Characteristics and publication fate of unregistered and retrospectively registered clinical trials submitted to The BMJ over 4 years
Open accessAbstract
Objectives: We sought to evaluate the characteristics and publication fate of improperly registered clinical trials submitted to a medical journal (The BMJ) over a 4-year period to identify common types of registration issues and their relation to publication outcomes. Design: Research articles submitted to The BMJ and identified as unregistered or retrospectively registered by editors were included if they reported outcomes of a clinical trial. Relevant data regarding the trials were then extracted from each paper. Trials were categorised as prospectively registered, registered in an unapproved registry, unregistered or other, and explanations for registration deficiencies were grouped into six categories. We searched PubMed and Google to determine whether, where and when improperly registered studies were subsequently published and whether registration issues were disclosed. Results: 123 research papers reporting apparently unregistered or retrospectively registered clinical trials were identified. 110 studies (89.4%) were retrospectively registered, nine (7.3%) were unregistered, three (2.4%) had been registered in an unapproved registry and one study originally lacking registration details was later discovered to have been prospectively registered. 82 studies (66.6%) were funded entirely or in part by government sources, and only seven studies (5.7%) received funding from industry. Of those papers submitted to The BMJ through the end of 2015, 67 of the 70 papers rejected for registration problems (95.7%) were subsequently published in another journal. The registration problem was disclosed in only 2 (2.9%). Conclusions: Improper registration remains a problem, particularly for clinical trials that are government or foundation-funded. Nonetheless, improperly registered trials are almost always published, suggesting that medical journal editors may not actively enforce registration requirements.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Of the RCTs submitted for publication in the BMJ in 2013-2017, 89 were retrospectively registered and rejected as such but subsequently published in another journal.
“Of the RCTs submitted for publication in the BMJ in the period 2013-2017, 89 were retrospectively registered and rejected as such but subsequently published in another journal (Loder et al. 2018).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Loder et al. 2018
The Abstract Results report 110 retrospectively registered trials (89.4%), not 89 trials. They also report that 67 of 70 papers rejected for registration problems and submitted through 2015 were subsequently published elsewhere; that publication finding does not cover all 2013–2017 submissions or exclusively retrospectively registered trials. (LLM, conf=0.90)
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 Loder et al. 2018
The Results report that nine of 123 trials submitted to The BMJ with registration deficiencies (7.3%) were unregistered. That is not a rate among published medical trials: the study selected submissions with registration problems, and some were not published. The 77% oral-health figure is attributed to a different citation, not to Loder et al. (LLM, conf=0.88)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Chen, R., Desai, N. R., Ross, J. S., Zhang, W., Chau, K. H., Wayda, B., Murugiah, K., Lu, D. Y., Mittal, A., & Krumholz, H. M. (2016) · BMJ · doi:10.1136/bmj.i637 · Cited by 227 · see citing works
Flagged first, then by citations
Research works printed but not linked: 15
- [1]International Committee of Medical Journal Editors. Recommendations | Clinical trial registration. http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html (accessed 25 Aug 2017).
- [2]International Committee of Medical Journal Editors. Journals following the ICMJE recommendations. http://www.icmje.org/journals-following-the-icmje-recommendations/ (accessed 25 Aug 2017).
- [3]Zarin DA, Tse T, Williams RJ, et al Update on Trial Registration 11 Years after the ICMJE Policy Was Established. N Engl J Med 2017; 376: 383– 91. 10.1056/NEJMsr1601330 28121511 PMC5813248 · DOI
- [4]Hooft L, Korevaar DA, Molenaar N, et al Endorsement of ICMJE’s clinical trial registration policy: a survey among journal editors. Neth J Med 2014; 72: 349– 55. 25178768
- [5]Rayhill ML, Sharon R, Burch R, et al Registration status and outcome reporting of trials published in core headache medicine journals. Neurology 2015; 85: 1789– 94. 10.1212/WNL.0000000000002127 26475691 · DOI
- [7]Weber WE, Merino JG, Loder E Trial registration 10 years on. BMJ 2015; 351: h3572 10.1136/bmj.h3572 26149708 · DOI
- [8]Wager E, Williams P Project Overcome failure to Publish nEgative fiNdings Consortium. "Hardly worth the effort"? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study. BMJ 2013; 347: f5248 10.1136/bmj.f5248 24014339 PMC3805489 · DOI · Paper page
- [11]Harriman SL, Patel J When are clinical trials registered? An analysis of prospective versus retrospective registration. Trials 2016; 17: 187 10.1186/s13063-016-1310-8 27079379 PMC4832501 · DOI
- [12]International Committee of Medical Journal Editors. About ICMJE | Clinical trials registration. http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/ (accessed 25 Aug 2017).
- [13]Thomson-Reuters. 2016 Journal citation report. 2017 http://ipscience-help.thomsonreuters.com/incitesLive/JCRGroup/jcrOverview.html.
- [14]Dal-Ré R, Marušić A Prevention of selective outcome reporting: let us start from the beginning. Eur J Clin Pharmacol 2016; 72: 1283– 8. 10.1007/s00228-016-2112-3 27484242 · DOI
- [16]Phillips AT, Desai NR, Krumholz HM, et al Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017; 18: 333 10.1186/s13063-017-2068-3 28720112 PMC5516301 · DOI
- [18]Goldacre B, Lane S, Mahtani KR, et al Pharmaceutical companies' policies on access to trial data, results, and methods: audit study. BMJ 2017; 358: j3334 10.1136/bmj.j3334 28747301 · DOI
- [19]Dal-Ré R, Ross JS, Marušić A Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. J Clin Epidemiol 2016; 75: 100– 7. 10.1016/j.jclinepi.2016.01.017 26820559 · DOI · Paper page
- [21]Cole GD, Nowbar AN, Mielewczik M, et al Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study. BMJ 2015; 351: h4708 10.1136/bmj.h4708 26387520 PMC4575810 · DOI
Cited by
Sorted by citations
Nonpublication and Selective Outcome Reporting of Oral Health Trials
Diakonoff, H., Khalil, G., Jungo, S., Treluyer, J. M., Fron-Chabouis, H., & Smaïl-Faugeron, V. (2023) · Journal of Dental Research · doi:10.1177/00220345231158544 · Cited by 7 · see citing works
- Authors
- Loder, E., Loder, S., & Cook, S.
- Affiliations
- Brigham and Women's Faulkner Hospital (US)
- Columbia University (US)
- BMJ Group (United Kingdom) (GB)
- Corresponding author
- Loder, Stephen
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2018-02
- Volume
- 8
- Issue
- 2
- Pages
- e020037
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC5829901
- OpenAlex
- W2794138694
- Cited by
- 40
- References
- 1
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 8 · 2023: 3 · 2022: 6 · 2021: 5 · 2020: 4 · 2019: 2 · 2018: 4
- FWCI
- 5.33
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- clinical trial registration, retrospective registration, research funding sources, government-funded research, industry funding, clinical trial registries
- MeSH terms
- Clinical Trials as Topic, Humans, Periodicals as Topic, Prospective Studies, Publications, Registries, Retrospective Studies, Disclosure
About these checks
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.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
