Decentralized research technology use in multicenter clinical research studies based at US academic research centers

被引:2
作者
Cummins, Mollie R. [1 ,2 ]
Burr, Jeri [1 ]
Young, Lisa [1 ]
Yeatts, Sharon D. [3 ]
Ecklund, Dixie J. [4 ]
Bunnell, Brian E. [2 ,5 ]
Dwyer, Jamie P. [1 ]
VanBuren, John M. [1 ]
机构
[1] Univ Utah, Salt Lake City, UT 84112 USA
[2] Doxy me Inc, Rochester, NY 14623 USA
[3] Med Univ South Carolina, Charleston, SC USA
[4] Univ Iowa, Iowa City, IA USA
[5] Univ S Florida, Tampa, FL USA
关键词
Biomedical research; clinical research informatics; informatics; data coordinating centers; decentralized trials; decentralized research; digital health; ATRIAL-FIBRILLATION; TRIALS;
D O I
10.1017/cts.2023.678
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction:During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there's a pressing need to evaluate current decentralization practices and develop appropriate research, education, and operations infrastructure. The purpose of this study was to examine current adoption of decentralization technologies in a sample of clinical research studies conducted by academic research organizations (AROs).Methods:The setting was three data coordinating centers in the U.S. These centers initiated coordination of 44 clinical research studies during or after 2020, with national recruitment and enrollment, and entailing coordination between one and one hundred sites. We determined the decentralization technologies used in these studies.Results:We obtained data for 44/44 (100%) trials coordinated by the three centers. Three technologies have been adopted across nearly all studies (98-100%): eIRB, eSource, and Clinical Trial Management Systems. Commonly used technologies included e-Signature (32/44, 73%), Online Payments Portals (26/44, 59%), ePROs (23/44, 53%), Interactive Response Technology (22/44, 50%), Telemedicine (19/44, 43%), and eConsent (18/44, 41%). Wearables (7/44,16%) and Online Recruitment Portals (5/44,11%) were less common. Rarely utilized technologies included Direct-to-Patient Portals (1/44, 2%) and Home Health Nurse Portals (1/44, 2%).Conclusions:All studies incorporated some type of decentralization technology, with more extensive adoption than found in previous research. However, adoption may be strongly influenced by institution-specific IT and informatics infrastructure and support. There are inherent needs, responsibilities, and challenges when incorporating decentralization technology into a research study, and AROs must ensure that infrastructure and informatics staff are adequate.
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页数:7
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共 45 条
  • [31] A comparative effectiveness study of eSource used for data capture for a clinical research registry
    Nordo, Amy Harris
    Eisenstein, Eric L.
    Hawley, Jeffrey
    Vadakkeveedu, Sai
    Pressley, Melissa
    Pennock, Jennifer
    Sanderson, Iain
    [J]. INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS, 2017, 103 : 89 - 94
  • [32] OnCore CTMS Enterprise Research System, Clinical Research Software
  • [33] Decentralized clinical trials (DCTs): A few ethical considerations
    Petrini, Carlo
    Mannelli, Chiara
    Riva, Luciana
    Gainotti, Sabina
    Gussoni, Gualberto
    [J]. FRONTIERS IN PUBLIC HEALTH, 2022, 10
  • [34] PROMIS, Patient-Reported Outcomes Measurement Information System)
  • [35] Randomized Trials with Repeatedly Measured Outcomes: Handling Irregular and Potentially Informative Assessment Times
    Pullenayegum, Eleanor M.
    Scharfstein, Daniel O.
    [J]. EPIDEMIOLOGIC REVIEWS, 2022, 44 (01) : 121 - 137
  • [36] Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus
    Santa-Ana-Tellez, Yared
    Lagerwaard, Bart
    de Jong, Amos J.
    Gardarsdottir, Helga
    Grobbee, Diederick E.
    Hawkins, Kimberly
    Heath, Megan
    Zuidgeest, Mira G. P.
    [J]. DRUG DISCOVERY TODAY, 2023, 28 (04)
  • [37] Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP)
    Sarraju, Ashish
    Seninger, Clark
    Parameswaran, Vijaya
    Petlura, Christina
    Bazouzi, Tamara
    Josan, Kiranbir
    Grewal, Upinder
    Viethen, Thomas
    Mundl, Hardi
    Luithle, Joachim
    Basobas, Leonard
    Touros, Alexis
    Senior, Michael J. T.
    De Lombaert, Koen
    Mahaffey, Kenneth W.
    Turakhia, Mintu P.
    Dash, Rajesh
    [J]. NPJ DIGITAL MEDICINE, 2022, 5 (01)
  • [38] Use of patient portals to support recruitment into clinical trials and health research studies: results from studies using MyChart at one academic institution
    Sherman, Scott E.
    Langford, Aisha T.
    Chodosh, Joshua
    Hampp, Carina
    Trachtman, Howard
    [J]. JAMIA OPEN, 2022, 5 (04)
  • [39] Social Interventions Research and Evaluation Network (SIREN), ABOUT US
  • [40] Virtual conversational agents versus online forms: Patient experience and preferences for health data collection
    Soni, Hiral
    Ivanova, Julia
    Wilczewski, Hattie
    Bailey, Alexandra
    Ong, Triton
    Narma, Alexa
    Bunnell, Brian E.
    Welch, Brandon M.
    [J]. FRONTIERS IN DIGITAL HEALTH, 2022, 4