A systematic review of clinical trial registration in major respiratory journals 2010–2018

Suntila, Nelli S M; Smith, Adam; Al-Dabbagh, Yusuf; Chalmers, James D.

doi:10.1183/13993003.01491-2018

Cited by 2 publications

(4 citation statements)

References 13 publications

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Section: Comparison With Other Studiessupporting

confidence: 88%

“…In terms of improvement over time the meta-regression model reported in the review suggested that the proportion of prospectively registered trials across a wide range of clinical specialties increased from 3% in 2009 to 21% in 2013 (18% increase, p = 0.04) [21]. Another systematic review of clinical trials published in major respiratory journals between 2010 and 2018 found an increase for prospective trial registration rates -from 75% in 2010 up to 100% in 2018 [22]. However, the group of published trials does not comprise all trials approved by an ethics committee and, therefore, the generalizability of these findings may still be limited.…”

Section: Introductionmentioning

confidence: 95%

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

Klatte

Sluka

Gloy

et al. 2023

BMC Med Res Methodol

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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.

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Section: Comparison With Other Studiessupporting

confidence: 88%

Section: Introductionmentioning

confidence: 95%

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

Klatte

Sluka

Gloy

et al. 2023

BMC Med Res Methodol

View full text Add to dashboard Cite

show abstract

“…In agreement with our results a systematic review on clinical registration in major respiratory journals reported that single center studies were more likely to be retrospectively registered or not registered. 19 An analysis of clinical trials approved in Switzerland from 2016 -2020 showed that more than half of the trials were monocentric trials. 34 Since awareness and regulatory control might also be less in monocentric trials, education and support of the registration and dissemination processes for all research facilities in Switzerland should be aspired.…”

Section: Comparison With Other Studiesmentioning

confidence: 99%

“…18 In agreement with these ndings a recent systematic review of clinical trials published in major respiratory journals between 2010 and 2018 found a positive trend for prospective trial registration -from 75% in 2010 up to 100% in 2018. 19 However, the group of published trials does not comprise all trials approved by an ethics committee and, therefore, the generalizability of these ndings is still limited. An international meta-research study of 326 RCT protocols approved in 2012 found that one in ve trials (70/326) remained unpublished at 10 years follow-up, and 21% of those unpublished trials (15/70) were not registered, i.e.…”

mentioning

confidence: 99%

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

Klatte

Sluka

Gloy

et al. 2022

Preprint

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Objective: The registration of clinical trials is required by law in Switzerland. We investigated (1) the proportion of pro- and retrospectively 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 371 (78%) were prospectively registered. While the percentages of registration and prospective registration of investigator-sponsored trials increased from 85% to 93% and from 70% to 81% over five 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.

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A systematic review of clinical trial registration in major respiratory journals 2010–2018

Cited by 2 publications

References 13 publications

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

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

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

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