Peer-reviewedCC BY 4.0Communications Medicine
Governing accelerated evidence in real-time clinical trials
Abstract
The FDA’s real-time clinical trial initiative marks a pivotal shift in regulating clinical trials, yet accelerating data flows may outpace the governance, statistical safeguards, and inclusive infrastructure required for trustworthy evidence. To address these issues, the commentary identifies four key challenges and proposes a three-pillar governance framework to ensure rigorous, equitable, and continuously adaptive oversight and operations.
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BibTeX
@article{seixas2026governing,
title = {{Governing accelerated evidence in real-time clinical trials}},
author = {Azizi A. Seixas},
journal = {Communications Medicine},
year = {2026},
month = oct,
doi = {10.1038/s43856-026-01909-8},
url = {https://www.nature.com/articles/s43856-026-01909-8},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Governing accelerated evidence in real-time clinical trials
AU - Azizi A. Seixas
PY - 2026
DA - 2026/10/28
JO - Communications Medicine
DO - 10.1038/s43856-026-01909-8
UR - https://www.nature.com/articles/s43856-026-01909-8
AB - The FDA’s real-time clinical trial initiative marks a pivotal shift in regulating clinical trials, yet accelerating data flows may outpace the governance, statistical safeguards, and inclusive infrastructure required for trustworthy evidence. To address these issues, the commentary identifies four key challenges and proposes a three-pillar governance framework to ensure rigorous, equitable, and continuously adaptive oversight and operations.
SN - 2730-664X
ER -