Digitizing clinical trials

O T Inan; P Tenaerts; S A Prindiville; H R Reynolds; D S Dizon; K Cooper-Arnold; M Turakhia; M J Pletcher; K L Preston; H M Krumholz; B M Marlin; K D Mandl; P Klasnja; B Spring; E Iturriaga; R Campo; P Desvigne-Nickens; Y Rosenberg; S R Steinhubl; R M Califf

doi:10.1038/s41746-020-0302-y

Digitizing clinical trials

NPJ Digit Med. 2020 Jul 31:3:101. doi: 10.1038/s41746-020-0302-y. eCollection 2020.

Authors

O T Inan¹, P Tenaerts², S A Prindiville³, H R Reynolds⁴, D S Dizon⁵, K Cooper-Arnold^{6

7}, M Turakhia⁸, M J Pletcher⁹, K L Preston¹⁰, H M Krumholz^{11

12

13}, B M Marlin¹⁴, K D Mandl¹⁵, P Klasnja¹⁶, B Spring¹⁷, E Iturriaga¹⁸, R Campo¹⁸, P Desvigne-Nickens¹⁸, Y Rosenberg¹⁸, S R Steinhubl¹⁹, R M Califf^{20

21}

Affiliations

¹ School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA 30332 USA.
² Clinical Trials Transformation Initiative, Duke University, Durham, NC 27708 USA.
³ Coordinating Center for Clinical Trials, Office of the Director, National Cancer Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
⁴ School of Medicine, New York University, New York, NY 10003 USA.
⁵ The Lifespan Cancer Institute, Brown University, Providence, RI 02912 USA.
⁶ National, Heart, Lung and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
⁷ Present Address: Fortira at AstraZeneca, Gaithersburg, MD 20877 USA.
⁸ VA Palo Alto Health Care System and the Center for Digital Health, Stanford University, Stanford, CA 94305 USA.
⁹ Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143 USA.
¹⁰ Intramural Research Program of the National Institute on Drug Abuse at the National Institutes of Health, Baltimore, MD 21224 USA.
¹¹ The Center for Outcomes Research, Yale New Haven Hospital, Yale University, New Haven, CT 06510 USA.
¹² Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06510 USA.
¹³ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut 06510 USA.
¹⁴ College of Information and Computer Sciences, University of Massachusetts at Amherst, Amherst, MA 01003 USA.
¹⁵ Computational Health Informatics Program at Boston Children's Hospital, Departments of Biomedical Informatics and Pediatrics, Harvard Medical School, Boston, MA 02115 USA.
¹⁶ School of Information, University of Michigan, Ann Arbor, MI 48109 USA.
¹⁷ Northwestern University Feinberg School of Medicine, Chicago, IL 60611 USA.
¹⁸ National Heart, Lung, and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
¹⁹ Scripps Research Translational Institute, La Jolla, CA 92037 USA.
²⁰ School of Medicine, Duke University, Durham, NC 27710 USA.
²¹ Verily Life Sciences and Google Health, South San Francisco, CA 94080 USA.

Abstract

Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a "digital clinical trial" involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.

Keywords: Clinical trials; Translational research.

Publication types

Review