Webinars

Quality by Design Project: Recommendations and Toolkit

CTTI Project: Quality by Design

Webinar 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

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

The Quality by Design (QbD) project team presented the QbD recommendations and 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.

Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

CTTI Project: Patient Group Engagement

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Webinar Presenters

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

Presenting CTTI Recommendations: Informed Consent

CTTI Project: Informed Conent

Webinar Presenters:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

Results of National Public Poll on Clinical Trials

Webinar Presenters:

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

A few months ago, CTTI assisted with questions to include in a national poll conducted by Research!America, the nation's largest not-for-profit, membership-supported, grassroots public education and advocacy organization. They are committed to making medical and health research a higher national priority, and Woolley's review of the survey includes trust factors for clinical trial participation, as well as attitudes towards and information sources for clinical trials.

Sponsors’ Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

CTTI Project: Single IRB

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Webinar Presenters:

  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
  • Soo Bang, Sr. Director, Business Development & Global Alliances, Celgene Corporation
  • Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

To share experiences across different sponsor organizations in implementation of central IRB model for multi-centered clinical trials

Webinar Agenda

  1. Introduction: CTTI Use of Central IRBs for Multi-center Clinical Trials Project and Recommendations
  2. Sponsors’ role in choosing to use a central IRB for multi-center clinical trials
  3. One biopharmaceutical sponsor’s approach for adapting to new paradigm for IRB review in the U.S.
  4. A federal sponsor's experience of using a single central IRB for clinical trial networks
  5. Questions and Discussion