Cited by 18Academic Publishing and Open AccessResearch Data Management PracticesMeta-analysis and systematic reviews

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study

Open access
DeVito, Nicholas J, Morley, Jessica, Smith, James Andrew, Drysdale, Henry, Goldacre, Ben, Heneghan, Carl·2024·BMJ Medicine

Abstract

Objective: To identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository. Design: Cross sectional audit study. Setting: EUCTR protocols and results sections, data extracted 1-3 December 2020. Population: Random sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018). Main outcome measures: Proportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route. Results: In the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1). Conclusions: EUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.

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.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1136/bmjmed-2023-000738

Cites

64 of 64 references verified0 citation errors · 0 not checkable

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.

A few free checks a day · papers already verified open instantly · results are public

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?

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

Flagged first, then by citations

1 of the 65 references couldn’t be matched to a known paper.

Research works printed but not linked: 5

  1. [5]European Commission. Commission guideline—guidance on posting and publication of result-related information on clinical trials in relation to the implementation of article 57(2) of regulation (EC) no 726/2004 and article 41(2) of regulation (EC) no 1901/2006. Official J Eur Union 2012; 55: 7– 10.
  2. [6]European Parliament and the Council of the European Union. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, directive 2001/20/EC, directive 2001/83/EC, and regulation (EC) no 726/2004. Official J Eur Union 2006; 49: 1– 19.
  3. [8]European Parliament and the Council of the European Union. Regulation (EC) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC. Official J Eur Union 2014; 57: 1– 76.
  4. [12]Clinical trials letters published. UK Parliament. 2019. Available: https://old.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/news-parliament-2017/clinical-trials-letters-published-2019/ [Accessed 25 Feb 2022].
  5. [65]Lefebvre C, Glanville J, Briscoe S, et al. Chapter 4: searching for and selecting studies. Cochrane Handbook for Systematic Reviews of Interventions Wiley-Blackwell 2021. Available: https://training.cochrane.org/handbook/current/chapter-04

Cited by

Sorted by citations

Authors
DeVito, N. J., Morley, J., Smith, J. A., Drysdale, H., Goldacre, B., & Heneghan, C.
Affiliations
  • University of Oxford (GB)
  • Nuffield Orthopaedic Centre (GB)
Corresponding author
DeVito, Nicholas J
Venue
BMJ Medicine
Publisher
BMJ
Published
2024-01
Volume
3
Issue
1
Pages
e000738
ISSN
2754-0413 (ISSN-L)
OpenAlex
W4390817849
Cited by
18
References
65
Citations by year
2026: 3 · 2025: 11 · 2024: 4
FWCI
6.72
Type
journal article
Language
en
Open access
Locations
  • BMJ Medicine (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • Good Thinking Society (N/A)
  • Naji Foundation (N/A)
Topics
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
ClinicalTrials.gov, journal publishing, time to result, research waste

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