Quality By Design

NIH and FDA Release Clinical Trial Protocol Template

Posted on by Lorri Bingham

On March 17, 2016 the National Institutes of Health (NIH) together with the Food and Drug Administration (FDA) released for public comment a draft clinical trial protocol template for phase 2 and 3 Investigational New Drug application (IND) / Investigational Device Exemption (IDE) studies. Comments are being accepted until April 17, 2016. The goal of this effort is to allow investigators to more easily prepare protocols that are consistently organized with all the necessary information for review. The agencies welcome and encourage feedback from those involved in the clinical trial enterprise, including investigators, sponsors, members of institutional review boards, and other stakeholders, to help create a robust template for use with future protocols.

Efforts such as this template help to ensure consistency while streamlining protocol development and meeting regulatory requirements. CTTI is a proponent of an efficient, quality-driven, streamlined approach to the design, development, and conduct of clinical trials. Providing materials and resources to facilitate trial design and development is aligned with the CTTI Quality by Design (QbD) approach, and such tools can be easily integrated into clinical trial development plans. CTTI supports and applauds the NIH and FDA for their initiative and encourages similar work.

The draft template released by the NIH and FDA is available here. CTTI recommendations on how QbD principles can be applied to improve the quality and efficiency of clinical trials can be found here.

Recently Released: Expert Meeting Summary on Recruitment

Posted on by Lorri Bingham

On November 9 – 10, 2015, CTTI’s Recruitment Project Team hosted a multi-stakeholder, expert meeting to address the following objectives:

  • Present findings from the CTTI Recruitment Project’s evidence-gathering activities
  • Obtain stakeholder perspectives and critical feedback on draft considerations for more effective recruitment planning
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for moving recruitment planning upstream and achieving culture change
  • Identify implementation barriers to achieving change
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for overcoming barriers to achieving change

Maximizing recruitment efforts depends on the design and feasibility of the clinical trial protocol and site selection, as well as appropriate communication planning. Attendees discussed how to improve clinical trial recruitment efforts by incorporating Quality by Design (QbD) concepts into recruitment planning strategies, identifying and engaging important stakeholders, viewing recruitment through a patient-centric lens, and crafting and positioning the right messaging to encourage the public to inquire about recruitment opportunities. Experts presented and discussed current patient and public perceptions of clinical research and how this impacts trial recruitment. To improve recruitment overall, participants acknowledged that trust and better rapport among research scientists/medical professionals and patients/the public need to be fostered. Additionally, recruitment planning cannot rely on a one-size-fits-all approach; recruitment efforts must be fit for purpose and tailored to individual trials.

CTTI’s QbD Recommendations & Toolkit to be Featured in Upcoming NIH Collaboratory Grand Rounds

Posted on by Lorri Bingham

On August, 21, 2015, the recommendations and Toolkit resulting from CTTI’s Quality by Design Project will be featured in an NIH Collaboratory Grand Rounds webinar. QbD Team Leaders Ann Meeker-O’Connell of Johnson & Johnson and Mark Behm of AstraZeneca will be presenting.

“This toolkit represents a compilation of documents, guidelines, forms, and videos that will help you put Quality by Design into operation within your organization. It’s been developed by professionals from across the entire spectrum of the clinical trials endeavor.”
– Mark Behm, AstraZeneca

Webinar Details:

We encourage you to share this invitation with colleagues involved in the clinical trials enterprise.

#InnovationThroughCollaboration

New CTTI Webinar Available Online: An Introduction to QbD Recommendations & Toolkit

Posted on by Lorri Bingham

On July 16, 2015, the Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit. Released on June 15, 2015, this web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts. Whether you are first learning about QbD, want to disseminate these concepts within your organization, or are ready to implement QbD into your clinical trial, this Toolkit has resources for you.

A recording of this webinar is now available on the CTTI website.

Webinar Invitation: CTTI’s Recommendations & Toolkit for Implementing QbD in Clinical Trials

Posted on by Lorri Bingham

CTTI invites you to participate in a webinar hosted by the Quality by Design Project Team. During this webinar the project team will present the Quality by Design (QbD) recommendations and provide an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

Topic: Quality by Design Project: Recommendations and Toolkit

Date: Thursday, July 16th, 2015

Time: 12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)

Presenters:

  • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
  • Coleen Glessner, MBA, Quality Expert
  • Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford

To join:

  • Meeting Link: Click here
  • Meeting Number: 735 985 012
  • Meeting Password: ctti
  • After you connect to the website, please follow step-by-step instructions for connecting to the audio.

 

If you prefer to connect to audio only, you can join by phone at:

1-855-244-8681 Call-in toll-free number (US/Canada)

1-650-479-3207 Call-in toll number (US/Canada)

 

To view recordings of past CTTI QbD webinars, click here.

This webinar is open to the public. We encourage you to forward this invitation to others who may be interested in learning more about the QbD project’s recommendations and Toolkit.

What is Quality by Design?
Quality by Design (QbD) is an approach that focuses effort on those “errors that matter” for the success of the clinical trial. By prospectively examining the objectives of a trial and defining factors critical to meeting these objectives, action can be taken to prevent important risks to these critical factors from negatively impacting outcomes. Understanding what data and processes underpin a successful trial is essential to subsequently identifying and managing important and likely risks to improve quality and outcomes for clinical trials. For more information about QbD, click here.

