Study Design

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.

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:

Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic

CTTI Project: Clinical Trials Issues Related to COVID-19

 

Webinar Presenters:

  • David Borasky (WIRB-Copernicus Group)
  • Sara Calvert (Clinical Trials Transformation Initiative)
  • M. Khair ElZarrad (Food and Drug Administration/CDER)
  • Cindy Geoghegan (Individual Patient Representative/Caregiver)
  • Colleen Rouse (Cleveland Clinic)
  • Pamela Tenaerts (Clinical Trials Transformation Initiative)

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Designing High-Quality COVID-19 Treatment Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Pamela Tenaerts (Clinical Trials Transformation Initiative)
  • Janet Woodcock (FDA, CDER)
  • Ed Cox (Regeneron Pharmaceuticals, Inc.)
  • Martin Landray (University of Oxford)
  • John Marshall (WHO Clinical Characterization and Management Working Group, Unity Health CA)
  • Karlin Schroeder (Parkinson's Foundation)
  • Fergus Sweeney (European Medicines Agency)
  • Ann Meeker O'Connell (Vertex Pharmaceuticals)

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