Formats
Webinar Invitation: CTTI’s Recommendations & Toolkit for Implementing QbD in Clinical Trials
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.
CTTI’s IND Safety Advancement Project Presents at 7th Annual AACI Conference
On July 8-9, 2015, the Association of American Cancer Institutes (AACI) will host their 7th Annual AACI Clinical Research Initiative Meeting in Chicago. The results of CTTI’s IND Safety Advancement Project survey and interviews will be featured in the session titled, How Do Cancer Centers Ensure Patient Safety when Conducting Clinical Trials? The goal of this CTTI project is to increase compliance with respect to assessment, communication, review, and management of expedited IND safety reports. We look forward to this opportunity to share our work with colleagues.
Are you interested in safety reporting in clinical trials? Click here to read CTTI’s recommendations that resulted from our original IND Safety Project.
#DIA2015 Wrap-Up: CTTI Conference Materials Available Online
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
- Clinical Quality-by-Design (QbD): Principles to Practice by Coleen Glessner, Pfizer, Inc.
- Clinical Quality By Design: FDA Point of View by Jean Mulinde, CDER, FDA
- CLICK HERE for more information on CTTI’s Quality by Design Project.
DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS
- Introduction to the CTTI Data Monitoring Committees Project by Karim Calis, CDER/FDA and NICHD/NIH
- The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps by Susan Ellenberg, University of Pennsylvania
- CTTI DMC Project Survey and Focus Group Findings: Communication Practices by Ray Bain, Merck Research Laboratories
- DMC Qualification, Composition and Training by Jane Perlmutter, Patient Advocate
- CLICK HERE for more information on CTTI’s Data Monitoring Committee Project.
DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE
- The Clinical Trials Transformation Initiative IND Safety Advancement Project: Findings and Next Steps by Michael Jones, Eli Lilly & Company
- CLICK HERE for more information on CTTI’s IND Safety Advancement Project.
DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS
- CTTI Patient Groups and Clinical Trials: Building the Value Model by Matthew Harker, CTTI
- Progress Through Partnership: Actively Engaging Patient Groups in the Clinical Research Process by Petra Kaufmann, NCATS/NIH
- CTTI Patient Groups and Clinical Trials Industry Measurements by David P. Leventhal, Pfizer, Inc.
- CLICK HERE for more information on CTTI’s Patient Groups & Clinical Trials Project.
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.
NIH Collaboratory Grand Rounds to Feature CTTI’s Central IRB Recommendations
On July 10, 2015, the NIH Collaboratory’s Grand Rounds Webinar Series will feature the work of CTTI’s Central IRB Advancement Project. Co-team leader Cynthia Hahn will review the recently released recommendations for advancing the use of central IRBs for multicenter clinical trials. We look forward to this opportunity to connect with colleagues and share the results of this project. Please forward this invitation with others interested in clinical triahttps://ctti-clinicaltrials.org/our-work/ethics-andl conduct.
Topic: The Clinical Trials Transformation Initiative’s (CTTI) Recommendations: Advancing the use of central IRBs for multicenter clinical trials
Date: Friday, July 10, 2015
Time: 1:00-2:00 p.m. ET
Speaker: Cynthia Hahn, Vice President, Clinical Research & Regulatory Affairs at North Shore-LIJ Health System, Chief Operating Officer, The Feinstein Institute for Medical Research
Meeting Link:
https://dukemed.webex.com/dukemed/j.php?MTID=m1a4a0665a615ae0382440edecedbdd33
For Audio ONLY:
Call-in toll-free number (US/Canada): 1-855-244-8681
Access code: 739 348 059
For additional webinar details, visit the NIH Collaboratory’s Grand Rounds calendar.
This is the first part of a webinar series co-hosted by the NIH Collaboratory and PCORnet, titled “A Grand Rounds Special Series: Use of Central IRBs for Multicenter Research.”
CTTI Receives 2015 DIA Regional Inspire Award for the Americas at the DIA 2015 51st Annual Meeting
On Sunday evening, CTTI proudly accepted the 2015 DIA Outstanding Contribution to Health Award for the Americas. This award recognizes organizations that have made significant innovative contributions to advancing health in the region.
“We’re honored to receive this award. It is a testament to CTTI’s dedicated membership and staff, who come together as equal partners to develop evidence-based solutions that improve the clinical trials process,” said CTTI’s executive director Pamela Tenaerts. “CTTI’s recommendations and implementation tools are having a true impact as demonstrated by changes in the clinical trial enterprise and by this award.”
