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      Decentralized research technology use in multicenter clinical research studies based at U.S. academic research centers

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          Abstract

          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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          Most cited references24

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          Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study.

          The aims of the present study were to define the prevalence of untreated atrial fibrillation (AF) in a systematic screening program using intermittent ECG recordings among 75- to 76-year-old individuals and to study the feasibility of initiating protective oral anticoagulant (OAC) treatment.
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            Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

            Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement.
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              A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

              Introduction: The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.). Methods: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. Results: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. Conclusions: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.
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                Author and article information

                Journal
                J Clin Transl Sci
                J Clin Transl Sci
                CTS
                Journal of Clinical and Translational Science
                Cambridge University Press (Cambridge, UK )
                2059-8661
                2023
                08 November 2023
                : 7
                : 1
                : e250
                Affiliations
                [ 1 ] University of Utah , Salt Lake City, UT, USA
                [ 2 ] Doxy.me Inc. , Rochester, NY, USA
                [ 3 ] Medical University of South Carolina , Charleston, SC, USA
                [ 4 ] University of Iowa , Iowa City, IA, USA
                [ 5 ] University of South Florida , Tampa, FL, USA
                Author notes
                Corresponding author: M. R. Cummins, PhD, RN, FAAN, FACMI; Email: mollie.cummins@ 123456utah.edu
                Author information
                https://orcid.org/0000-0001-7078-8479
                https://orcid.org/0000-0003-1350-5764
                Article
                S2059866123006787
                10.1017/cts.2023.678
                10790101
                38229901
                dd496567-8e22-4299-8801-a72e798d8b29
                © The Author(s) 2023

                This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NoDerivatives licence ( http://creativecommons.org/licenses/by-nd/4.0/), which permits re-use, distribution, and reproduction in any medium, provided that no alterations are made and the original article is properly cited.

                History
                : 27 March 2023
                : 06 September 2023
                : 02 November 2023
                Page count
                Tables: 2, References: 45, Pages: 7
                Categories
                Research Article
                Research Methods and Technology
                Decentralized Research: Realizing the Promise of Virtual Clinical Trials

                biomedical research,clinical research informatics,informatics,data coordinating centers,decentralized trials,decentralized research,digital health

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