Quality By Design

Learn About QbD

QbD Toolkit: Overview, Learn About QbD , Teach Others About QbD, QbD Principles Document, Exploring the CTQ Factors, Workshop Tools, Adopt QbD, How Others are Using QbD, Get Started

QbD Toolkit Resources: Principles Document, CTTI QbD Recommendations, Key Stakeholders, Maturity Model, Metrics Framework, Case Studies

This section of the Toolkit provides an introduction to QbD through videos, downloadable presentations, and peer-reviewed articles. Learn about QbD and why it matters in clinical trials. Leverage these tools to teach others in your organization about QbD in order to secure their interest and support.

CTTI's QbD Recommendations

The CTTI QbD project has produced recommendations on the use and implementation of QbD.

PowerPoint describing QbD

PowerPoint describing QbD

This PowerPoint Slide presentation provides an overview of QbD. It can be downloaded and used to teach your team about QbD.

QbD Publication in DIJ

This publication, Clinical Trials: Rethinking How We Ensure Quality, by Landray, et al. in Drug Information Journal 46(6) 657-660, provides an overview of QbD in Clinical Trials.

Teach Others About QbD

QbD Toolkit: Overview, Learn About QbD , Teach Others About QbD, QbD Principles Document, Exploring the CTQ Factors, Workshop Tools, Adopt QbD, How Others are Using QbD, Get Started

QbD Toolkit Resources: Principles Document, CTTI QbD Recommendations, Key Stakeholders, Maturity Model, Metrics Framework, Case Studies

 QbD is about prospectively examining the objectives of a clinical trial and defining those factors that are critical to meeting those objectives. This requires thinking differently about clinical trials. In order to do that effectively, we have provided tools below to help introduce your team to QbD concepts and how they apply in clinical trials. The sections include: understanding QbD; exploring critical to quality factors (CTQs) through the QbD Principles Document; and applying QbD through workshop tools.

 

Understanding QbD?

For this component, reference the earlier section in the Toolkit on Learn about QbD. You can also review CTTI's QbD Recommendations.

QbD Principles Document

The Principles Document can be used to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality.

Workshop Tools

Hold a workshop to educate attendees about QbD and how to apply the QbD principles through hands-on exercises during breakout sessions. Case studies, facilitator tips, and presentation slide templates are provided. You can also leverage the past CTTI QbD workshop materials.

Adopt QbD

QbD Toolkit: Overview, Learn About QbD , Teach Others About QbD, QbD Principles Document, Exploring the CTQ Factors, Workshop Tools, Adopt QbD, How Others are Using QbD, Get Started

QbD Toolkit Resources: Principles Document, CTTI QbD Recommendations, Key Stakeholders, Maturity Model, Metrics Framework, Case Studies

Understanding QbD is just the beginning. The real impact will occur when QbD is implemented at your organization as part of your fundamental approach to clinical trial design and operationalization. To support you in the work of adopting QbD, we have provided guidance to get started, introduce QbD to your team, and implement QbD.

See How Others Are Using QbD

Learn how other organizations have used CTTI’s QbD recommendations to design and conduct better clinical trials.

Get Started

This section provides insights for getting started and securing buy in within your organization.

Introduce QbD to Your Team

Leverage our tools provided in the sections: Learn about QbD and Teach others about QbD to begin QbD discussions within your organization.

Implement

Adopting QbD take time and effort. In this section, we share tips and insights from others that have implemented QbD to help you in the process.

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.

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.

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:

Defining the Underlying Principles of Quality in Clinical Trials

Approaches to Risk-Based Quality Management

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.

Translating Quality by Design Principles into Practice, Part 1

Webinars | October 10, 2024

Topics Included: Ensuring Quality

CTTI Project: Quality by Design

Webinar Objective

This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about CTTI's QbD Project.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

  • CTTI Quality by Design Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
  • Pfizer Experience by Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
  • Seattle Genetics Experience by Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
  • Q&A

Watch Translating Quality by Design Principles into Practice, Part 2

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