<b>Uji Klinik Terdesentralisasi: Mendefinisikan Ulang Partisipasi, Kuasa, dan Presisi dalam Riset Kesehatan</b>

Decentralized clinical trials (DCTs) have emerged as a transformative force in biomedical research, breaking down traditional boundaries and reshaping how evidence is generated, validated, and applied. By leveraging digital health technologies, real-world data, and remote engagement infrastructures, DCTs have the potential to democratize clinical research by improving inclusivity and accessibility. However, these opportunities come with challenges related to regulatory governance, technological ethics, and socio-political representation. This brief article explores both the conceptual and empirical foundations of DCTs, drawing from recent studies, international policy documents (such as white papers), regulatory initiatives, and global practice surveys. It examines the epistemological, operational, and normative shifts introduced by DCTs and proposes a framework for understanding their impact on three core dimensions of clinical science: participation, power, and precision. Ultimately, this article argues that DCTs are not merely a digital enhancement, but rather a fundamental reconfiguration of how health knowledge is generated and governed.

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Publication Details

Journal
MEDICINUS
Published
2025-06-02
DOI
https://doi.org/10.56951/trzykz54
Primary Topic
Healthcare Quality and Satisfaction
Type
article
Field-Weighted Citation Impact
0.00
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article

Uji Klinik Terdesentralisasi: Mendefinisikan Ulang Partisipasi, Kuasa, dan Presisi dalam Riset Kesehatan

Raymond R. Tjandrawinata
MEDICINUS
Healthcare Quality and Satisfaction
article

Uji Klinik Terdesentralisasi: Mendefinisikan Ulang Partisipasi, Kuasa, dan Presisi dalam Riset Kesehatan

Raymond R. Tjandrawinata
article en

Abstract

Decentralized clinical trials (DCTs) have emerged as a transformative force in biomedical research, breaking down traditional boundaries and reshaping how evidence is generated, validated, and applied. By leveraging digital health technologies, real-world data, and remote engagement infrastructures, DCTs have the potential to democratize clinical research by improving inclusivity and accessibility. However, these opportunities come with challenges related to regulatory governance, technological ethics, and socio-political representation. This brief article explores both the conceptual and empirical foundations of DCTs, drawing from recent studies, international policy documents (such as white papers), regulatory initiatives, and global practice surveys. It examines the epistemological, operational, and normative shifts introduced by DCTs and proposes a framework for understanding their impact on three core dimensions of clinical science: participation, power, and precision. Ultimately, this article argues that DCTs are not merely a digital enhancement, but rather a fundamental reconfiguration of how health knowledge is generated and governed.

MEDICINUSVol. 38(6)
Atma Jaya Catholic University of Indonesia (ID)
Openalex Percentile: Top 79%
Healthcare Quality and Satisfaction
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