NEWS & EVENTS
Digital Clinical Trials Workshop: Creating a Vision for the Future
April 1 - 2, 2019
National Institutes of Health, Lister Hill Auditorium
Description

Clinical trial research is a cornerstone of NIH’s work, and using digital technology to conduct that research could be transformative. This technology has the potential not only to reduce the cost and time for research; it also will benefit patients.

The use of advanced analytics, such as artificial intelligence, machine learning and data mining can facilitate better screening of patients, ensuring that only those likely to respond to the trial intervention will be selected for trials. Likewise, the use of long-distance communications technology, such as FaceTime, Skype, telehealth services, and other types of virtual visits, can assure more complete patient follow-ups—and in the end, more successful trial outcomes.

Agenda

9:00 - 9:10 AM
-
Welcome and Logistics

9:10 - 9:25 AM
-
Opening Remarks from the Division Director of NHLBI and NSF Division Director for Computer and Information Science and Engineerin
Investment in Clinical Trials: A Path Forward

David Goff, MD, PhD; Director, Division of Cardiovascular Sciences, National Heart, Lung, Blood Institute

Walter (Rance) Cleaveland, PhD; Director, Division of Computing and Communication Foundations, National Science Foundation

9:25 - 9:50 AM
-
Workshop Objectives, Charge, and Presentation
Digital Clinical Trials and the 21st Century Cures Act

Robert M. Califf, MD, MACC; Duke University

9:50 – 10:30 AM
-
KEYNOTE SESSION

Digital Clinical Trials: It’s Not (all) About The Tech
Steven Steinhubl, MD; Scripps Research Translational Institute - Director of Digital Medicine

Digital Clinical Trials: It’s Not (all) About The Tech (Part Deux)
Amy Abernethy, MD, PhD: Deputy Commissioner, Food and Drug Administration

10:30 – 10:45 AM
-
MORNING BREAK

10:45 AM – 12:10 PM
-
SESSION 1
CURRENT STATUS OF DIGITAL TRIALS AND THE PATH FORWARD

Session Moderator: Pamela Tenaerts, MD - Executive Director, Clinical Trial Transformation Initiative (CTTI)

Clinical Trials Transformation Initiative: Decentralized Clinical Trials and Mobile Technologies
Pamela Tenaerts, MD, MBA; Duke University

Direct Engagement of Participants and mHealth Data Collection using The Eureka Research Platform
Mark Pletcher, MD, MPH; University California San Francisco

Trials, Tribulations, Victories - Transitioning a Clinical Trial to a Registry Using Digital technology
Naveen Pereira, MD; Mayo Rochester

What Makes a Digital Trial in Medicine Development?
Craig Lipset, MBA; Pfizer

PANEL DISCUSSION

12:10 – 12:45 PM
-
LUNCH BREAK

12:45 – 1:45 PM
-
SESSION 2
RECRUITMENT AND RETENTION IN DIGITAL TRIALS

Session Moderator: John Wilbanks, Chief Commons Officer at Sage Bionetworks

Ethics Frameworks for Digital Clinical Trials
John Wilbanks, B.A.; Sage Bionetworks

Recruitment with social media, digital registries, EHR and other digital strategies
Gil Alterovitz, PhD; Harvard University

A Patient-Centric Approach to Clinical Research
Scarlet Shore; Verily

Techniques to Improve Patient Recruitment, Engagement and Retention in Digital Trials
Beth Mynatt, PhD; Institute for People and Technology (IPaT), Georgia Tech

PANEL DISCUSSION

1:45 – 3:15 PM
-
SESSION 3
DELIVERING INTERVENTIONS IN DIGITAL SPACE

Session Moderator: Robert Harrington, MD; Professor of Medicine and Chairman of the Department of Medicine at Stanford University Stanford University, President, American Heart Association

Measuring Interventions, Outcomes and Biomarkers Digitally
Mintu Turakhia, MD, MAS; Director of Center for Digital Health Stanford University

A SMART Approach to Clinical Trial Data Generation and Workflow: A Standards-based Interface to Health Systems and the Patient
Ken Mandl, MD, MPH; Harvard University/Boston Children’s (Pediatric Perspective)

