You are here

Article Text

Article menu

Download PDFPDF

XML
Ethics
Original research
Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis
  1. Karolina Strzebonska1,
  2. Mateusz T Wasylewski1,
  3. Lucja Zaborowska1,
  4. Nico Riedel2,
  5. Susanne Wieschowski3,
  6. Daniel Strech2,4,
  7. Marcin Waligora1
  1. 1REMEDY, Research Ethics in Medicine Study Group, Department of Philosophy and Bioethics, Jagiellonian University Medical College, Krakow, Poland
  2. 2QUEST Center for Transforming Biomedical Research, Berlin Institute of Health, Berlin, Germany
  3. 3Institute for Ethics, History and Philosophy of Medicine, Hannover Medical School, Hannover, Germany
  4. 4Charité Universitätsmedizin Berlin, Berlin, Germany
  1. Correspondence to Dr Marcin Waligora; m.waligora{at}uj.edu.pl

Abstract

Objectives To establish the rates of publication and reporting of results for interventional clinical trials across Polish academic medical centres (AMCs) completed between 2009 and 2013. We aim also to compare the publication and reporting success between adult and paediatric trials.

Design Cross-sectional study.

Setting AMCs in Poland.

Participants AMCs with interventional trials registered on ClinicalTrials.gov.

Main outcome measure Results reporting on ClinicalTrials.gov and publishing via journal publication.

Results We identified 305 interventional clinical trials registered on ClinicalTrials.gov, completed between 2009 and 2013 and affiliated with at least one AMC. Overall, 243 of the 305 trials (79.7%) had been published as articles or posted their summary results on ClinicalTrials.gov. Results were posted within a year of study completion and/or published within 2 years of study completion for 131 trials (43.0%). Dissemination by both posting and publishing results in a timely manner was achieved by four trials (1.3%).

Conclusions Our cross-sectional analysis revealed that Polish AMCs fail to meet the expectation for timely disseminating the findings of all interventional clinical trials. Delayed dissemination and non-dissemination of trial results negatively affects decisions in healthcare.

  • medical ethics
  • health policy
  • clinical trials
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-034666

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Twitter @KStrzebonska, @m_waligora

    • Contributors MW, DS, SW developed the concept for the research study. NR retrieved trials and performed statistical analyses. KS, MTW, LZ performed the manual review. KS drafted the manuscript and was responsible for coordination of all aspects of the work. All the authors critically revised the manuscript for important intellectual content and approved the final manuscript.

    • Funding Funding was provided by the National Science Center, Poland UMO-2015/18/HS1/00354 (KS, MTW, MW).

    • Competing interests KS, MTW and MW were funded by Narodowe Centrum Nauki. DS and MW report personal fees from Advisory Bioethics Council, Sanofi outside the submitted work.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available in a public, open access repository. All datasheets with raw data are available on the Open Science Framework (https://osf.io/8xz29/). Additional data are available upon request.