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Biostatistical challenges in multicenter clinical trials: Best practices for collaboration and data harmonization
Deepankar Satapathy1, Madhavi Eerike2, Sanket Mishra3
1Department of Orthopaedics, AIIMS, Bibinagar, Hyderabad, India.
Bioinformation
|December 15, 2025
Summary
Multicentre orthopaedic clinical trials face challenges affecting reliability. This review highlights strategies like multilevel models and collaboration to improve data quality and trial outcomes.
Area of Science:
- Orthopaedic surgery
- Clinical trial methodology
- Biostatistics
Background:
- Multicentre orthopaedic clinical trials face significant biostatistical and operational challenges.
- Variability in site protocols, patient demographics, outcome measures, and regulations impacts data reliability and generalizability.
Purpose of the Study:
- To review key strategies for addressing challenges in multicentre orthopaedic clinical trials.
- To enhance the reliability, generalizability, and impact of trial findings through methodological rigor and collaboration.
Main Methods:
- Implementation of multilevel statistical models.
- Development of uniform data collection tools and centralized outcome assessment.
- Leveraging digital technologies for data integration and harmonized workflows.
Main Results:
- Multilevel models can account for site-specific variations.
- Standardized tools and centralized processes improve data consistency.
- Digital technologies offer potential for streamlined data management.
Conclusions:
- Early, coordinated planning and sustained collaboration are crucial for multicentre trial success.
- Methodological rigor and cross-institutional cooperation enhance the validity of orthopaedic trial outcomes.
- Adopting advanced statistical and digital tools can improve the quality and impact of multicentre research.
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