Digitizing clinical trials
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 sys...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2020-07-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-020-0302-y |
| _version_ | 1797641280972390400 |
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| author | 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 |
| author_facet | 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 |
| author_sort | O. T. Inan |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T13:43:19Z |
| format | Article |
| id | doaj.art-74588ba7851c4d4086f8aa8b6b55488d |
| institution | Directory Open Access Journal |
| issn | 2398-6352 |
| language | English |
| last_indexed | 2024-03-11T13:43:19Z |
| publishDate | 2020-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj.art-74588ba7851c4d4086f8aa8b6b55488d2023-11-02T11:15:53ZengNature Portfolionpj Digital Medicine2398-63522020-07-01311710.1038/s41746-020-0302-yDigitizing clinical trialsO. T. Inan0P. Tenaerts1S. A. Prindiville2H. R. Reynolds3D. S. Dizon4K. Cooper-Arnold5M. Turakhia6M. J. Pletcher7K. L. Preston8H. M. Krumholz9B. M. Marlin10K. D. Mandl11P. Klasnja12B. Spring13E. Iturriaga14R. Campo15P. Desvigne-Nickens16Y. Rosenberg17S. R. Steinhubl18R. M. Califf19School of Electrical and Computer Engineering, Georgia Institute of TechnologyClinical Trials Transformation Initiative, Duke UniversityCoordinating Center for Clinical Trials, Office of the Director, National Cancer Institute at the National Institutes of HealthSchool of Medicine, New York UniversityThe Lifespan Cancer Institute, Brown UniversityNational, Heart, Lung and Blood Institute at the National Institutes of HealthVA Palo Alto Health Care System and the Center for Digital Health, Stanford UniversityDepartment of Epidemiology and Biostatistics, University of CaliforniaIntramural Research Program of the National Institute on Drug Abuse at the National Institutes of HealthThe Center for Outcomes Research, Yale New Haven Hospital, Yale UniversityCollege of Information and Computer Sciences, University of Massachusetts at AmherstComputational Health Informatics Program at Boston Children’s Hospital, Departments of Biomedical Informatics and Pediatrics, Harvard Medical SchoolSchool of Information, University of MichiganNorthwestern University Feinberg School of MedicineNational Heart, Lung, and Blood Institute at the National Institutes of HealthNational Heart, Lung, and Blood Institute at the National Institutes of HealthNational Heart, Lung, and Blood Institute at the National Institutes of HealthNational Heart, Lung, and Blood Institute at the National Institutes of HealthScripps Research Translational InstituteSchool of Medicine, Duke UniversityAbstract 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.https://doi.org/10.1038/s41746-020-0302-y |
| spellingShingle | 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 Digitizing clinical trials npj Digital Medicine |
| title | Digitizing clinical trials |
| title_full | Digitizing clinical trials |
| title_fullStr | Digitizing clinical trials |
| title_full_unstemmed | Digitizing clinical trials |
| title_short | Digitizing clinical trials |
| title_sort | digitizing clinical trials |
| url | https://doi.org/10.1038/s41746-020-0302-y |
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