Evidence map›Paper›PMID 41882735›Full record

ArticleTrials2026

Supporting reanalysis and reuse of clinical trial data: a case study.

Cora Burgwinkel, Han Chang Chiam, Ka Hin Tai, Jifan Wang, Mian Haider Ali, Salman Soleiman Fallah, Minoo Matbouriahi, Tobechi Obinwanne, Grigorios Papapostolou, Muhammad Riedha and 5 more

Abstract read
In one paragraph

Article in Trials, 2026. 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

15 authors.

Cora Burgwinkel *Epidemiology, Biostatistics and Prevention Institute (EBPI) and Center for Reproducible Science and Research Synthesis (CRS), University of Zurich, Zurich, Switzerland.
Han Chang Chiam *Center for Medical Data Science, Medical University of Vienna, Vienna, Austria.
Ka Hin Tai *Univ Rennes, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Rennes, France.
Jifan Wang *Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Mian Haider AliThe Institute for Medical Information Processing, Biometry, and Epidemiology, Medical Faculty, Ludwig-Maximilians University Munich, Munich, Germany.
Salman Soleiman FallahDepartment of Medical Informatics, University Medical Center Göttingen, Göttingen, Germany.
Minoo MatbouriahiDepartment of General Psychology, University of Padova, Padova, Italy.
Tobechi ObinwanneDepartment of Medical Informatics, University Medical Center Göttingen, Göttingen, Germany.
Grigorios PapapostolouMedical Informatics Group, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany.
Muhammad RiedhaHospices Civils de Lyon, Public Health Department, Clinical Epidemiology Research, University of Lyon, Claude Bernard University Lyon 1, Interdisciplinary Doctoral School of Health Sciences (EDISS), Lyon, France.
Giulia VarvaraUniv Rennes, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Rennes, France.
Yazid ZalaiQUEST Center - Berlin Institute of Health at Charité, Berlin, Germany.
Ulrich Mansmann *The Institute for Medical Information Processing, Biometry, and Epidemiology, Medical Faculty, Ludwig-Maximilians University Munich, Munich, Germany.
Ulrich Sax *Department of Medical Informatics, University Medical Center Göttingen, Göttingen, Germany.
Leonhard Held *Epidemiology, Biostatistics and Prevention Institute (EBPI) and Center for Reproducible Science and Research Synthesis (CRS), University of Zurich, Zurich, Switzerland. leonhard.held@uzh.ch.

Funding

HORIZON EUROPE Marie Sklodowska-Curie Actions 101120360Swiss State Secretary for Education, Research and Innovation 23.00303
6 · The paper itself

Abstract

backgroundReproducing published findings from clinical trials is a critical component of scientific transparency, yet it remains a challenging and under-practiced task. Despite increasing emphasis on reproducibility and data reuse in research policies, only few real-world examples exist where several teams have reproduced complex analyses using clinical trial data. In this case study, the aim was to reproduce the key findings of a high-impact clinical trial on rectal cancer treatment using shared trial data.

methodWe organized a multi-team datathon, where each team was provided with the same dataset and supporting material, and was tasked to reproduce the results of the CAO/ARO/AIO-04 trial, with optional additional analyses. We contacted the original investigators for access and reuse of the data, as well as information on the clinical and scientific aspects of the study.

resultsFive teams used R or Python to reproduce the statistical results, and the corresponding scripts can be found on Gitlab. The key findings on disease-free survival (DFS) were consistently reproduced by most teams, reinforcing confidence in the main trial conclusions. Result robustness was investigated using different analytical software or statistical models. Some challenges were encountered because supplementary material of the original study was not easily found. Minor reporting issues were also identified in the reproduced paper.

conclusionsReproduction of a major oncology clinical trial confirmed the reliability of its main conclusions. Divergences highlighted reporting gaps-such as incomplete protocols and broken links-that future trials should address. This case study demonstrates the value of systematic reproducibility checks for the transparency of clinical research and the challenges in data sharing for reproducibility.

Indexed as

Clinical Trials as TopicInformation DisseminationRectal NeoplasmsResearch DesignDisease-Free SurvivalHumansReproducibility of ResultsSecondary Data AnalysisData sharingDatathonMulti-team analysisReproducibilityTransparency

Identifiers

PMID41882735
PMCPMC13137473

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.