Ensuring Quality

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.

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.

Participate in CTTI’s Survey on Data Monitoring Committees

Posted on by Lorri Bingham

We are inviting participants to a survey from the Clinical Trials Transformation Initiative (CTTI) to gather information about the current use and conduct of Data Monitoring Committees (DMCs). We aim to gain a deeper understanding of the purpose and rationale for using DMCs, goals and responsibilities of DMCs and current conduct and communications between stakeholders using this survey and future focus groups. Your input is critical as the survey results will be considered in developing recommendations on best practices for DMC use and conduct.

WHO IS BEING ASKED TO PARTICIPATE
Current and former DMC members; and representatives of research sponsors (government, industry and academic), clinical and academic research organizations (CROs/AROs) and statistical analysis centers who directly interact with DMCs. We encourage you to forward this email to qualified colleagues.

WHAT WE ARE ASKING OF YOU
You will be asked to complete one brief, electronic survey that should take less than 15 minutes to complete. The survey is anonymous; no unique identifier will link you to your responses. In this format, please note that it is therefore necessary that you finish the survey completely before exiting out of your web browser, as the survey will not save partial responses.

PLEASE CLICK ON THIS LINK TO COMPLETE THE ANONYMOUS SURVEY.

YOUR ANSWERS WILL BE TREATED CONFIDENTIALLY
We will not be able to link your personal information such as email address and name with your answers. Your answers will be combined with those from others, and we will report answers only in aggregate.

HOW YOUR INPUT WILL BE USED
The study results will be used by CTTI to develop additional investigational activities, such as focus groups and an expert meeting. Evidence gathered from these activities will support recommendations on best practices for DMC use and conduct, to be published and used to develop toolkits for the various stakeholder groups. For more information, go to https://ctti-clinicaltrials.org/our-work/ethics-and-human-research-protection/data-monitoring-committees/.

WHO WE ARE
CTTI is a public-private partnership, established by the US Food and Drug Administration (FDA) and Duke University, whose membership includes representatives from academic institutions, clinical research organizations, institutional review boards, patient groups, pharmaceutical, biological and device companies, professional societies, US government and other stakeholders within the clinical trials enterprise. CTTI conducts projects in support of its mission to identify and promote practices that will increase the quality and efficiency of clinical trials.

WHO TO CONTACT FOR QUESTIONS
You should direct any questions or concerns regarding your survey participation to CTTI (ctti-dmcproject@duke.edu). For questions or concerns about your rights as a research subject, you can also contact the Duke Institutional Review Board (IRB) at 919-668-5111.

Thank you for your consideration,

The Clinical Trials Transformation Initiative Data Monitoring Committee Project Team Leaders:

Patrick Archdeacon
U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Raymond Bain
Merck Research Laboratories

Karim Calis
U.S. Food and Drug Administration, Center for Drug Evaluation and Research

David DeMets
University of Wisconsin-Madison

Jane Perlmutter
Patient Representative

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)

CTTI Tackles 3 Issues in Clinical Trials with New Projects

Posted on by Lorri Bingham

At CTTI, we are continuously looking for practices that will increase the quality and efficiency of clinical trials. In 2014, three new topics have been added to our portfolio:

  1. Conducting Trials Using Data Registries: Demographic, disease, and outcome data collected in clinical observational registries often overlap with data gathered for clinical trials. Integrating clinical trials within observational data registries may offer opportunities to avoid duplicative data collection and increase efficiency while decreasing clinical trial costs. Objectives for this project include identifying upfront costs and operational adjustments required to utilize a data registry for a clinical trial, as well as recommending best practices for conducting randomized registry trials.
  2. Data Monitoring Committees (DMCs): As the use of DMCs has increased and evolved over the past 40 years, critical issues have emerged. A few of these issues include differences in DMC roles and responsibilities, which contributes to confusion and unclear expectations, as well as a lack of a clear plan for preparing the next generation of DMC members. Objectives for this project include understanding the current landscape of DMC use and conduct, clarifying the purpose of and rationale for using a DMC, and describing effective communication practices between independent DMCs and other trial stakeholders.
  3. Investigator Turnover: While an enormous amount of time and resources are spent initiating new investigators into the clinical trial process, there continues to be a high turnover rate for investigators. As many as 40% of investigators annually choose not to participate in another FDA-regulated trial. This high rate of attrition impacts site and overall trial performance. Objectives for this project include obtaining a more thorough understanding of the factors that influence investigators’ decisions to leave the clinical research practice, as well as defining the impact of investigator turnover on industry and society.

 

New Publication Addresses Rising Antibiotic Resistance and Clinical Trial Design

Posted on by Lorri Bingham

On June 23, 2014, an article titled Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance was published online in Statistics in Medicine. This article describes a novel clinical trial model to determine efficacy of antibacterial drugs in trial populations with emerging antibiotic-resistant bacterial infections.

Authors Mohammad Hugue and colleagues cite the CTTI-hosted Statistical Issues Think Tank where they and other experts were able to exchange ideas that in part lead to the development of the model.

For more information on this meeting, including the list of attendees, agenda, presentations, and background summary, CLICK HERE.

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.