Reliability of Trial Information Across Registries for Trials With Multiple Registrations

Speich, Benjamin; Gloy, Viktoria; Klatte, Katharina; Gryaznov, Dmitry; Heravi, Ala Taji; Ghosh, Nilabh; Marian, Ioana R; Lee, Hopin; Mansouri, Anita; Lohner, Szimonetta; Saccilotto, Ramon; Chan, An‐Wen; Blümle, Anette; Odutayo, Ayodele; Hopewell, Sally; Briel, Matthias; Niederhäusern, Belinda von; Kasenda, Benjamin; Ojeda-Ruiz, Elena; Schandelmaier, Stefan; Mertz, Dominik; Tomonaga, Yuki; Amstutz, Alain; Pauli‐Magnus, Christiane; Sluka, Constantin; Bischoff, Karin; Wollmann, Katharina; Rehner, Laura; Meerpohl, Joerg J; Nordmann, Alain; Wong, Jacqueline; Chow, Ngai; Hong, Patrick Jiho; Cord, Kimberly Mc; Sricharoenchai, Sirintip; Busse, Jason W.; Agarwal, Arnav; Schwenkglenks, Matthias; Moffa, Giusi; Hemkens, Lars G.; Elm, Erik von

doi:10.1001/jamanetworkopen.2021.28898

Cited by 13 publications

(12 citation statements)

References 23 publications

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“…Future research should assess if the rate of discontinued trials due to poor recruitment can be reduced with pilot or feasibility studies [ 18 ]. As stated by clinical trial registry representatives, trial registration and prospective trial registration should be enforced by publishing journals (including checking if trial registration exists) [ 32 ]. In case a trial was not prospectively registered, authors should at least explain in the published article why this was not done.…”

Section: Discussionmentioning

confidence: 99%

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

et al. 2022

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Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. Conclusions We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.

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Section: Discussionmentioning

confidence: 99%

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

et al. 2022

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“…The data presented is only as good as the data acquired from the registries; the ICTRP gathers records from 17 different trial registries collecting information from all around the world. Despite its importance, there are still chances to improve the consistency and quality of the data provided( 30 , 31 , 32 ). Trials’ protocols provide much more information and details on the methodology and primary outcome.…”

Section: Discussionmentioning

confidence: 99%

A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform

Fawzy

Shaar

Taha

et al. 2023

Clinical Microbiology and Infection

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“…The study is limited by data quality in several ways. Entries for the same trial have been found to be inconsistent across different registries [62]. We relied on the bridging flag variable in the ICTRP export to identify trials cross-registered on other registries for the purpose of determining whether the trial was prospectively registered anywhere; however, it is likely that the bridging flag is incomplete because other trial registrations are not generally well reported in registrations.…”

Section: Discussionmentioning

confidence: 99%

Estimating the effect of COVID-19 on trial design characteristics: a registered report

et al. 2023

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There have been reports of poor-quality research during the COVID-19 pandemic. This registered report assessed design characteristics of registered clinical trials for COVID-19 compared to non-COVID-19 trials to empirically explore the design of clinical research during a pandemic and how it compares to research conducted in non-pandemic times. We did a retrospective cohort study with a 1 : 1 ratio of interventional COVID-19 registrations to non-COVID-19 registrations, with four trial design outcomes: use of control arm, randomization, blinding and prospective registration. Logistic regression was used to estimate the odds ratio of investigating COVID-19 versus not COVID-19 and estimate direct and total effects of investigating COVID-19 for each outcome. The primary analysis showed a positive direct and total effect of COVID-19 on the use of control arms and randomization. It showed a negative direct effect of COVID-19 on blinding but no evidence of a total effect. There was no evidence of an effect on prospective registration. Taken together with secondary and sensitivity analyses, our findings are inconclusive but point towards a higher prevalence of key design characteristics in COVID-19 trials versus controls. The findings do not support much existing COVID-19 research quality literature, which generally suggests that COVID-19 led to a reduction in quality. Limitations included some data quality issues, minor deviations from the pre-registered plan and the fact that trial registrations were analysed which may not accurately reflect study design and conduct. Following in-principle acceptance, the approved stage 1 version of this manuscript was pre-registered on the Open Science Framework at https://doi.org/10.17605/OSF.IO/5YAEB . This pre-registration was performed prior to data analysis.

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Reliability of Trial Information Across Registries for Trials With Multiple Registrations

Cited by 13 publications

References 23 publications

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform

Estimating the effect of COVID-19 on trial design characteristics: a registered report

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