Biostatistical challenges in multicenter clinical trials: Best practices for collaboration and data harmonization across institutions

Multicentre orthopaedic clinical trials present distinct biostatistical and operational challenges that can affect the reliability and generalizability of their findings. Differences in site protocols, patient demographics, outcome measurements and regulatory environments contribute to data variability and complexity. This review discusses key strategies to address these issues, including the implementation of multilevel statistical models, development of uniform data collection tools and centralized processes for outcome assessment. Emphasis is placed on the value of early, coordinated planning and sustained collaboration among participating centers to ensure consistency and quality across sites. The review also explores the potential of digital technologies to streamline data integration and support harmonized workflows. By promoting methodological rigor and cross-institutional cooperation, these approaches aim to enhance the validity and impact of orthopaedic multicentre trial outcomes.