>> Project Summary

Clinical Trial Investigational Plan

Workshops on Quality by Design (QbD) and Quality Risk Management (QRM) in Clinical Trials

Project Status: Current


Quality by Design (QbD), an approach that has been successful in the manufacturing arena, emphasizes building quality into a process from the beginning.  Applied in clinical development, this approach would prospectively examine the objectives of a trial and define factors (key data and trial processes such as randomization) critical to meeting these objectives.  Understanding what data and processes underpin a successful trial is essential to subsequently identifying and managing important and likely risks to trial quality. These risks would then be managed through tailoring trial design, implementation, and sensible, risk-based oversight.

Participants in an inaugural CTTI workshop on “Quality Risk Management: Making Clinical Trials Fit for Purpose” held in August 2011 explored principles of risk management and QbD from other disciplines and examined how such principles could be adapted to enhance clinical trial design and execution.  Participants generally agreed that these approaches have the potential to improve clinical trial efficiency while enabling sponsors and clinical investigators to meet their fundamental obligations to protect individuals who volunteer for research and to oversee their trials.  In particular, these approaches reposition monitoring as one tool for ongoing evaluation and improvement.  Focusing on critical aspects of a trial could also 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.


What is the issue?

Current models for clinical trial design, implementation and oversight may have become outmoded and unsustainable in a global, complex clinical trial environment. In particular, existing oversight models, which generally rely on frequent, on-site monitoring visits by sponsor personnel, may not optimally address the most critical risks to trial integrity. A key conclusion of the Clinical Trials Transformation Initiative (CTTI) Monitoring Project was that clinical trial monitoring should be viewed as one component of an overall quality framework. Project participants, representing a broad cross-section of the clinical trials enterprise, agreed that widespread adoption of an enlightened Quality by Design approach to trial planning, conduct, and oversight is needed to ensure trial quality and efficiency. Such an approach would apply risk management principles to the design and execution of clinical trials.


What is the goal of this project?

Develop methods to apply principles of Quality by Design and quality risk management to the scientific and operational design of clinical trials


What are the objectives of this project?

The key objectives of the QbD Project include the following:

  • Develop broad principles for QbD and risk management applicable across clinical trials.  
  • Review case studies demonstrating how these principles are being applied in trials sponsored by industry, government, or academia to enhance trial design, implementation, and oversight
  • Provide hands-on opportunities for stakeholders involved in clinical trial development, implementation, and oversight to translate QbD and risk management principles into practice
  • Explore methods for evaluating the success of QbD approaches in enhancing the quality and efficiency of clinical trials.  
  • Identify mechanisms to disseminate agreed principles and promising approaches identified during the workshops to a broad array of stakeholders.


What has the project accomplished?

We held our first QbD workshop in August of 2011, and worked with stakeholders in the industry to develop a Principles Document describing how to apply ideas from Quality by Design to clinical trial design. We held additional workshops in September of 2012 and January 2013 to seek input on the Principles Document, and to provide participants with an opportunity to practice using the principles to design a trial working with case studies from various medical specialties. To date approximately 200 attendees have participated in QbD workshops.


What are the next steps?

We are in the planning stages for additional workshops. We continue to disseminate information about QbD principles through public presentations and word of mouth. We plan to create a forum in which former workshop attendees can share information about implementing QbD principles in their clinical trial planning processes.


Snapshot of CTTI's QbD Project

Snapshot of CTTI's QbD Project


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