Bridging the Digital Divide in Health Systems for Clinical Trials
Adrian Hernandez, MD; Duke University (Adult Perspective)

Navigating Safety Monitoring in Digital Clinical Trials
Kenzie Preston, PhD; National Institute on Drug Abuse/National Institutes of Health

Strategies for Maintaining Participant Engagement with Digital Trials
Bonnie Spring, PhD; Northwestern University

PANEL DISCUSSION

3:15 – 3:35 PM
-
CLINICAL TRIALIST PANEL DISCUSSION

  1. Steven Grinspoon, MD; Professor of Medicine, Harvard Medical School
  2. Don S. Dizon, MD, FACP, FASCO; Director of Medical Oncology, Rhode Island Hospital, Professor of Medicine, Brown University
  3. Harmony Reynolds, MD, Saul J. Farber Associate Professor of Medicine at NYU School of Medicine

3:35 – 3:45 PM
-
AFTERNOON BREAK

3:45 – 5:00 PM
-
SESSION 4
ARE WE WIDENING OR BRIDGING A DIGITAL DIVIDE WITH DIGITAL CLINICAL TRIALS?

Session Moderator: Luis Belen; Chief Executive Officer at National Health IT Collaborative for the Underserved

Title: pending
Kandi Verlarde, MPH; VA Cooperative Studies Program

Older Adults and Digital Research: What Have We Learned and Where Do We Need to Go
Sara Czaja, PhD; Cornell University

Access, Utilization Patterns, and Preferences Among Subgroups That Can Lead to Differential Benefits or Disparities
Herman Taylor, MD; Director of Cardiovascular Research Institute, Morehouse School of Medicine

PANEL DISCUSSION

5:00 PM
-
AJOURN DAY ONE

9:00 - 9:15 AM
-
Opening Remarks from the Director of NCI’s Coordinating Center for Clinical Trials (CCCT}
Leveraging Digital Technology for Cancer Clinical Trials

Sheila Prindiville, MD, MPH; Director, Coordinating Center for Clinical Trials, Office of the Director, National Cancer Institute

9:15 – 10:15 AM
-
SESSION 5
DIGITAL TRIAL ANALYTICS

Session Moderator: Dr. Harlan Krumholz, MD; Professor of Medicine, Yale University, Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation

Advanced Analytics Including Artificial Intelligence 
Benjamin Marlin, PhD; College of Information and Computer Sciences at UMass Amherst

Learning How and When to Optimally Intervene: Trials and Analytics for the Design of Precision Behavioral Interventions
Predrag Klasjna, PhD; University of Michigan

DIGITAL TRIAL ANALYTICS: Analytics at Scale with Real World Data
Bharat Rao, PhD; KPMG

PANEL DISCUSSION

10:15 – 11:15 AM
-
SESSION 6
ENVIRONMENTAL AND REGULATORY ASPECTS OF DIGITAL CLINICAL TRIALS

Session Moderator: Teresa Zayas-Caban, PhD; Office of the National Coordinator

FDA Mobile Digital Health Guidance
Bakul Patel, PhD; Food and Drug Administration, Center for Devices and Radiologic Health

Digital Clinical Trials and Human Research Subject Protections: Some Thoughts
Ivor Pritchard, PhD; Office of Human Research Protection, Health and Human Services

PANEL DISCUSSION

11:15 AM – 12:30 PM
-
SESSION 7
Workshop Summary: Critical Implications, Remaining Questions & Digital Trial Needs

Session Moderator: Omer Inan, PhD; Georgia Tech, School of Electrical and Computer Engineering

Clinical Trialist Panel Discussion:

Steven Grinspoon, MD; Professor of Medicine, Harvard Medical School

Don S. Dizon, MD, FACP, FASCO; Director of Medical Oncology, Rhode Island Hospital, Professor of Medicine, Brown University

Harmony Reynolds, MD, Saul J. Farber Associate Professor of Medicine at NYU School of Medicine

  1. Critical Implications for Clinical Trials
  2. Digital Trial Needs
  3. Remaining Questions

12:30 – 1:00 PM
-
WRAP UP AND CONCLUSION