TY - JOUR
T1 - Digitizing clinical trials
AU - Inan, O. T.
AU - Tenaerts, P.
AU - Prindiville, S. A.
AU - Reynolds, H. R.
AU - Dizon, D. S.
AU - Cooper-Arnold, K.
AU - Turakhia, M.
AU - Pletcher, M. J.
AU - Preston, K. L.
AU - Krumholz, H. M.
AU - Marlin, B. M.
AU - Mandl, K. D.
AU - Klasnja, P.
AU - Spring, B.
AU - Iturriaga, E.
AU - Campo, R.
AU - Desvigne-Nickens, P.
AU - Rosenberg, Y.
AU - Steinhubl, S. R.
AU - Califf, R. M.
N1 - Funding Information:
The workshop that resulted in this work was funded through the National Institutes of Health (NIH), National Heart, Lung and Blood Institute (NHLBI), and the National Science Foundation (NSF) under Grant Number 1922762. The paper was also supported in part by both the Extramural and Intramural research programs of the NIH (NHLBI and NIDA). S.R.S. is supported in part by a grant from the National Center for Advancing Translational Sciences/NIH (grant UL1TR001114). Any opinions, findings, and conclusions or recommendations expressed in this paper are those of the authors and do not necessarily reflect the views of the NHLBI, the NIH, or the NSF. We thank W. Nilsen (NSF) for her contributions to this effort; her input was invaluable. We also acknowledge the following people for their contributions to and/ or participation in the NIH/NSF Digital Clinical Trials Workshop: D. Goff, W. Cleaveland, A. Abernathy, N. Pereira, C. Lipset, J. Wilbanks, G. Alterovitz, S. Shore, B. Mynatt, R. Harrington, A. Hernandez, S. Grinspoon, L. Belen, K. Velarde, S. Czaja, H. Taylor, B. Rao, T. Zayas-Caban, B. Patel, I. Prichard, A. Kravets, D. Wolff-Hughes, J. Bamdad, B. Newsome, R. Roper, C. Sasiela, H. Nicastro, A. Lee, N. Redmond, V. Sachdev, P. Schum, S. Czajkowski, A. Oh, T. Lash, R. Conroy, C. Aklin, B. Jean-Francois, V. Florance, N. Langhals, C. Lungu, D. Whittingslow, and N. Gurel.
Funding Information:
All authors participated in the NIH/NSF Digital Clinical Trials Workshop held in Bethesda, MD in April 2019 where the concepts described in this manuscript were discussed and formed, and participated in the writing, editing, and review of the manuscript. O.T.I. acquired funding from the NSF for the workshop.
Funding Information:
M.T. reports grants from Janssen Inc, personal fees from Medtronic Inc, grants from AstraZeneca, other from AliveCor, personal fees from Abbott, grants from Boehringer Ingelheim, personal fees from Precision Health Economics, personal fees from iBeat Inc, grants and personal fees from Cardiva Medical, personal fees from iRhythm, grants from Bristol Myers Squibb, grants from American Heart Association, grants from SentreHeart, personal fees from Novartis, personal fees from Biotronik, personal fees from Sanofi-Aventis, personal fees from Pfizer, grants from Apple, outside the submitted work; and Dr. M.T. is an editor for JAMA Cardiology. B. Spring is on the Scientific Advisory Board for Actigraph. O.T.I. is a Scientific Advisor for Physiowave, Inc. and a Co-Founder and Scientific Advisor for Cardiosense, has research funding for his lab from Hill-Rom Services, Inc. and Murata Americas, and has IP licensed by Physiowave, TandemLaunch, and Cardiosense. Dr. K.D.M.’s research lab receives philanthropic support from Eli Lily and he has consulted on using real world evidence for Merck. M.J.P. is supported by the NIH to develop and maintain a research platform to support digital trials and mHealth data collection. S.R.S. has served as a medical advisor for Janssen, Otsuka, Livongo, DynoSense, BioSense, and Spry Health. H.R. has received donations of OCT catheters for a research study from Abbott Vascular and telemetry monitors from BioTelemetry, Inc. Dr. Krumholz works under contract with the Centers for Medicare & Medicaid Services to support quality measurement programs; was a recipient of a research grant, through Yale, from Medtronic and the Food and Drug Administration to develop methods for post-market surveillance of medical devices; was a recipient of a research grant with Medtronic and is the recipient of a research grant from Johnson & Johnson, through Yale University, to support clinical trial data sharing; was a recipient of a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; receives payment from the Arnold & Porter Law Firm for work related to the Sanofi clopidogrel litigation, from the Martin/ Baughman Law Firm for work related to the Cook Celect IVC filter litigation, and from the Siegfried and Jensen Law Firm for work related to Vioxx litigation; chairs a Cardiac Scientific Advisory Board for UnitedHealth; was a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science, the Advisory Board for Facebook, and the Physician Advisory Board for Aetna; and is the co-founder of HugoHealth, a personal health information platform, and co-founder of Refactor Health, an enterprise healthcare AI-augmented data management company.R.C. reports employment with Verily Life Sciences and Google Health, board membership at Cytokinetics, and status of former commissioner of the US FDA.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12/1
Y1 - 2020/12/1
N2 - 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.
AB - 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.
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U2 - 10.1038/s41746-020-0302-y
DO - 10.1038/s41746-020-0302-y
M3 - Article
C2 - 32821856
AN - SCOPUS:85088863609
VL - 3
JO - npj Digital Medicine
JF - npj Digital Medicine
SN - 2398-6352
IS - 1
M1 - 101
ER -
