Designed with Quality Approach

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.

Designing High-Quality COVID-19 Treatment Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Pamela Tenaerts (Clinical Trials Transformation Initiative)
  • Janet Woodcock (FDA, CDER)
  • Ed Cox (Regeneron Pharmaceuticals, Inc.)
  • Martin Landray (University of Oxford)
  • John Marshall (WHO Clinical Characterization and Management Working Group, Unity Health CA)
  • Karlin Schroeder (Parkinson's Foundation)
  • Fergus Sweeney (European Medicines Agency)
  • Ann Meeker O'Connell (Vertex Pharmaceuticals)

PDF icon Download Slides

 

 

Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Greg Pennock, EMD Serono
  • David Rodin, Amici Clinical Research
  • Ansalan Stewart, FDA
  • Karlin Schroeder, Parkinson’s Foundation
  • Steve Young, CluePoints

Webinar Resources:

Download Powerpoint Slideset

Resources:

 

New CTTI Project to Develop Common Framework to Assess Progress Towards TT2030 Vision

Posted on by Hannah Faulkner

Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials need to be patient centered and easily accessible, fully integrated into health processes, designed with a quality approach, maximally leveraging all available data, and improving population health. Currently, the TT2030 vision lacks metrics to demonstrate progress towards the vision’s five central goals. The Measuring Trials Transformation (MTT) Project will develop a common framework to evaluate and assess the progress made towards achieving the five main goals of the TT2030 vision, a framework that can be used to share accountability across the clinical trials enterprise.  

After launching the TT2030 vision, CTTI conducted concept elicitation interviews to develop key concepts metrics should address within each pillar. In 2022 and early 2023, CTTI conducted surveys of experts to assess the value of individual metrics for assessing progress towards the vision. 

To deploy a set of relevant metrics, CTTI will utilize a variety of iterative strategies, including interviews with key stakeholders on their experiences with each pillar and ideas for related metrics, expert surveys on draft measures for each pillar, and an online public forum on the measurement framework. The selected metrics will be further refined by integrating public comment, expert input, and project team feedback and discussions. CTTI will perform a case study using the framework of metrics to measure progress towards the TT2030 vision by collecting and reporting an initial set of metrics using recent clinical trials.   

CTTI understands that some goals of the TT2030 vision will be achieved sooner than others, and so the framework created by the MTT Project will establish key milestones to assess progress made by the program over time. CTTI will use this vision to guide their priorities, and they will encourage others to do the same, facilitating accountability across the entire clinical trials industry.  

The Metrics Framework is currently open for public comment until mid-October 2023. Please view the dashboard and provide your suggestions and feedback here.