The Pharmaceutical Industry Perspective

Building Quality into Clinical Trials – A Pilot with the FDA by David Nickerson
Medical Quality by Design: The Journey Continues by Jeff Kasher
Workshop on Quality Risk Management Making Trials Fit for Purpose by Andrew Lee
Facilitated Clinical Reviews – An Approach For Better Quality Protocols by Craig Wozniak
Risk Based Approach – Case Study by Andy Lawton
Clinical Trial Quality by Design Case Study − A Small Company Experience by Lynn Seely

Building Quality into Clinical Development: Outsourcing

CRO Point of View by Regina Freunscht
Building Quality into Clinical Development: Outsourcing by Ken Getz

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.

Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach

OCTOBER 13, 2010 TO OCTOBER 14, 2010

CTTI Project: Quality by Design

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 Location:

Bethesda Marriott Suites, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

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.

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