OxMaR: open source free software for online minimization and randomization for clinical trials

Area of Science:

• Clinical Trials Methodology
• Biostatistics
• Health Informatics

Background:

• Minimization is a participant allocation method that reduces baseline characteristic imbalances between study arms.
• Traditional minimization requires real-time computational analysis, posing challenges for multi-site studies.
• Existing free, open-source software for minimization is lacking, hindering its widespread adoption.

Purpose of the Study:

• To develop and introduce OxMaR, a free, web-based software for implementing minimization in clinical studies.
• To provide a user-friendly, accessible tool for participant allocation that can be used across multiple study sites and devices.
• To overcome the logistical barriers of minimization, enabling its use in smaller and low-resource research settings.

Main Methods:

• OxMaR is a self-contained software requiring no special installations, accessible via the internet.
• It performs real-time assessment of participant characteristics for allocation.
• The system provides real-time allocation information and distributed backups, and is customizable.

Main Results:

• OxMaR enables researchers to implement minimization from any location using internet-connected devices.
• The software is low-cost or free to use, requiring minimal setup.
• It has been successfully tested and utilized in a low-budget, multi-center study, demonstrating its practicality.

Conclusions:

• OxMaR addresses the need for accessible minimization software, facilitating better-matched study arms.
• The tool is particularly valuable for multi-site, low-budget, and low-resource clinical studies.
• OxMaR promotes wider adoption of minimization, potentially improving the quality of clinical research evidence.