Title

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

Authors

Deepankar Satapathy¹, Madhavi Eerike², Sanket Mishra³, Sandip Dhole⁴, U. Rekha Priyadarshini², Bhagabati Prasad Dash⁵ & Debasis Bisoi^2,*

Affiliation

¹Department of Orthopaedics, AIIMS, Bibinagar, Hyderabad, India; ²Department of Pharmacology, AIIMS, Bibinagar, Hyderabad, India; ³Department of Orthopaedics, IMS and SUM Hospital, Bhubaneswar, India; ⁴Department of Physical Medicine and Rehabilitation, AIIMS, Bibinagar, Hyderabad, India; ⁵Department of Orthodontics, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Bhubaneswar, India; *Corresponding author

Email

Deepankar Satapathy - E-mail: dipun86@gmail.com
Madhavi Eerike - E-mail: dr.madhavieerike@gmail.com
Sanket Mishra - E-mail: sanket.mishra@gmail.com
Sandip Dhole - E-mail: drsandipdhole@gmail.com
U. Rekha Priyadarshini - E-mail: rekha19dr@gmail.com
Bhagabati Prasad Dash - E-mail: bhagabati.dash@kids.ac.in
Debasis Bisoi - E-mail: bisoidebasis@gmail.com

Article Type

Research Article

Date

Received August 1, 2025; Revised August 31, 2025; Accepted August 31, 2025, Published August 31, 2025

Abstract

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.

Keywords

Artificial Intelligence, Cloud-Based platforms, CONSORT guidelines, data standardization, emerging technologies, mobile health applications, multicentre orthopaedic trials

Citation

Satapathy et al. Bioinformation 21(8): 2935-2941 (2025)

Edited by

Ritik Kashwani

ISSN

0973-2063

Publisher

Biomedical Informatics

License

This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. This is distributed under the terms of the Creative Commons Attribution License.