Digital Clinical Trials Workshop: Creating a Vision for the Future

Background

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.

Workshop Objectives

1. Determine how best to leverage digital technology to transform clinical trials (e.g., decrease cost, improve enrollment and retention, adherence).
2. Review best practices that enhance the design and conduct of clinical trials, such as the use of videos, mobile apps, text-based messaging, wearable sensors, and other platforms.
3. Determine how to increase participant diversity and curb the "digital divide".
4. Determine what can be done now and what are future priorities.
5. Discuss implementation strategies using digital technology in future clinical trials, including workforce considerations and training needs.

Workshop Outcomes

WORKSHOP CHAIR

• Robert Califf, MD, MACC; Professor of Medicine, Division of Cardiology, Duke University; Verily

WORKSHOP LEADERS

• Wendy J. Nilsen, PhD, Smart and Connected Health Program, NSF
• Erin Iturriaga, DNP, MSN, RN, Division of Cardiovascular Sciences, NHLBI
• Rebecca Campo, PhD, Division of Cardiovascular Sciences, NHLBI
• Patrice Desvigne-Nickens, MD, Division of Cardiovascular Sciences, NHLBI
• Yves Rosenberg, MD, MPH, Division of Cardiovascular Sciences, NHLBI

WORKSHOP SPEAKERS/MODERATORS IN ORDER LISTED IN WORKSHOP AGENDA

• David Goff, MD, PhD, Division Director, Division of Cardiovascular Sciences, NHLBI
• Walter (Rance) Cleaveland, PhD, Division Director, Computing and Information Science and Engineering, NSF
• Steven Steinhubl, MD, Director of Digital Medicine, Scripps Research Translational Institute
• Amy Abernethy, MD, PhD, Deputy Commissioner, FDA
• Pamela Tenaerts, MD, MBA, Executive Director, Clinical Trial Transformation Initiative, Duke University
• Mark Pletcher, MD, MPH, Director Engagement of Participants and mHealth Data Collection, University of California San Francisco
• Naveen Pereira, MD, FACC, FAHA, Mayo Clinic Rochester
• Craig Lipset, MBA, Pfizer
• John Wilbanks, BA, Chief Commons Officer, Sage Bionetworks
• Gil Alterovitz, PhD, Harvard University
• Scarlet Shore, Verily
• Beth Mynatt, PhD, Institute for People and Technology, Georgia Tech
• Robert Harrington, MD, Chair, Department of Medicine, Stanford University; President, American Heart Association
• Mintu Turakhia, MD, MAS, Director of Center for Digital Health, Stanford University
• Ken Mandl, MD, MPH, Harvard University/Boston Children’s
• Adrian Hernandez, MD, Duke University
• Kenzie Preston, PhD, National Institute on Drug Abuse
• Bonnie Spring, PhD, Northwestern University
• 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, Associate Professor of Medicine, NYU School of Medicine
• Luis Belen, Chief Executive Officer, National Health IT Collaborative for the Underserved
• Kandi Velarde, MPH, Veterans Administration
• Sara Czaja, PhD, Cornell University
• Herman Taylor, MD, Director, Cardiovascular Research Institute, Morehouse School of Medicine
• Sheila Prindiville, MD, MPH, Director, Coordinating Center for Clinical Trials, Office of the Director, National Cancer Institute (NCI)
• Harlan Krumholz, MD, Professor of Medicine, Yale University; Director, Yale-New Haven Hospital Center for Outcomes Research and Evaluation
• Benjamin Marlin, PhD, College of Information and Computer Sciences, University of Massachusetts at Amherst
• Predrag Klasjna, PhD University of Michigan
• Bharat Rao, PhD, KPMG
• Teresa Zayas-Caban, PhD, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services (HHS)
• Bakul Patel, PhD, Center for Devices and Radiologic Health, FDA
• Ivor Prichard, PhD, Office of Human Research Protection, HHS
• Anna Kravets, PhD, Merck
• Omer Inan, PhD, School of Electrical and Computer Engineering, Georgia Tech

FEDERAL WORKING GROUP PARTICIPANTS

• Dana Wolff-Hughes, PhD, NIH Office of Behavioral and Social Sciences Research (OBSSR)
• Julie Bamdad, MSE, Division of Lung Disease, NHLBI
• Katharine Cooper-Arnold, MPH, Division of Cardiovascular Sciences, NHLBI
• Brad Newsome, PhD, Center for Translational Research and Implementation Science, NHLBI
• Rebecca Roper, MS, MPH, Center for Translational Research and Implementation Science, NHLBI
• Chris Sasiela, PhD, RAC, Office of Translational Alliances and Coordination, NHLBI
• Holly Nicastro, PhD, Division of Cardiovascular Sciences, NHLBI
• Albert Lee, PhD, Division of Cardiovascular Sciences, NHLBI
• Nicole Redmond, MD, PhD, MPH, Division of Cardiovascular Sciences, NHLBI
• Vandana Sachdev, MD, Division of Cardiovascular Sciences, NHLBI
• Paula Schum, MSN, RN, Division of Cardiovascular Sciences, NHLBI
• Susan Czajkowski, PhD, Chief of the Health Behaviors Research Branch, National Cancer Institute (NCI)
• April Oh, PhD, Health Communication and Informatics Research Branch, NCI
• Tiffani Lash, PhD, National Institute of Biomedical Imaging and Bioengineering (NIBIB)
• Richard Conroy, PhD, Office of Strategic Coordination, NIH Common Fund
• Courtney Aklin, PhD, Chief of Staff, National Institute on Minority Health and Health Disparities (NIMHD)
• Beda Jean-Francois, PhD, Clinical and Health Services Research Division, NIMHD
• Valerie Florance, PhD, Extramural Program Director, National Library of Medicine (NLM)
• Nick Langhals, PhD, Division of Translational Research, National Institute of Neurologic Disorders and Stroke (NINDS)
• Codrin Lungu, MD, Division of Clinical Research, NINDS