“CTTI’s unique model that involves all stakeholders in the clinical trial process as equal partners to identify solutions is one that should be replicated across the industry. The procedures and tools the organization has developed are streamlining and refining the process of conducting trials, ushering in a new gold standard in research development and leading to stronger evidence-based prevention and treatment options.”
– Susan Cantrell, senior vice president and managing director, DIA Americas (Source: prweb.com)
We look forward to the remainder of the week at #DIA2015. CTTI will be presenting preliminary findings from a number of projects, as well as unveiling the latest recommendations and tools to improve quality and efficiency in clinical trials. For more information on CTTI’s presentations at this conference, click here.
Photo: CTTI’s emeritus executive committee member Ken Getz, executive director Pamela Tenaerts, and steering committee member Jeff Sherman at the DIA Award Dinner on June 14, 2015.
CTTI Releases New Recommendations & Toolkit to Help Organizations Implement Quality by Design
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.
CTTI to Unveil Official Recommendations & Preliminary Project Findings at #DIA2015
CTTI will unveil official recommendations of the Quality by Design (QbD) Project at the DIA’s 51st Annual Meeting in Washington, DC. Quality by Design is an approach to clinical development that prospectively examines the objectives of a clinical trial and defines factors critical to meeting those objectives. These recommendations and an associated toolkit will assist organizations to implement QbD principles within their trials.
Additionally, at this conference, CTTI will share preliminary findings from projects on data monitoring committees, IND safety reporting, recruitment, and patient group engagement. As always, we look forward to connecting with our colleagues at this event. See below for details regarding CTTI’s presence at #DIA2015:
Session: Clinical Quality by Design: From Theory to Practice
Date: June 15, 2015 from 11:00 AM – 12:30 PM
Presenters: Ann Meeker-O’Connell, Chair (Janssen), Coleen Glessner (Pfizer), Jean Mulinde (CDER/FDA), James Streeter (Oracle Health Sciences)
Session: The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps
Date: June 15, 2015 from 11:00 AM – 12:30 PM
Presenters: Susan Ellenberg, Chair (University of Pennsylvania), Ray Bain (Merck), Karim Calis (FDA), Jane Perlmutter (Patient Representative)
Session: Translating New Knowledge from Regulatory Science into Postmarketing Safety Practice
Date: June 16, 2015 from 3:30 PM – 5:00 PM
Presenters: Gerald Dal Pan, Chair (FDA), Michael Jones (Eli Lilly), Darrell Abernethy (FDA), Peter Richard Arlett (EMA)
Session: Best Practices for Effective Engagement with Patient Groups Around Clinical Trials
Date: June 17 from 3:30 PM – 5:00 PM
Presenters: Bray Patrick-Lake, Chair (CTTI), Wendy Selig (WSCollaborative), Matthew Harker (CTTI), David Leventhal (Pfizer)
Poster: Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruitment
Date: June 16 & 17 from 9:00 AM – 4:00 PM
Presenters: Jamie Roberts (CTTI), Elizabeth Mahon (Janssen)
For a complete list of CTTI’s upcoming events, please click here.
New CTTI Webinar Available Online: MIT Collaborative Initiatives’ Clinical Trials Systems Project
On May 21, 2015, CTTI hosted a webinar spotlighting the MIT Collaborative Initiatives’ Clinical Trials Systems Project. The mission of this initiative is to promote a systems-based approach to solving deep-rooted societal issues by engaging experts from a broad range of disciplines both within and outside the scope of a problem. Their Clinical Trials System Project is now applying this approach to the pharmaceutical clinical trial process with the goal of improving the efficiency and effectiveness of the trial process to reduce cost and improve access for patients.
During this webinar, Tenley Albright, Tak Igusa, and Enrique Martinez gave an introduction to the Clinical Trials Systems Project. A great deal of synergy exists between CTTI and this project, and we look forward to complementing each other’s work with in solving critical issues in the clinical trials enterprise. A recording of this webinar is now available on the CTTI website.
“We have yet to speak with anyone who thinks the U.S. clinical trials system should remain as it is now.”
-Dr. Tenley Albright, Strategic Lead, The Clinical Trials Systems Project
#InnovationThroughCollaboration