An international academic research programme uniting clinicians, methodologists and patients to answer a question that matters.
Investigators from across the consortium reviewing recruitment and safety data at a coordination meeting.
BRAVE was conceived to address a persistent gap in the evidence base for a common but complex clinical condition. The consortium brings together academic centres with complementary expertise across four continents to design and deliver a definitive multi-centre programme.
The primary objective is to determine the comparative effectiveness of two evidence-based interventions on clinical outcomes at 24 months. Secondary objectives include safety, health-related quality of life, and cost-effectiveness across health systems.
A pragmatic, multi-centre, randomised controlled trial with adjudicated endpoints and pre-registered analysis plan. Recruitment is stratified across sites; endpoints are assessed by a blinded committee to eliminate bias.
Protocol development began in 2021, first patient enrolled in 2023, and primary results are expected in 2026 with follow-up data through 2028.
As of the most recent interim analysis, 3,412 participants have been enrolled across 86 sites in 24 countries. Recruitment remains on track to reach the target of 5,000 by end 2025.
Beyond primary results, BRAVE aims to establish a durable international research infrastructure for follow-on studies, real-world evidence, and translational sub-projects with patient partners embedded at every stage.
BRAVE is governed by an international Steering Committee, an independent Data Safety Monitoring Board, a Trial Management Group and a Patient & Public Involvement panel. All decisions are documented and published in accordance with the pre-registered protocol.
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Steering Committee
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DSMB
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Trial Management
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PPI Panel
