Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis
Open accessAbstract
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1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up.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 One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered.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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Our high rate of nonpublication in oral health (56.7%) is probably underestimated.
“This means nonpublication is more frequent in unregistered trials, and our high rate of nonpublication in oral health (56.7%) is probably underestimated.”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
The Results and Discussion (Comparison with other studies; page not available) show that unregistered trials were more common among unpublished than published RCTs, supporting the premise of the citing sentence. The source does not study oral-health trials or establish that the citing authors’ 56.7% nonpublication estimate is an underestimate; that is their inference from the source’s finding. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn 2014, 77% of published oral health RCTs were not registered in a public registry, compared to 6% to 7% in medicine.
“In our previous study published in 2014, we found that 77% of published oral health RCTs were not registered in a public registry (Smaïl-Faugeron and Esposito 2014), compared to 6% to 7% in medicine (Loder et al. 2018; Speich et al. 2022).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
The Results report that 6% of all 326 RCTs approved by research ethics committees were unregistered, supporting the lower end of the comparison. But only 2% of the published RCTs in this sample were unregistered; the paper does not establish a 6%–7% rate for published medical RCTs. The 77% oral-health figure is attributed to a different citation, not to Speich et al. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn medicine, only 2% of published randomized trials were not registered, while 21% of nonpublished trials were not registered.
“In medicine, only 2% of published randomized trials were not registered, while 21% of nonpublished trials were not registered (Speich et al. 2022).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
The Results report that 4 of 256 published RCTs (2%) and 15 of 70 unpublished RCTs (21%) were unregistered. The figures come from this study’s sample of trials approved by research ethics committees in four countries, not from all randomized trials in medicine; the claim omits that scope limitation. (LLM, conf=0.82)
Experimental — accuracy not yet measuredLesser trial discontinuation in oral health may be explained by smaller sample sizes.
“In this aspect, lesser trial discontinuation in oral health may be explained by smaller sample sizes (median 53 in our oral health registered RCTs and 250 in medical RCTs) (Speich et al. 2022).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
In medicine, trial discontinuation reached 30%.
“In medicine, trial discontinuation reached 30%.”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
Nonpublication is more frequent in unregistered trials.
“This means nonpublication is more frequent in unregistered trials, and our high rate of nonpublication in oral health (56.7%) is probably underestimated.”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
It seems 20% to 50% of medical trials remain unpublished.
“It seems 20% to 50% of medical trials remain unpublished (Jones et al. 2013; Speich et al. 2022).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
Nonpublication in dentistry seems to be higher than in medicine.
“Nonpublication in dentistry seems to be higher than in medicine.”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Speich et al. 2022
The Results report that 79% of the studied RCTs were published after 10 years, and the Discussion says nonpublication remains common. Neither section compares dentistry with medicine; searches for dental trials and a specialty-specific publication comparison found no such passage in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredA high proportion of clinical trials remain unpublished.
“However, a high proportion of clinical trials remain unpublished.112 113”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [113]
Meta-research studies found more than a quarter of unpublished trials in various countries had results available in trial registries, and some data (particularly harms) were more completely reported in registries than in journal publications.
“Meta-research studies have found that more than a quarter of unpublished trials in various countries had results available in trial registries, and some data (particularly harms) were more completely reported in registries than in journal publications.113 124 125 126 127”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [113]
Publication of trial results was associated with higher quality reporting in the protocol.
“Also, publication of trial results was associated with higher quality reporting in the protocol.113”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [113]
In a sample of 326 protocols approved in 2012, 70 (21%) trials remained unpublished after 10 years.
“In a sample of 326 protocols approved in 2012, 70 (21%) trials remained unpublished after 10 years.113”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [113]
23 of 147 investigator sponsored trials (16%) reported their results in a trial registry, compared with 150 of 179 industry sponsored trials (84%).
