Quality By Design Archives - Page 6 of 10

CTTI Webinar Highlights the Importance & Benefits of Quality by Design

Posted on May 20, 2019March 7, 2025 by Lorri Bingham

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.

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

Posted on January 25, 2019March 7, 2025 by Lorri Bingham

CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.

“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as significant benefits and barriers. Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.

“Further, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design. Engaging these groups early and often is the key to running better trials.”

CTTI conducted surveys and in-depth interviews to better understand the perceptions of patients and clinical investigators, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

The resulting recommendations are designed to assist research sponsors in:

Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection, and pilot testing
Maximizing value and minimizing burden for study participants, including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support
Addressing challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for planning and conducting decentralized clinical trials.

The free webinar will begin at noon ET and will be led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

CTTI Shares Latest Findings on Mobile Technology, Patient Engagement, and More at DIA 2018

Posted on June 11, 2018March 6, 2023 by Lorri Bingham

At this year’s DIA 2018 Global Annual Meeting, CTTI will share insights across a broad range of topics that are core to its mission of enhancing the quality and efficiency of clinical trials. During the event, which will take place in Boston from June 24-28, CTTI will take part in 10 different presentations and sessions in areas ranging from patient-focused medical development to the use of mobile technology for data capture to quality approaches to clinical trial design.

Please join us at the CTTI exhibitor booth (#1624) and attend our presentations:

Presentation: The Metamorphasis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:00 p.m.
Presenters: Angela Botto-van Bemden (Arthritis Foundation)
Related CTTI Project: MCT Stakeholder Perceptions

Presentation: Patient-Focused Medicines Development: Where It Has Led Us Today, What Challenges Remain and What Do We Still Need to Do to Achieve Success?
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.
Presenter: Pamela Tenaerts (CTTI)

Related CTTI Projects: Patient Groups & Clinical Trials

Presentation: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.

Chair: Robert DiCicco (TransCelerate Biopharma)
Presenters: Philip Coran (Medidata Solutions), Cindy Geoghegan (Individual Patient/Caregiver), and Jan Hewett (FDA/CDER)
Related CTTI Project: MCT Mobile Technologies

Engage & Exchange Session: New Approaches, Novel Endpoints, and Next-Generation Trials
Date & Time: Mon., June 25, 1:45 – 2:45 p.m.

Chair: Jennifer Goldsack (CTTI)
Facilitators: Jessie Bakker (Philips Respironics), Daniel Karlin (Pfizer), and Komathi Stem (monARC Bionetworks)

Related CTTI Project: MCT Novel Endpoints

Presentation: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Date & Time: Mon., June 25, 3:00 – 4:15 p.m.

Chair: Annemarie Forrest (CTTI)
Presenters: Sabrina Comic-Savic (The Medicines Company) and Julie Dietrich (Amgen)
Related CTTI Project: Quality by Design

Content Hub: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
Date & Time: Tues., June 26, 1:30 – 2:00 p.m.
Presenter: Jennifer Goldsack (CTTI)
Related CTTI Project: MCT Mobile Technologies

Presentation: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.

Chair: Jane Myles (Genentech – a member of the Roche group)
Presenters: Gerrit Hamre (CTTI), Leonard Sacks (FDA/CDER), and Komathi Stem (monARC Bionetworks)
Related CTTI Project: MCT Mobile Technologies, MCT Novel Endpoints

Presentation: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Sunil Agarwal (HCL America) and James Streeter (Oracle)
Related CTTI Project: MCT Data Collection

Presentation: Redefining the Site Investigator’s Experience

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Kaitlin Malone (Amgen)

Related CTTI Project: Investigator Community

Presentation: Data and Quality Approaches to Informing Global Investigative Site Selection

Date & Time: Wed., June 27, 8:00 – 9:15 a.m.

Chair: Stella Stergiopoulos (Tufts Center for the Study of Drug Development)
Presenter: James Kremidas (ACRP)
Related CTTI Project: Investigator Qualification

Poster: Effective Engagement Between Sponsors & Patient Groups: A Structured Process and Use Cases from CTTI

Date & Time: Wed., June 27, 9:30 – 10:30 a.m., 12:00 – 2:00 p.m., 3:00 – 4:00 p.m.

Presenter: Zach Hallinan (CTTI)

Related CTTI Project: Patient Groups & Clinical Trials

Now Available: CTTI Symposium Presentations

Posted on February 13, 2018July 9, 2021 by Lorri Bingham

For those unable to attend the CTTI 10-year Symposium on Feb. 6, we are pleased to share slides from each of the exciting, informative sessions:

Meeting Presentations

Welcome and Introduction to CTTI by Pamela Tenaerts, CTTI
Welcome from the Executive Committee by Jacqueline Corrigan-Curay, FDA, CDER
Keynote Address by Robert Califf, Duke University / Verily
Reflection on Quality by Design by Robert Temple, FDA, CDER
Quality by Design Project Overview and Recommendations by Ann Meeker-O’Connell, Johnson & Johnson
Quality by Design Case Study by Julie Dietrich, Amgen, Inc
PGCT Project Overview and Recommendations by Bray Patrick-Lake, Duke Clinical Research Institute
PGCT Case Study by Ron Bartek, Friedreich’s Ataxia Research Alliance
PGCT Case Study by Jeff Sherman, Horizon Pharma
Single IRB of Record Project Overview and Recommendations by Soo Bang, Celegene
Single IRB of Record Case Study by Hallie Kassan, Feinstein Institute for Medical Research, Northwell Health

Thank you again to all of our esteemed presenters who made the CTTI Symposium a great success! Keep an eye on this blog for a complete recap of the event later this week.

Four Key Areas Where CTTI Has Transformed Clinical Trials

Posted on January 8, 2018March 10, 2025 by Lorri Bingham

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

Posted on August 8, 2016March 10, 2025 by Lorri Bingham

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

Posted on May 18, 2016March 10, 2025 by Lorri Bingham

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

Posted on April 18, 2016March 10, 2025 by Lorri Bingham

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.