Study Operations

Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

JUNE 12, 2014 TO JUNE 13, 2014

CTTI Project: Single IRB

Meeting Objectives:

  • Discuss practices, implementation strategies, and solicit additional suggestions for increasing the use of central IRBs for multi-center clinical trials
  • Present findings from the CTTI Central IRB Advancement project’s collection of IRB authorization agreements and standard operating procedures
  • Obtain additional feedback to refine proposed IAA template and tools

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

DAY 1 – JUNE 12 , 2014

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

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.

New Resources for Designing and Running Master Protocols

CTTI Project: Master Protocol Studies

 

Webinar Presenters:

  • Abby Bronson, Edgewise Therapeutics
  • Marianne Chase, Massachusetts General Hospital
  • Daniel Millar, Janssen R&D
  • Nick Richardson, FDA, CDER

Webinar Resources:

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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

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.

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