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Bild på Shai Mulinari. Privat bild.

Shai Mulinari

Docent | Universitetslektor

Bild på Shai Mulinari. Privat bild.

Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed

Författare

  • Gustav Nilsonne
  • Susanne Wieschowski
  • Nicholas J DeVito
  • Maia Salholz-Hillel
  • Love Ahnström
  • Till Bruckner
  • Katarzyna Klas
  • Tarik Suljic
  • Samruddhi Yerunkar
  • Natasha Olsson
  • Carolina Cruz
  • Karolina Strzebonska
  • Lars Småbrekke
  • Mateusz T Wasylewski
  • Johan Bengtsson
  • Martin Ringsten
  • Aminul Schuster
  • Tomasz Krawczyk
  • Themistoklis Paraskevas
  • Eero Raittio
  • Luca Herczeg
  • Jan-Ole Hesselberg
  • Sofia Karlsson
  • Ronak Borana
  • Matteo Bruschettini
  • Shai Mulinari
  • Karely Lizárraga
  • Maximilian Siebert
  • Nicole Hildebrand
  • Shreya Ramakrishnan
  • Perrine Janiaud
  • Emmanuel Zavalis
  • Delwen Franzen
  • Kim Boesen
  • Lars G Hemkens
  • Florian Naudet
  • Sofie Possmark
  • Rebecca M Willén
  • John P Ioannidis
  • Daniel Strech
  • Cathrine Axfors
Visa allt

Summary, in English

OBJECTIVE: To systematically evaluate timely reporting of clinical trial results at medical universities and university hospitals in the Nordic countries.

STUDY DESIGN AND SETTING: In this cross-sectional study, we included trials (regardless of intervention) registered in the EU Clinical Trials Registry and/or ClinicalTrials.gov, completed 2016-2019, and led by a university with medical faculty or university hospital in Denmark, Finland, Iceland, Norway, or Sweden. We identified summary results posted at the trial registries, and conducted systematic manual searches for results publications (e.g., journal articles, preprints). We present proportions with 95% confidence intervals (CI), and medians with interquartile range (IQR).

PROTOCOL: https://osf.io/wua3r RESULTS: Among 2,112 included clinical trials, 1,650 (78.1%, 95%CI 76.3-79.8%) reported any results during our follow-up; 1,097 (51.9%, 95%CI 49.8-54.1%) reported any results within 2 years of the global completion date; and 48 (2.3%, 95%CI 1.7-3.0%) posted summary results in the registry within 1 year. Median time from global completion date to results reporting was 690 days (IQR 1,103). 856/1,681 (50.9%) of ClinicalTrials.gov-registrations were prospective. Denmark contributed approximately half of all trials. Reporting performance varied widely between institutions.

CONCLUSION: Missing and delayed results reporting of academically led clinical trials is a pervasive problem in the Nordic countries. We relied on trial registry information, which can be incomplete. Institutions, funders, and policy makers need to support trial teams, ensure regulation adherence, and secure trial reporting before results are permanently lost.

Avdelning/ar

  • Pediatrik, Lund
  • Kansli för kliniska vetenskaper, Lund
  • Sociologiska institutionen

Publiceringsår

2025-02-01

Språk

Engelska

Publikation/Tidskrift/Serie

Journal of Clinical Epidemiology

Volym

181

Dokumenttyp

Artikel i tidskrift

Förlag

Elsevier

Ämne

  • Health Care Service and Management, Health Policy and Services and Health Economy

Aktiv

Published

ISBN/ISSN/Övrigt

  • ISSN: 0895-4356