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

Mollie R Cummins; Jeri Burr; Lisa Young; Sharon D Yeatts; Dixie J Ecklund; Brian E Bunnell; Jamie P Dwyer; John M VanBuren

doi:10.1017/cts.2023.678

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

J Clin Transl Sci. 2023 Nov 8;7(1):e250. doi: 10.1017/cts.2023.678. eCollection 2023.

Authors

Mollie R Cummins^{1

2}, Jeri Burr¹, Lisa Young¹, Sharon D Yeatts³, Dixie J Ecklund⁴, Brian E Bunnell^{5

2}, Jamie P Dwyer¹, John M VanBuren¹

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.

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.

Keywords: Biomedical research; clinical research informatics; data coordinating centers; decentralized research; decentralized trials; digital health; informatics.