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. 2023 Jan 27;23(1):27.
doi: 10.1186/s12874-023-01840-9.

Towards full clinical trial registration and results publication: longitudinal meta-research study in Northwestern and Central Switzerland

Katharina Klatte  1 , Constantin Sluka  2 , Viktoria Gloy  2 , Ala Taji Heravi  2 , Christof Schönenberger  2 , Nienke Jones  3 , Elena Brunnschweiler  3 , Christiane Pauli-Magnus #  2 , Matthias Briel #  2   4
Affiliations

Towards full clinical trial registration and results publication: longitudinal meta-research study in Northwestern and Central Switzerland

Katharina Klatte et al. BMC Med Res Methodol. .

Abstract

Objective: The registration of clinical trials is required by law in Switzerland. We investigated (1) the proportion of registered and prospectively registered clinical trials, (2) the availability of results for ethically approved trial protocols, (3) factors associated with increased registration, and (4) reasons for non-registration.

Design and setting: We included all clinical trials with mandatory prospective registration, which were approved by the ethics committee of Northwestern and Central Switzerland between January 1, 2016, and December 31, 2020.

Methods: We extracted relevant trial characteristics from the Swiss Business Administration System for Ethics Committees and systematically searched the International Clinical Trials Registry Platform and primary trial registries for corresponding registry entries. We used multivariable logistic regression to examine the association between trial characteristics and registration. We qualitatively assessed reasons for non-registration of trials through an email questionnaire for trial investigators.

Results: Of 473 included clinical trials, 432 (91%) were registered at all and 326 (69%) were prospectively registered. While the percentages of registration and prospective registration of investigator-sponsored trials increased from 85 to 93% and from 59 to 70% over 5 years, respectively, industry-sponsored trials consistently remained at a high level of prospective registration (92 to 100%). Trials with multiple centres, higher risk category, or methodological support from the local clinical trials unit were independently associated with increased registration rates. Of 103 clinical trials completed before August 2020, results were available for 70% of industry-sponsored trials and 45% of investigator-sponsored trials as peer-reviewed journal publications or in trial registries. Most common reasons for non-registration provided by investigators were lack of time or resources (53%), lack of knowledge (22%), and lack of reminders by the ethics committee (36%).

Conclusions: In Northwestern and Central Switzerland about 10% of clinical trials remained unregistered despite the obligation by law. More support for investigators and stricter enforcement by regulators are needed to improve the transparency of investigator-sponsored trials in particular.

Keywords: Legal obligation; Non-registration reasons; Randomized controlled trials; Switzerland; Trial registration.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Percentage of clinical intervention studies registered and prospectively registered from 2016 to 2020 stratified by sponsorship. Panel A: Investigator-sponsored studies, Panel B: Industry-sponsored studies
See this image and copyright information in PMC

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