Quality By Design

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 2)

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. 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 second webinar in this series recently took place on January 14, 2015 and featured speakers from The Medicines Company and AstraZeneca 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. The final webinar in this series is scheduled for Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST.

CTTI Webinar Provides Real-World Examples of Quality by Design (QbD) in Clinical Trials (Part 2)

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar hosted by the Quality by Design (QbD) Project team. QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the second in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. (Click here to view the first webinar in this series.)

Topic: Translating Quality by Design Principles into Practice, Part 2

Date: Wednesday, January 14, 2015

Time: 11:00 a.m. – 12:00 p.m. Eastern Standard Time (New York, GMT-05:00)

Agenda:

  • CTTI QbD Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical QA Strategy, Janssen
  • Quality Management in Clinical Trials: Keeping it Simple by Sabrina Comic-Savic, MD, MPH Senior Director, GCP Compliance, The Medicines Company
  • QbD – An Example from a Running CV Outcome Trial by Helene DuPui-Ekdal Director, Clinical Development, AstraZeneca
  • Q & A

THIS WEBINAR IS OPEN TO THE PUBLIC. WE ENCOURAGE YOU TO FORWARD THIS INVITATION TO OTHERS WHO MAY BE INTERESTED IN LEARNING MORE ABOUT QBD IMPLEMENTATION.

To join the webinar on January 14, go to:
https://dukemed.webex.com/dukemed/j.php?MTID=m6674f0b144ed076e5afb9322a67442d9
Meeting Number: 738 965 414
Meeting Password: ctti

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)

The playback of UCF (Universal Communications Format) rich media files requires appropriate players. To view this type of rich media files in the meeting, please check whether you have the players installed on your computer by going to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

Mark your calendars. The QbD Webinar Series will continue on the following date:

Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)

CTTI’s Tools for Improving Clinical Trial Quality & Efficiency

Posted on by Lorri Bingham

In our pursuit to enhance the implementation of CTTI’s recommendations, we’ve created a new webpage on our site that we’d like to share with you. This page features CTTI’s three most commonly used tools:

  1. The Considerations Document for a Single IRB of Record: Developed by CTTI’s Central IRB Project, this tool supports communication and contractual relationships between institutions and a central IRB to address blurred distinctions between responsibilities for ethics review and other institutional obligations. Primary users for this tool include sponsors, academic institutions, investigators, IRBs that act as a single IRB of record.
  2. The Quality by Design Principles Document: Developed by CTTI’s QbD Project, this tool helps those working in trials to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality. Primary users for this tool include anyone interested in designing and conducting clinical trials.
  3. The AACT Database: Developed by CTTI’s State of Clinical Trials Project, this tool makes the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Primary users for this tool include researchers interested in analyzing data from clinical trials.

The Tools Page can be accessed on the CTTI site under Briefing Room > Tools. We hope that you find this resource valuable and share with your colleagues in the clinical trials enterprise.

CTTI Among the Spotlighted Consortia Focused on Drug Development Challenges

Posted on by Lorri Bingham

The latest issue of Nature Reviews Drug Discovery highlights several consortia that have resulted from the FDA’s Critical Path Initiative, launched nearly a decade ago. CTTI is among these initiatives and was featured in the article, The Clinical Trials Transformation Initiative: innovation through collaboration.

This publication explains the crisis in the clinical trials enterprise and CTTI’s unique role in developing actionable solutions. Several CTTI project are highlighted, including Quality by Design, Central IRB, and Investigational New Drug Safety Reporting. For each of these projects, the authors identify the issue at hand and go on to explain CTTI’s efforts to implement recommendations, noting both the difficulties and imperative of creating cultural and organizational change. The authors also comment on the ability of CTTI’s evidence-based work to inform policy and practices in the interest of public health.

“By creating an environment of trust, we enable the stakeholders — representing all sectors of the enterprise — to think about practical solutions to the identified problems and to develop strategies to effect change.”
– Pamela Tenaerts, Leanne Madre, Patrick Archdeacon, and Robert Califf

Operationalizing QbD in Clinical Trials: Lessons from Industry

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. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, you may be wondering how these principles translate into practice.

On October 16, CTTI hosted a webinar featuring speakers from Pfizer and Seattle Genetics 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 continue the exploration of real-world applications of QbD principles in clinical trials, two additional webinars have been scheduled. Please mark your calendars for these dates:

  • Wednesday, January 14, 2015, 11:00 a.m. – 12:00 p.m. EST
  • Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST

If you would like to be added to our QbD webinar e-mailing list, contact Kimberley Smith (kimberley.i.smith@dm.duke.edu) to receive reminders of the upcoming webinars, as well as notifications of the recordings.

CTTI-Hosted Webinar Provides Real-World Examples of Quality by Design (QbD) in Clinical Trials

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar hosted by the Quality by Design (QbD) Project team. QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials.

Topic: Translating Quality by Design Principles into Practice

Date: Thursday, October 16, 2014

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

Agenda:

  • CTTI Quality by Design Project Overview – Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
  • Pfizer Experience – Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
  • Seattle Genetics Experience – Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
  • Q & A

This webinar is open to the public.

We encourage you to forward this invitation to others who may be interested in learning more about QbD implementation.

 

To join the webinar on October 16, go to:

https://dukemed.webex.com/dukemed/j.php?MTID=m27634ad504de56e6e23456b195047753

Meeting Number: 731 417 196

Meeting Password: ctti

For those wishing to access the audio conference only, please dial 1-855-244-8681(access code: 731 417 196).

