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The National Heart, Lung, and Blood Institute (NHLBI), in partnership with the National Science Foundation (NSF) and the NIH Office of Behavioral and Social Sciences Research (OBSSR), hosted a workshop on April 1-2, 2019 to discuss the potential transformation of NIH-funded clinical trial research by leveraging digital technologies including data analytics. Development of diverse digital technologies and analytics has impelled a paradigm shift in how clinical trials can be conducted. This development points to opportunities to advance the clinical trial process on both scientific and cost effective grounds while moving more towards a more patient-centered trial experience. This workshop convened experts in the field of clinical trials and digital health technology to identify best practices, gaps, barriers, and future priorities for leveraging digital technologies for clinical trials.
Clinical trial research is a key component of the NIH research portfolio, and using digital technology to conduct research could be transformative. Digital technology has the potential not only to reduce the cost and time for research, but it may also benefit patients by offering research opportunities that are more patient-centered with the ability to quickly address critical health-related questions.
The use of advanced analytics, such as artificial intelligence (AI), can facilitate better screening of patients, ensuring that representative groups of appropriate participants will be selected for trial interventions, and may predict response to interventions. 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.
Before making any decisions about how to advance the use of this technology, however, researchers must consider a host of issues, including racial, ethnic, and socioeconomic equity, aging populations, gender differences, cultural norms, and participant preferences that might influence access and utilization, and how computational simulations could be used to reduce the sample size and length of trials.
Objective | Strategies |
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1. Leverage digital technology to transform clinical trials |
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2. Enhance clinical trials with technology |
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3. Increase participant diversity |
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4. Implementation strategies using digital technology; what can be done now and future priorities |
What can be done now: Form cross-disciplinary partnerships with industry, government and academia to learn and work through complex processes with digital trials. This partnership would work towards the following:
What can be done in the future:
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5. Implementation strategies including workforce considerations |
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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
Robert M. Califf, MD, MACC; Duke University
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
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
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
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
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
Sheila Prindiville, MD, MPH; Director, Coordinating Center for Clinical Trials, Office of the Director, National Cancer Institute
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
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
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