gms | German Medical Science

Klasse statt Masse – wider die wertlose Wissenschaft: 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

09.03. - 11.03.2017, Hamburg

Discontinuation and Publication of Randomized Clinical Trials supported by the Main Public Funding Body in Switzerland: a Retrospective Cohort Study

Meeting Abstract

  • corresponding author presenting/speaker Alain Amstutz - ceb - Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Schweiz
  • author Stefan Schandelmaier - Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Kanada
  • author Belinda von Niederhäusern - Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, Basel, Schweiz
  • author Erik von Elm - Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Schweiz
  • author Matthias Briel - ceb - Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Schweiz

Klasse statt Masse – wider die wertlose Wissenschaft. 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Hamburg, 09.-11.03.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. Doc17ebmV44

doi: 10.3205/17ebm047, urn:nbn:de:0183-17ebm0475

Published: February 23, 2017

© 2017 Amstutz et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background: The Swiss National Science Foundation (SNSF), the main public funding body for research in Switzerland, promotes academic excellence through competitive selection of study proposals and rigorous evaluation of feasibility. Completion status and publication history of SNSF-supported studies have not been investigated before.

Objectives: To assess completion and publication status of all human health care RCTs supported by the SNSF.

Methods: We established a retrospective cohort of all SNSF-supported RCTs for which recruitment and funding had ended in 2015 or earlier. Two investigators independently searched corresponding publications in electronic databases. We approached all principal investigators for additional publications and information about trial discontinuation. Teams of two investigators independently extracted study characteristics from the original proposal and, if available, from trial registries and publications. We used multivariable regression for a risk factor analysis.

Findings: We included 101 RCTs supported by the SNSF between 1986 and 2015. Eighty-seven (86%) principal investigators responded to our survey. Overall, 69 (68%) RCTs were completed, 26 (26%) RCTs were prematurely discontinued (all due to slow recruitment), and the completion status remained unclear for 6 (6%) RCTs. For analyzing publication status, we excluded 4 RCTs for which follow-up was still ongoing and 9 for which manuscripts were still in preparation. Of the remaining 88 RCTs, 53 (60%) were published as full articles in peer-reviewed journals. Multivariable regression models suggested that discontinued trials were at higher risk for non-publication than completed trials (adjusted OR 7.61, 95% CI, 2.44-27.09). Compared to other Swiss RCTs, the risk of discontinuation for SNSF-supported RCTs was higher than in industry-initiated RCTs (adjusted OR 3.84, 95% CI 1.68-8.74) but not significantly different from investigator-initiated RCTs not supported by the SNSF (adjusted OR 1.05, 95% CI, 0.51-2.11). We found no evidence that the proportion of discontinued or unpublished RCTs decreased over the last 20 years.

Interpretation: One fourth of SNSF-supported RCTs were prematurely discontinued due to slow recruitment, 40% of all included RCTs and 70% of all discontinued RCTs were not published in peer-reviewed journals. There is a case to reconsider how public funding bodies such as the SNSF could improve their feasibility assessment and promote publication of RCTs irrespective of completion status.


References

1.
Kasenda B, von Elm E, You J, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014;311(10):1045-51. DOI: 10.1001/jama.2014.1361 External link