A recent CTTI webinar brought together stakeholders from across the clinical trials enterprise for an overview of Quality by Design (QbD), existing CTTI resources, and how QbD is being implemented in the real world.
QbD is defined as the absence of “errors that matter”—or, those errors that could jeopardize the ability to 1) protect patients during the trial, and 2) obtain reliable results and meaningful information from the trial. CTTI started working on QbD in 2011, with a focus on addressing ineffective clinical trial monitoring. It was determined that monitoring should be viewed as only one component of an overall quality framework. From there, CTTI went on to develop a broad set of evidence-based recommendations and resources to help drive adoption of QbD.
During the webinar, CTTI walked stakeholders through its QbD Toolkit, which is split into three sections that allow users to:
CTTI also reviewed other available resources, such as the QbD Principles document, a key tool for QbD implementation.
Jean Mulinde, a senior policy advisor for the FDA, then spoke about why quality is important to clinical trials.
“QbD should be implemented at the clinical trial level and may be one component of an organization’s overarching quality management system,” Mulinde said. “Implementing QbD serves to focus the protocol and all of the operational plans necessary to implement the protocol on critical processes and data from the outset of a trial.”
Representatives from both academic and private organizations also shared their successes in QbD implementation. Hamid Moradi, a faculty member and researcher at University of California-Irvine, said that his organization hosted a CTTI-led QbD workshop to increase buy-in, which received a positive response from attendees. Moradi also discussed the QbD working group established at UC Irvine.
“This team will be a resource to investigators to help them better design and conduct their trials using QbD principles,” he said.
Currently, CTTI is working on additional QbD resources to support implementation, which it aims to announce within the next year.