Formats

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

Research Institution 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

  • Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System

*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 from two research institutions about implementation of a central IRB model for multi-center clinical trials

Webinar Agenda

  1. Results from a randomized, controlled trial of central versus local IRB review
  2. The institutional policy resulting from study results and a summary of conclusions that can be applied more broadly
  3. The continuing role of the institution in research compliance
  4. Examples from a research institution that serves as a central IRB and relies on commercial, academic, and federal external IRBs for multi-center clinical trials
  5. Questions and Discussion

Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database

CTTI Project: Electronic Healthcare Data

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Webinar Presenters:

  • Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
  • Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University

Webinar Objective:

This webinar provides an update on the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.

Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This webinar discusses the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.

IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.

Patient Advocacy/Industry Partnerships to Accelerate Therapy Development

CTTI Project: Patient Group Engagement

Webinar Presenters:

  • Sharon Hesterlee, Ph.D., Vice President Research, Parent Project Muscular Dystrophy
  • Holly Peay, MS CGC, Vice President, Education and Outreach, Parent Project Muscular Dystrophy, and Director, DuchenneConnect Registry

*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

Sharon Hesterlee and Holly Peay discuss the ways in which Parent Project Muscular Dystrophy (PPMD) has partnered with industry to accelerate therapy development for Duchenne Muscular Dystrophy.

Webinar Resources:

Preliminary Evidence from Sponsors & Investigators Using Mobile Devices

CTTI Project: Digital Health Trials

Webinar Presenters:

Project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips)

Webinar Objective:

In this webinar, project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips) provide an update on CTTI’s Mobile Devices Project, which focuses on scientific and technological challenges affecting the selection and use of mobile technologies in clinical research. The presenters share preliminary evidence gathered from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. Issues addressed in the webinar include:

  • Challenges affecting data management, validation, analysis, and security in mobile technologies;
  • Scientific and technical considerations in mobile device selection; and
  • Approaches to managing and reporting safety signals and adverse events.

Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (FDORA)

OCTOBER 18 & 19, 2023

Virtual Public Meeting Resources:

Final Meeting Report and Summary

Full two-day agenda

Download full two-day PowerPoint slide set

Speaker and Panelist Biographies

Guidances and Additional Resources

Virtual Public Meeting Recordings:

Watch Day 1:

 

Watch Day 2:

*ASL interpretation and Closed Captioning (CC) is available on both videos.

Virtual Public Meeting Speakers, Moderators & Panelists:

Day 1 (in order of appearance):

  • Jacqueline Corrigan-Curay, Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
  • Janet Woodcock, Principal Deputy Commissioner, FDA
  • John Farley , CDER, FDA
  • Anina Adelfio, Chief Operating Officer, Association of Clinical Research Organizations (ACRO)
  • David Borasky, Vice President, Compliance Review Solutions, WCG
  • Janice Chang, Chief Executive Officer, TransCelerate
  • Karla Childers, Head, Bioethics-based Science & Technology Policy, Office of the Chief Medical Officer, Johnson & Johnson
  • Janet Vessotskie, Deputy Vice President of Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Captain Julienne Vaillancourt, Center for Biologics Evaluation and Research (CBER), FDA
  • Karin Hoelzer, Director of Policy and Regulatory Affairs, National Organization for Rare Disorders (NORD)
  • Valen Keefer, Patient Advocate, Educator, Consultant, Thermo Fisher Scientific and Otsuka America Pharmaceutical
  • Neena Nizar, Executive Director, Founder, Jansen's Foundation
  • Harpreet Singh , CDER, FDA
  • Lisa Bennett, Principal Quality Lead, Roche
  • Kenneth Getz, Executive Director, Tufts Center for the Study of Drug Development; Professor, Tufts University School of Medicine
  • Chris Labaki, Post-doctoral Research Fellow, Dana-Farber Cancer Institute (DFCI), Broad Institute of MIT, Harvard
  • Vinod (Vinny) Parthasarathy, Senior Clinical Monitoring Director, Medtronic
  • Joanne (Jo) Spallone, Clinical Quality Consultant (JS GCP Clinical Consulting Services, LLC); Retired from Novartis Pharmaceuticals
  • Sally Okun, Executive Director, Clinical Trials Transformation Initiative (CTTI)

Day 2 (in order of appearance):

  • Celia Witten, Deputy Center Director, CBER, FDA
  • Bray Patrick-Lake, Center for Devices and Radiological Health (CDRH), FDA
  • John Beigel, Associate Director for Clinical Research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH)
  • Margaret Mooney, Associate Director, Chief, Clinical Investigations Branch (CIB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)
  • Salina Waddy, Associate Director, CTSA Program Clinical Affairs, Chief, CTSA Program Clinical Affairs Branch, Division of Clinical Innovation, Clinical Affairs Branch, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)
  • Paul Kluetz, Deputy Director, Oncology Center for Excellence (OCE), FDA
  • John H. Alexander, Professor of Medicine/Cardiology, Duke Clinical Research Institute, Duke University; Co-Chair, CTTI
  • Jeffrey Blank, Adult Patient with Cystic Fibrosis
  • Marianne Chase, Senior Director of Clinical Trial Operations, Neurological Clinical Research Institute/ Healey & AMG Center for ALS at Mass General Hospital
  • Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, Bristol-Myers Squibb
  • Nina Movsesyan, Manager, Clinical Research Programs, Metabolic Disorders Division, CHOC Children’s Hospital Orange County
  • Veronica Suarez, Global Product Leader, Vaccines Innovation Unit, CSL
  • Kassa Ayalew , CDER, FDA
  • Cindy Geoghegan, Patient Advocate, Advisor, and Activist
  • Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare
  • Patrick Naldony, Global Head, Clinical Data Management, Clinical Sciences & Operations, Sanofi
  • Pamela Tenaerts, Chief Scientific Officer, Medable
  • Ramya Thota, Investigator, Intermountain Health
  • Marion Wolfs, Head, Risk Management and Central Monitoring Oncology, Johnson & Johnson Innovative Medicine
  • M. Khair ElZarrad, Director, Office of Medical Policy, CDER, FDA

Additional Resources:

Virtual Public Workshop to Enhance Clinical Study Diversity