Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jul 25;7(1):e170.
doi: 10.1017/cts.2023.597. eCollection 2023.

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned

Daniel F Hanley Jr  1   2 , Gordon R Bernard  3   4 , Consuelo H Wilkins  3   4   5 , Harry P Selker  6   7   8 , Jamie P Dwyer  9   10 , J Michael Dean  9 , Daniel Kelly Benjamin Jr  11   12 , Sarah E Dunsmore  13 , Salina P Waddy  13 , Kenneth L Wiley Jr  13 , Marisha E Palm  6   7   8 , W Andrew Mould  1   14 , Daniel F Ford  2 , Jeri S Burr  9 , Jacqueline Huvane  12 , Karen Lane  1   2 , Lori Poole  12 , Terri L Edwards  4 , Nan Kennedy  4 , Leslie R Boone  4 , Jasmine Bell  4 , Emily Serdoz  4 , Loretta M Byrne  4 , Paul A Harris  4   15
Affiliations

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned

Daniel F Hanley Jr et al. J Clin Transl Sci. .

Abstract

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

Keywords: CTSA; Decentralized trials; MyCap; hybrid trials; inclusive recruitment; remote data collection; remote intervention; remote recruitment; remote technology; remote trial monitoring; remote trials; rural recruitment; trial innovation network.

PubMed Disclaimer

Conflict of interest statement

Dr Benjamin, Jr. reports consultancy for Allergan, Melinta Therapeutics, and Sun Pharma Advanced Research Co. The remaining authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Decentralized elements of design for trials conducted by Trial Innovation Center (TIC) or Recruitment Innovation (RIC) Center investigators or through TIC or RIC coordinating centers.
Figure 2.
Figure 2.
Decentralized and hybrid options for data capture in REDCap and MyCap.
Figure 3.
Figure 3.
Examples of decentralized elements in Trial Innovation Network hybrid trials.
See this image and copyright information in PMC

References

    1. Rosa C, Marsch LA, Winstanley EL, Brunner M, Campbell ANC. Using digital technologies in clinical trials: current and future applications. Contemp Clin Trials. 2021;100:106219. doi: 10.1016/j.cct.2020.106219. - DOI - PMC - PubMed
    1. Shah M, Culp M, Gersing K, et al. Early vision for the CTSA program trial innovation network: a perspective from the national center for advancing translational sciences. Clin Translat Sci. 2017;10(5):311–313. doi: 10.1111/cts.12463. - DOI - PMC - PubMed
    1. Glossary of Industry Terms and Definitions. DTRA - Decentralized Trials & Research Alliance. n.d.. (https://www.dtra.org/1a-glossary). Accessed February 15, 2023.
    1. Alemayehu D, Hemmings R, Natarajan K, Roychoudhury S. Perspectives on virtual (Remote) clinical trials as the, new normal, to accelerate drug development. Clin Pharmacol Ther. 2022;111(2):373–381. doi: 10.1002/cpt.2248. - DOI - PubMed
    1. Thoelke K. There’s a silent crisis in clinical research. And it’s not Covid-19. STAT 2020. (https://www.statnews.com/2020/10/28/recruitment-retention-silent-crises-...). Accessed February 22, 2023.

LinkOut - more resources