Quality By Design

CTTI to Release New Resources for Adoption of a Quality by Design Approach During Nov. 12 Webinar

Posted on by Hannah Faulkner

CTTI will host a public webinar, Accelerating Evidence Generation: New CTTI Resources for Implementing a QbD Approach to Clinical Trials, on Thurs., Nov. 12.

“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing, and thus demonstrating the value of Quality by Design,” said CTTI Executive Director Pamela Tenaerts, MD, MBA. “These new tools aim to help researchers implement QbD into their trial – an efficient approach that will help them focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.”

The specific resources that CTTI will release include:

  • QbD Maturity Model: This self-assessment tool can be used by organizations to assess their current implementation of QbD, and to identify a desired future state.
  • Metrics Framework: This QbD Metrics Framework provides nine example metrics that can help key stakeholders in clinical research organizations to self-evaluate QbD implementation and guide continuous improvement efforts.
  • Implementation Guide: This resource helps study teams plan and evaluate their implementation of QbD for an individual clinical trial, and is intended to serve as a guide to key elements of QbD that will often be important to incorporate in trial planning and execution.
  • Documentation Tool: This tool helps study teams capture and communicate decisions about what is critical to quality and how the most important risks will be addressed.

These new resources expand CTTI’s existing QbD toolkit, which serves as a one-stop-shop for any individual or organization looking to implement QbD, and may help meet the anticipated new guideline for ICH E8(r1), which is expected to be finalized in 2021 and emphasizes a QbD approach to trial design.

The free public webinar will begin at noon EST on Thurs., Nov. 12 and will feature the following presenters:

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

Recording Now Available: Designing High-Quality COVID-19 Treatment Trials

Posted on by Hannah Faulkner

Designing clinical trials during a pandemic presents significant challenges. However, it is possible to build trials that yield high-quality results without slowing down the process.

In a webinar from Thurs., April 23, titled “Designing High-Quality COVID-19 Treatment Trials,” a diverse group of stakeholders presented perspectives that can inform COVID-19 researchers on best practices for designing and quickly launching trials that improve quality and minimize burdens on front-line hospital staff and study participants. The slide deck and recording from this webinar are now available here.

This is the second in a series of CTTI webinars designed to provide help and direction to those seeking to improve trials related to COVID-19. The first webinar, “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic,” is available here.

CTTI to Host Webinar on Designing High-Quality COVID-19 Treatment Trials

Posted on by Hannah Faulkner

As the research community races to identify safe and effective COVID-19 therapies, researchers are in need of accelerating trial design without sacrificing quality. The Clinical Trials Transformation Initiative (CTTI) will discuss designing high-quality COVID-19 treatment trials via a webinar Thursday, April 23 at 9:30 ET.

Speakers will include:

  • 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

During the webinar, COVID-19 researchers will glean best practices for designing trials that are streamlined, high-quality, and minimize burdens on front-line hospital staff and study participants.