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2026 · Article · npj Digital Medicine

An automated approach to improve clinical trial registration and to identify outcome changes on ClinicalTrials.gov

Xiangji Ying; Kiran Ninan; Jean-Pierre Oberste; Colby J. Vorland; Tianjing Li; Andrew W. Brown; Joe D. Menke; Riaz Qureshi; Nicholas J. DeVito; Matthew J. Page; Joanne E. McKenzie; Ian J. Saldanha; Sirui Zhang; Nancy J. Butcher; Martin Offringa; Jamie Cummins; Halil Kilicoglu; Evan Mayo-Wilson

Evaluates an LLM-assisted method for detecting incomplete outcome definitions and outcome changes on ClinicalTrials.gov.

Open-science resources

Resource verification & source notes
  • Model outputs: Live public OSF file inventory contains: Model output.zip. This verifies shared model outputs, not access to every original input or executable analysis script.
  • Prompts: Live public OSF file inventory contains: Prompts for assessing outcome definition completeness and detecting outcome changes_Nov142025.docx.
  • Registration: OSF API identifies this as a public registration, registered None; not merely an editable project. Open-Ended Registration schema, registered_from 2tyh3; nonwithdrawn. OpenAlex had incorrectly classified this as a research project.
  • Earlier preprint: Saved catalogue version matching based on title, ordered byline, and study content; prior manuscript DOI retained.
  • Free full text: OpenAlex marks this location open access (gold); availability is metadata-reported, not an independently tested reusable license.

Publication details

Research themes

Research toolsReporting transparency

Clinical trials · Large language models

Author affiliations & identifiers
  • Xiangji Ying: Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA
  • Kiran Ninan: Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA · ORCID https://orcid.org/0000-0002-8085-6751
  • Jean-Pierre Oberste: Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA
  • Colby J. Vorland: Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA
  • Tianjing Li: Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
  • Andrew W. Brown: Arkansas Children’s Research Institute, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA
  • Joe D. Menke: School of Information Sciences, University of Illinois at Urbana-Champaign, Champaign, IL, USA
  • Riaz Qureshi: Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
  • Nicholas J. DeVito: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  • Matthew J. Page: Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia
  • Joanne E. McKenzie: Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia
  • Ian J. Saldanha: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
  • Sirui Zhang: Department of Epidemiology, School of Public Health, Brown University, Providence, RI, USA
  • Nancy J. Butcher: Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada
  • Martin Offringa: Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada
  • Jamie Cummins: Department for the Psychology of Digitalisation, University of Bern, Bern, Switzerland; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  • Halil Kilicoglu: School of Information Sciences, University of Illinois at Urbana-Champaign, Champaign, IL, USA
  • Evan Mayo-Wilson: Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA

Versions & associated materials

These items belong to this research work. Their individual titles, author lists, and source identifiers are preserved below.

GPT's Performance in Identifying Outcome Changes on ClinicalTrials.gov

Preprint · 2024 · OSF.io [Protocol].

Xiangji Ying; Colby J. Vorland; Riaz Qureshi; Andrew William Brown; Halil Kilicoglu; Ian Saldanha; Nicholas J DeVito; Evan Mayo-Wilson

DOI: 10.31222/osf.io/npvwr

GPT's Performance in Identifying Outcome Changes on ClinicalTrials.gov

Registration · 2024 · OSF Preprints (OSF Preprints)

Brown, Andrew W.; DeVito, Nicholas J; Qureshi, Riaz; Saldanha, Ian; Vorland, Colby J.; Ying, Xiangji; Mayo-Wilson, Evan; Kilicoglu, Halil

DOI: 10.17605/osf.io/xqrb3

Using GPT to Identify Changes in Clinical Trial Outcomes Registered on ClinicalTrials.gov

Oral Abstract · 2025 · International Congress on Peer Review and Scientific Publication, Chicago

Xiangji Ying; Colby J. Vorland; Kiran Ninan; Jean-Pierre Oberste; Andrew W. Brown; Riaz Qureshi; Sirui Zhang; Nicholas J. DeVito; Matthew Page; Ian J. Saldanha; Halil Kilicoglu; Evan Mayo-Wilson

Preprint & version links

Related materials

Metadata sources: OpenAlex, Google Scholar, CV. Classification is an editorial interpretation of the title, abstract, and supplied CV.