The playback of UCF (Universal Communications Format) rich media files requires appropriate players. To view this type of rich media files in the meeting, please check whether you have the players installed on your computer by going to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

Mark your calendars. The QbD Webinar Series will continue on the following dates:

  • Wednesday, January 14, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)
  • Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)

Invent the Future with CTTI at DIA 2014 50th Annual Meeting

Posted on by Lorri Bingham

On June 15-19, the DIA is hosting their 50th Annual Meeting in San Diego, CA. The tagline for this year’s event, Celebrate the Past – Invent the Future, resonates closely with one of CTTI’s own strategic approaches: helping to shape the clinical trials enterprise of the future.

During this week of forward-thinking discussions, we look forward to connecting with many of you. Several CTTI representatives will be presenting, and CTTI will also host a pre-conference tutorial. Specifically, we look forward to sharing our work on quality by design, patient recruitment, antibacterial drug development, and good clinical practice. Below is a schedule of opportunities to hear more about these topics at the conference.

Sunday June 15, 2014

9:00 AM – 5:00 PM – Quality by Design, from Theory to Practice

  • Event Information: Pre-Conference Tutorial TUT44 (*Advanced Registration Required)
  • Presenters: Ann Meeker-O’Connell, Jean Mulinde, John Alexander
Tuesday June 17, 2014

7:15 AM – 4:00 PM – A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols

  • Event Information: Poster – W30 located in the Sails Pavilion
  • Presenter: Charles Knirsch

8:00 AM – 9:30 AM – Updated Strategies for Effective Recruitment of Patients in Clinical Trials

  • Event Information: Panelist Session #201 located in Room 1B
  • Presenters: Elizabeth Mahon (Chairperson); Margo Michaels, Jonca Bull (Panelists)

1:30 PM – 3:00 PM – Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn’t)

  • Event Information: Panelist Session #259 located in Room 2
  • Presenters: Douglas Peddicord (Chairperson); Dalvir Gill, Christine Pierre, Pamela Tenaerts, Ann Meeker-O’Connell (Panelists)
Wednesday June 18, 2014

7:15 AM – 4:00 PM – Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

  • Event Information: Poster – T03 located in the Sails Pavilion
  • Presenter: Jonathan Seltzer

If you are on Twitter, please feel free to connect with us on that platform, too:

CTTI Tackles Practical Applications of Quality by Design at the DIA’s 50th Annual Meeting

Posted on by Lorri Bingham

DIA Meeting

This summer, the DIA will host their 50th Annual Meeting in San Diego, CA, bringing together “a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.” We are proud to announce that CTTI will be hosting a one-day, pre-conference tutorial, titled Quality by Design: From Theory to Practice, in conjunction with this event. This Quality by Design (QbD) tutorial is intended to give representatives from a broad cross-section of the clinical trials enterprise practical insights into applying QbD principles into their work. Emphasis will be placed on:

  • Developing an understanding of risk-based QbD for clinical trials, from general principles, real-world examples, and hypothetical case studies;
  • Gaining confidence in the application of building quality into the clinical trials process;
  • And identifying perceived barriers to the adoption of Quality by Design principles.

The QbD tutorial will be held on Sunday June 15, 2014, from 9 am – 5 pm, and will be co-instructed by Ann Meeker-O’Connell (Janssen), John Alexander (Duke), and Jean Mulinde (FDA/CDER). This pre-conference tutorial is open to any individual registered for the DIA conference. (To register for the DIA conference, CLICK HERE.)

*Note: There is limited availability for the pre-conference tutorial. To assure your seat, please sign up as soon as possible.

To view more information on CTTI’s ongoing QbD project, CLICK HERE.

Materials Available for Device-Focused Workshop in QbD Project

Posted on by Lorri Bingham

On January 29-30, 2014, CTTI’s QbD Project held a workshop focused on clinical trials that evaluate medical devices (diagnostic and therapeutic). The objectives for this workshop were similar to previous QbD Workshops:

  • To develop understanding of risk-based Quality by Design (QbD) for clinical trials, from general principles, real-world examples, and hypothetical case studies;
  • Gain confidence in the application of such concepts to clinical trials;
  • Identify obstacles to the adoption of this approach;
  • And identify opportunities for dissemination of these principles and practices to a broad array of stakeholders.

 

Patient Perspective: Why We Need Reform of the Clinical Trial Process

Posted on by Lorri Bingham

“Duchenne muscular dystrophy (DMD) is a, rare, progressive and ultimately fatal pediatric genetic disease that affects male children. Parents usually learn that their seemingly healthy son has DMD at age 4 to 5. By age 9 to 10, afflicted boys typically lose the ability to walk, eat and care for themselves, eventually becoming reliant on a ventilator. These patients commonly die in their 20s of respiratory complications or cardiomyopathy. There are currently no effective treatments.

Fortunately, there are very promising clinical candidates entering phase II and III trials. The problem is that the only validated endpoint for DMD drug approval is the Six Minute Walk Test, a measure that is most sensitive at a time when the boys are still ambulatory but beginning to lose the ability to walk. Furthermore, any time spent in the placebo arm of a trial for an effective treatment represents a lost opportunity for those participants. Some boys in the placebo arm may plateau at a much lower functional level after they are crossed over to the drug, or they may lose the ability to walk altogether. This loss of ambulation can mean that the patient is no longer eligible for future trials, and can lead to a loss of hope for the family involved.

We need to think about creative trial designs to minimize the amount of time spent in the placebo treatment, as well as different endpoints with faster, more efficient ways to validate them.”

– Sharon Hesterlee, PhD, VP Research, Parent Project Muscular Dystrophy

This piece was featured in CTTI’s 2013 Annual Report. To view this document, CLICK HERE.