#DIA2015 Wrap-Up: CTTI Conference Materials Available Online

Posted on by Lorri Bingham

The DIA’s 51st Annual Meeting earlier this month was a great success. In addition to presenting preliminary findings from several CTTI projects, we also unveiled the official recommendations and associated Toolkit from our Quality by Design (QbD) Project. We’d like to thank all of our colleagues who came together for a week of engaged discussion and learning.

We are now happy to share the materials from CTTI’s presentations. We hope you find them useful in your efforts to improve the quality and efficiency of clinical trials.

DIA SESSION: CLINICAL QUALITY BY DESIGN: FROM THEORY TO PRACTICE

DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS

 

DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE

 

DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS

 

DIA POSTER: RESULTS OF AN ONLINE SURVEY OF STAKEHOLDERS REGARDING BARRIERS AND SOLUTIONS TO CLINICAL TRIAL RECRUITMENT

  • CLICK HERE to view a PDF of this poster.
  • CLICK HERE for more information on CTTI’s Recruitment Project.

CTTI Releases New Recommendations & Toolkit to Help Organizations Implement Quality by Design

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) has issued recommendations to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not.

Recognizing that time and resources are finite, CTTI encourages sponsors to build quality into the scientific and operational design and conduct of a clinical trial. CTTI defines “quality” in clinical trials as the absence of errors that matter to decision making–that is, errors which have a meaningful impact on the safety of trial participants or reliability of the results (and thereby the care of future patients).

“CTTI’s recommendations put the patient perspective at the center of the process by proactively identifying and managing those aspects of clinical trials most likely to negatively impact trial participants. Patient advocates readily understand the need to focus on errors that matter rather than spreading effort and attention thinly across all potential errors,” said Nancy Roach, founder and chair of the board of Fight Colorectal Cancer.

CTTI recommends sponsors create a culture that values and rewards critical thinking and open dialogue about quality, and that goes beyond sole reliance on tools and checklists; focus effort on activities that are essential to the credibility of the study outcomes; involve the broad range of stakeholders in protocol development and discussions around study quality; and prospectively identify and periodically review the critical to quality factors.

A toolkit is available to help sponsors implement the recommendations. Included in the toolkit are resources that can facilitate proactive, cross-functional dialogue and decision-making about trial design and planning. For example, the Critical to Quality Factors document can help sponsors to focus on the critical to quality factors when designing clinical trial protocols. The critical to quality factors are not intended to be a simple check-list but to stimulate discussion and prioritization of the most critical determinants of a trial’s quality and formulation of an appropriate plan to define, avoid, mitigate, monitor and address important and likely risks to study quality.

“CTTI’s recommendations emphasize the importance of prospectively building quality into the scientific and operational design of clinical trials, rather than relying only on retrospective monitoring, inspection or scientific review. This systematic, proactive, and focused approach is compatible with FDA guidance on risk-based monitoring,” noted Robert Temple, M.D., Deputy Center Director for Clinical Science at the U.S. Food and Drug Administration (FDA).

The recommendations and toolkit have been formally unveiled during a presentation at the DIA annual meeting.

*For a link to a PDF of this press release, click here.

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 3)

Posted on by Lorri Bingham

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning, where quality is defined as the absence of errors that matter to decision-making. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, questions remain about the implementation of these principles.

To address these questions, CTTI’s QbD Project has organized a three-part webinar series, which explores concrete examples of real-world application of QbD Principles. The third and final webinar in this series recently took place on April 15, 2015, featuring speakers from Johnson & Johnson and the University of Oxford who discussed how QbD has been executed within their organizations, as well as the lessons gleaned from their experiences.

We’re happy to share the recording of this webinar, and we encourage you to share it with your colleagues.

To view a recording of the first webinar in this series, click here.

To view a recording of the second webinar in this series, click here.

Mark your calendars for 12:00 PM EST on July 16, 2015! CTTI will be hosting a public QbD webinar to unveil our QbD toolkit. The QbD Toolkit will provide users with resources for:

  1. Promoting QbD concepts in their organization,
  2. Educating colleagues about QbD concepts via case studies, and
  3. Implementing QbD in real trials.

From Theory to Practice: Advancing QbD in Clinical Trials at Upcoming Partnerships in Clinical Trials Conference

Posted on by Lorri Bingham

Quality by Design (QbD) emphasizes building quality into a process from the beginning. While a broad cross-section of key stakeholders in the clinical trials enterprise agree that the widespread adoption of an enlightened QbD approach to trial planning, conduct, and oversight is needed to ensure trial quality and efficiency, a lack of real-world examples of this process leave many wondering how to move from theory to practice.

To help answer these questions, two members of CTTI’s QbD Project will be presenting at the 24th Annual Partnerships in Clinical Trials Meeting in Boston, MA on April 24, 2015:

Session Title: Clinical Quality by Design – Principles to Practice

Speakers:

  • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, BioResearch Quality and Compliance, Johnson & Johnson Quality and Compliance
  • Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer

Agenda:

  • Develop understanding of Quality by Design (QbD) principles for clinical trials
  • Identify perceived barriers and potential solutions to the adoption of Quality by Design
  • Review opportunities for dissemination of these principles and practices to a broad array of stakeholders

We look forward to connecting with our colleagues at #PCTUS.

If you are interested in hearing more stories of translating QbD principles into practice, please join us during a one-hour CTTI-hosted webinar on April 15.