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. 2023 Sep;57(5):1081-1098.
doi: 10.1007/s43441-023-00540-2. Epub 2023 Jun 30.

Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment

Lidia Betcheva  1 , Jennifer Y Kim  2 , Feryal Erhun  3 , Nektarios Oraiopoulos  3 , Kenneth Getz  2
Affiliations

Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment

Lidia Betcheva et al. Ther Innov Regul Sci. 2023 Sep.

Abstract

Recently, there has been a growing interest in understanding how decentralized clinical trial (DCT) solutions can mitigate existing challenges in clinical development, particularly participant burden and access, and the collection, management, and quality of clinical data. This paper examines DCT deployments, emphasizing how they are integrated and how they may impact clinical trial oversight, management, and execution. We propose a conceptual framework that employs systems thinking to evaluate the impact on key stakeholders through a reiterative assessment of pain points. We conclude that decentralized solutions should be customized to meet patient needs and preferences and the unique requirements of each clinical trial. We discuss how DCT elements introduce new demands and pressures within the existing system and reflect on enablers that can overcome DCT implementation challenges. As stakeholders look for ways to make clinical research more relevant and accessible to a larger and more diverse patient population, further robust and granular research is needed to quantify the impact of DCTs empirically.

Keywords: Adoption and implementation of DCTs; Decentralized clinical trials (DCTs); Pain points; Stakeholder analysis; Systems thinking.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Figure 1
Figure 1
A Systems View of Pain Points for Participants, Sites, and Sponsors
Figure 2
Figure 2
The Process of Emergence and Alleviation of Pain Points for Clinical Trial Participants
See this image and copyright information in PMC

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MeSH terms