Evidence map›Paper›PMID 41393477›Full record

ArticleBioinformation2025

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

Deepankar Satapathy, Madhavi Eerike, Sanket Mishra, Sandip Dhole, U Rekha Priyadarshini, Bhagabati Prasad Dash, Debasis Bisoi

Abstract read
In one paragraph

Article in Bioinformation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Deepankar SatapathyDepartment of Orthopaedics, AIIMS, Bibinagar, Hyderabad, India.
Madhavi EerikeDepartment of Pharmacology, AIIMS, Bibinagar, Hyderabad, India.
Sanket MishraDepartment of Orthopaedics, IMS and SUM Hospital, Bhubaneswar, India.
Sandip DholeDepartment of Physical Medicine and Rehabilitation, AIIMS, Bibinagar, Hyderabad, India.
U Rekha PriyadarshiniDepartment of Pharmacology, AIIMS, Bibinagar, Hyderabad, India.
Bhagabati Prasad DashDepartment of Orthodontics, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Bhubaneswar, India.
Debasis BisoiDepartment of Pharmacology, AIIMS, Bibinagar, Hyderabad, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Artificial IntelligenceCloud-Based platformsCONSORT guidelinesdata standardizationemerging technologiesmobile health applicationsmulticentre orthopaedic trials

Identifiers

PMID41393477
PMCPMC12697442

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.