It's All One Trial: a continuous master-protocol framework to accelerate development and confirmation of disease-modifying therapies for type 1 diabetes
Authors' conclusion
Implementing the OT model could shorten development timelines, lower capital barriers, conserve scarce clinical trial resources and better honour patient participation by maintaining continuous randomised follow-up, protocol-directed care and a more direct path from early biological effect to durable evidence for practice and regulation.
Study context
- Population
- Treatments aimed at preserving insulin secretion in people with recent-onset type 1 diabetes
- Exposure
- The One Trial (OT) framework is compared with current clinical development practices for treatments aimed at preserving insulin secretion in people with recent-onset type 1 diabetes
- Outcome
- Total development time
Methodological detailssingle master protocol, one continuously randomised population, one prospective statistical structure, uninterrupted follow-up
- Single master protocol
- One continuously randomised population
- One prospective statistical structure
- Uninterrupted follow-up
Main finding
As reported in the abstract
OT model could reduce total development time by approximately
45 months
Observational data: associations, not effects.
Original publication
It's All One Trial: a continuous master-protocol framework to accelerate development and confirmation of disease-modifying therapies for type 1 diabetes. Diabetologia. Published 12 November 2026. doi:10.
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