Quality by Design
CTTI Webinar Highlights the Importance & Benefits of Quality by Design
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:
- Learn about QbD;
- Introduce QbD to their organizations via workshops and printable resources; and
- Adopt QbD within their organizations.
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.
Four Key Areas Where CTTI Has Transformed Clinical Trials
This year, CTTI marks its 10th year of working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused. To commemorate this milestone, we will #CelebrateCTTI throughout the month of January. Join us for the celebration—visit this blog, follow us on Twitter, and register to attend our 10 Year Anniversary Symposium on Tues., Feb. 6.
Since its inception in 2007, CTTI has made transformational shifts in the design and conduct of clinical research. Let’s take a look at the evolution of clinical trials in four key areas, among many, in which CTTI has played a critical role in moving the industry toward more efficient, high-quality, and patient-centric trials:
Trial Quality
Regulators have long acknowledged a need to change how the industry approaches clinical trial quality in order to focus on reducing errors that undermine data integrity and patient safety. Drawing on the expertise of key stakeholders, CTTI issued recommendations on effective and efficient trial monitoring in 2012. The following year, FDA issued final guidance on a risk-based approach to monitoring, reflecting principles from CTTI’s work. CTTI also developed the concept of Quality by Design, taking the focus from a reactive approach using audits to a proactive approach that builds quality into clinical trials at the outset. CTTI released its Quality by Design recommendations and toolkit in 2015, and its work in this area has been cited in FDA guidance and incorporated into GCP guidelines.
Patient Engagement
CTTI has been a pioneer in patient engagement, involving patient representatives in its organizational leadership and throughout its project teams. Spurred by the FDA’s Safety and Innovation Act of 2012, CTTI initiated the Patient Groups & Clinical Trials Project to establish best practices for engaging patients in clinical research. In 2014, CTTI released landmark recommendations that are currently used by multiple stakeholders to facilitate productive relationships with patient groups around clinical trials. In 2017, CTTI and FDA announced a partnership on a new initiative, the Patient Engagement Collaborative, to improve patient engagement across the FDA.
Central IRB
Although U.S. regulators are enthusiastic about the use of a central IRB to promote more efficient multi-site clinical trials, enterprise-wide implementation has lagged. CTTI initiated the Central IRB Project in 2010, creating recommendations and resources to help organizations identify and address barriers to the adoption of a central IRB. The NIH issued a draft policy in 2014 referencing CTTI’s recommendations and a final policy in 2016 requiring all NIH-funded multi-site clinical trials to use a central IRB effective in 2018.
Real-World Evidence
Since its inception, CTTI has recognized that “real-world evidence” from electronic health records, mobile devices, and other sources can provide unique insights into important clinical questions and could improve the efficiency of clinical trials. The FDA Amendments Act of 2007, which mandated FDA to develop a system to link safety data from multiple sources, paved the way for the use of connected datasets in clinical trials. After partnering with the FDA and Harvard Pilgrim Health Care Institute to assess the feasibility of using the Sentinel database for clinical research, CTTI supported the first trial using Sentinel. CTTI also launched a program in 2016 to support the use of mobile technology in clinical trials, issued recommendations in 2017 on how to use registries as reusable platforms for trials, and announced a Real-World Evidence Project in 2017.
Upcoming Webinar: Quality by Design for Clinical Trials
On August 10, CTTI will present Clinical Trial Quality by Design: Factors Critical to Quality, a joint webinar with the Medical Device Innovation Consortium (MDIC). The presentation will feature strategies for designing quality, efficient clinical trials from CTTI’s Quality by Design (QbD) Project and MDIC’s Clinical Trial Design Working Group. MDIC was able to build upon CTTI’s QbD recommendations and address special considerations for the design of medical device clinical trials. This work demonstrates a strong synergy between two multi-stakeholder public-private partnerships dedicated to improving clinical trials.
We invite you to join this free, public webinar to learn more about quality design for clinical trials, including medical device trials.
CLICK HERE to register.
Topic: Clinical Trial Quality by Design: Factors Critical to Quality
Date & Time: Wednesday, August 10, 2016 at 1 p.m. ET
Speakers:
- Susan Alpert, MDIC Clinical Trial Design Working Group Chair
- Ann Meeker-O’Connell, CTTI QbD Project Team
New CTTI Publication Promotes Quality by Design Principles to Enhance Clinical Evidence
The growing cost and complexity of clinical trials is threatening the ability to generate new evidence to improve healthcare. CTTI’s latest publication, Enhancing Clinical Evidence by Proactively Building Quality Into Clinical Trials, from the Quality by Design (QbD) Project summarizes recommendations and tools for streamlining clinical. The QbD framework aims to promote critical thinking about trial design and oversight to reduce errors that matter while eliminating non-essential activities. By applying these principles, efforts can be focused on activities that are necessary for the reliability of trial findings and the protection of study participants.
The official QbD recommendations were released in 2015. In the recent publication, the authors describe the process for recommendation development in which stakeholders from across the clinical trial enterprise, including patient advocates, clinical investigators, regulatory reviewers, and trial sponsors, contributed perspectives through workshops and qualitative interviews.
The article was published in the journal Clinical Trials. To read the full publication, click here.
CTTI Presents on QbD at Data Quality & Technology In Clinical Trials Conference
On Tuesday, April 19, 2016, team leaders from CTTI’s Quality by Design (QbD) project, Ann Meeker-O’Connell and Mark Behm, will present at eyeforpharma’s Data Quality & Technology In Clinical Trials Conference.
This presentation, Examine the value proposition’s implication on trial design, will feature CTTI’s official Quality by Design Recommendations. These recommendations explore specific ways that quality can be built into the scientific and operational design and conduct of clinical trials.
We look forward to connecting with colleagues in the clinical trials enterprise at this event.