If you conduct or regularly read randomized controlled trials (RCTs), you’re likely familiar with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. This month, CONSORT received its most substantial update since 2010 with the release of CONSORT 2025, alongside the upcoming companion update of SPIRIT 2025 (Standard Protocol Items: Recommendations for Interventional Trials). Both are essential references for researchers committed to improving the transparency and reproducibility of clinical trials.
While the 2010 statement already emphasized items like trial registration and detailed methodology, the 2025 update reflects a deeper cultural transformation. It formally integrates the principles of Open Science, echoing the broader shift toward default transparency and greater public accountability in the creation and communication of scientific knowledge.
As defined by UNESCO:
An inclusive construct that combines various movements and practices aiming to make multilingual scientific knowledge openly available, accessible and reusable for everyone, to increase scientific collaborations and sharing of information for the benefits of science and society, and to open the processes of scientific knowledge creation, evaluation and communication to societal actors beyond the traditional scientific community.
Key Changes
CONSORT 2025 expands the checklist from 25 to 30 items. New components emphasize data sharing, patient and public involvement, detailed harms assessment, and explicit descriptions of how interventions and comparators are delivered. This structural redesign reinforces a cultural transition: from possible transparency to default transparency.
Recognizing the Rise of AI
The update also anticipates the growing integration of artificial intelligence (AI) into clinical trials—either as decision-support tools or interventions themselves. Many journals have already issued guidance on the use of generative AI, and CONSORT 2025 echoes this concern by encouraging clear, reproducible, and ethically responsible documentation when trials involve algorithmic models, adaptive logic, or machine learning-based decision systems. In this context, transparency isn’t just about access—it’s about explainability and accountability, core tenets of Open Science.
A Cultural Evolution
Ultimately, CONSORT 2025 is more than a technical upgrade—it’s a cultural statement. It signals a shared vision for the future of scientific inquiry, where knowledge is co-created, verifiable, and ethically grounded. The academic community is now invited not only to comply, but to lead in cultivating an open, trustworthy, and socially responsive research ecosystem.