“Twenty three of 147 investigator sponsored trials (16%) reported their results in a trial registry in contrast with 150 of 179 industry sponsored trials (84%).”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [113]
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- Authors
- Speich, B., Gryaznov, D., Busse, J. W., Gloy, V. L., Lohner, S., Klatte, K., Taji Heravi, A., Ghosh, N., Lee, H., Mansouri, A., Marian, I. R., Saccilotto, R., Nury, E., Kasenda, B., Ojeda–Ruiz, E., Schandelmaier, S., Tomonaga, Y., Amstutz, A., Pauli–Magnus, C., Bischoff, K., Wollmann, K., Rehner, L., Meerpohl, J. J., Nordmann, A., Wong, J., Chow, N., Hong, P. J., Mc Cord – De Iaco, K., Sricharoenchai, S., Agarwal, A., Schwenkglenks, M., Hemkens, L. G., von Elm, E., Copsey, B., Griessbach, A. N., Schönenberger, C., Mertz, D., Blümle, A., von Niederhäusern, B., Hopewell, S., Odutayo, A., & Briel, M.
- Affiliations
- University of Basel (CH)
- McMaster University (CA)
- University of Pecs (HU)
- University of Oxford (GB)
- University of Freiburg (DE)
- University of Zurich (CH)
- Swiss Tropical and Public Health Institute (CH)
- Cochrane Deutschland Stiftung (DE)
- University of Toronto (CA)
- St. Michael's Hospital (CA)
- Corresponding author
- Speich, Benjamin
- ORCID
- Speich, Benjamin
- Gryaznov, Dmitry
- Busse, Jason W.
- Gloy, Viktoria L.
- Lohner, Szimonetta
- Taji Heravi, Ala
- Ghosh, Nilabh
- Lee, Hopin
- Mansouri, Anita
- Marian, Ioana R.
- Saccilotto, Ramon
- Nury, Edris
- Kasenda, Benjamin
- Ojeda–Ruiz, Elena
- Schandelmaier, Stefan
- Tomonaga, Yuki
- Amstutz, Alain
- Bischoff, Karin
- Wollmann, Katharina
- Rehner, Laura
- Meerpohl, Joerg J.
- Wong, Jacqueline
- Chow, Ngai
- Mc Cord – De Iaco, Kimberly
- Sricharoenchai, Sirintip
- Agarwal, Arnav
- Schwenkglenks, Matthias
- Hemkens, Lars G.
- von Elm, Erik
- Copsey, Bethan
- Griessbach, Alexandra N.
- Schönenberger, Christof
- Mertz, Dominik
- Blümle, Anette
- Hopewell, Sally
- Odutayo, Ayodele
- Briel, Matthias
- Venue
- PLOS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2022-04-27
- Volume
- 19
- Issue
- 4
- Pages
- e1003980
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC9094518
- OpenAlex
- W4225109369
- Cited by
- 69
- References
- 27
- Citations by year
- 2026: 14 · 2025: 24 · 2024: 11 · 2023: 12 · 2022: 8
- FWCI
- 8.58
- Type
- journal article
- Language
- en
- Update notices
- new_version (2022-05-11)
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Explore Bristol Research (publishedVersion, cc-by)
- Bristol Research (University of Bristol) (publishedVersion, cc-by)
- SERVAL (Université de Lausanne) (publishedVersion, cc-by)
- edoc (University of Basel) (acceptedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Repository of the Academy's Library (Library of the Hungarian Academy of Sciences) (acceptedVersion)
- IRIS (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by)
- Funders
- Swiss Federal Office of Publich Health
- Swiss National Science Foundation (P300PB_177933 and P4P4PM_194496)
- Research Foundation of the University of Basel
- NIHR Pre-Doctoral Fellowship
- Alexander von Humboldt-Stiftung
- János Bolyai Research Scholarship of the Hungarian Academy of Sciences (BO/00498/17/5)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- randomized controlled trials, clinical trial registration, trial discontinuation, publication bias, clinical trial registries, SPIRIT checklist, industry-sponsored trials, trial completion, research ethics committee approval, ClinicalTrials.gov, International Clinical Trials Registry Platform
- MeSH terms
- Germany, Humans, Registries, Research Personnel, Odds Ratio, Randomized Controlled Trials as Topic
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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