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4 Modernizing clinical research: An administrative approach to unlocking the potential of decentralized clinical trials

Published online by Cambridge University Press:  11 April 2025

Jerry Tribout
Affiliation:
Case Western Reserve University
Heather Tribout
Affiliation:
Case Western Reserve University
Kathryn DiFrancesco
Affiliation:
Case Western Reserve University
Kylie Phillips
Affiliation:
Case Western Reserve University
Shannon Swiatkowski
Affiliation:
Case Western Reserve University
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Abstract

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Objectives/Goals: Decentralized clinical trials (DCTs) shift participation outside traditional sites. This poster explores innovative administrative strategies for incorporating decentralized elements, improving flexibility, access, and efficiency in clinical research. Methods/Study Population: Modern administrative approaches are crucial for unlocking DCT potential by streamlining logistics, enhancing participant experience, and ensuring regulatory compliance. Key innovations include expedited IRB Review: using innovative template language; innovative consent strategies – eConsent and remote/virtual and contactless enrollment; telehealth communications – Twilio (voice calls and text messages)/Zoom (virtual video visits); automated participant compensation and rideshare services – Greenphire ClinCard®; flexible data collection – automated recruitment/intake forms and research surveys – REDCap; mobile research unit/self-collection lab kits via mail. Implementing decentralization into your study unlocks the potential to rapidly recruit more diverse populations. Results/Anticipated Results: The integration of decentralized elements into clinical trials holds significant potential for reducing participant burden, thereby improving recruitment, retention, and overall trial efficiency. However, the success of decentralized clinical trials relies heavily on the implementation of modern administrative approaches that streamline operations and maintain regulatory compliance. Together, these administrative advancements not only enhance the operational flexibility of decentralized trials but also support the inclusion of diverse populations by reducing geographical and logistical barriers. Discussion/Significance of Impact: As decentralized clinical trials continue to evolve, the adoption and further innovation of modern administrative solutions will be essential in improving the overall efficiency and inclusivity of clinical research.

Type
Contemporary Research Challenges
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s), 2025. The Association for Clinical and Translational Science