Quality

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.

Clinical Trials Transformation Initiative Releases New Recommendations and Tools for Improving Patient Recruitment in Clinical Trials

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CTTI Project: Recruitment

CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment that are now available to download. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.

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