Evidence map›Paper›PMID 40899933›Full record

SynthesisJAMA network open2025

Nonregistration, Discontinuation, and Nonpublication of Randomized Trials: A Systematic Review.

Benjamin Speich, Ala Taji Heravi, Christof M Schönenberger, Lena Hausheer, Dmitry Gryaznov, Jason W Busse, Manuela Covino, Szimonetta Lohner, Malena Chiaborelli, Johannes M Schwenke and 17 more

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in JAMA network open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Benjamin SpeichDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Ala Taji HeraviDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Christof M SchönenbergerDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Lena HausheerDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Dmitry GryaznovDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Jason W BusseDepartment of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
Manuela CovinoDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Szimonetta LohnerMTA-PTE Lendület "Momentum" Evidence in Medicine Research Group, Department of Public Health Medicine, Medical School, University of Pécs, Pécs, Hungary.
Malena ChiaborelliDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Johannes M SchwenkeDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Ruben Ramirez ZegarraDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Ramon SaccilottoClinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
Julia M HüllstrungDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Erik von ElmCochrane Switzerland, c/o Cochrane Germany Foundation, Freiburg, Germany.
Arnav AgarwalDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Julian HirtResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland.
David MallDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Alain AmstutzDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Selina EppDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Dominik MertzDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Anette BlümleClinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Belinda von NiederhäusernRoche Pharma AG, Grenzach-Wyhlen, Germany.
Ayodele OdutayoUniversity Health Network, Division of Nephrology, Department of Medicine, University of Toronto, Ontario, Canada.
Alexandra N GriessbachDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Sally HopewellCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Matthias BrielDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
ASPIRE Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Previous work found that 25% to 30% of randomized clinical trials (RCTs) with protocols approved in 2012 or between 2000 and 2003 were discontinued prematurely, most commonly due to inadequate participant recruitment. To minimize research waste, RCTs should be registered and their results made available. Objectives: To assess the fate of RCTs approved by ethics committees in 2016 in terms of nonregistration, discontinuation, and nonpublication, and to examine RCT characteristics associated with discontinuation due to poor recruitment and nonpublication of RCT results. Evidence Review: As a prespecified project of the Adherence to SPIRIT Recommendations (ASPIRE) study, this systematic review had access to 347 RCT protocols approved in 2016 by research ethics committees in the UK, Switzerland, Germany, and Canada. Eligible RCTs were defined as prospective studies randomly assigning participants to interventions to study effects on health outcomes. RCTs were excluded that never started, were ongoing at time of follow-up, were duplicates, or were labeled as pilot, feasibility, or phase 1 trials. Key trial characteristics were extracted from the approved trial protocols. In July 2024, pairs of reviewers systematically searched for trial registrations and results publications. When the status of either was unclear, the corresponding ethics committee or the principal investigator was contacted for clarification. Findings: Of 347 included RCTs, 20 (5.8%) were unregistered, 108 (31.1%) were discontinued, most often due to poor recruitment (49 [45.4%]), and 276 (79.5%) made their results publicly available. Results from industry-sponsored trials were more often available than non-industry-sponsored trials (166 of 181 [92.3%] vs 110 of 166 [66.3%]). This difference was attributable to a higher prevalence of industry-sponsored trials that reported results in trial registries (153 of 181 [84.5%]) vs nonindustry RCTs (17 of 166 [10.2%]). Multivariable logistic regression indicated that industry-sponsored trials were less frequently discontinued due to poor recruitment than non-industry-sponsored RCTs (adjusted odds ratio, 0.32 [95% CI, 0.15-0.71]). Conclusions and Relevance: Findings from this systematic review indicated that nonregistration, premature discontinuation due to poor recruitment, and nonpublication of RCT results remained major challenges, especially for non-industry-sponsored trials. To mitigate these challenges, requirements enforced by funders and ethics committees also taking into account legal obligations should be considered and empirically evaluated.

Indexed as

Early Termination of Clinical TrialsPatient SelectionRandomized Controlled Trials as TopicEthics Committees, ResearchHumans

Identifiers

PMID40899933
PMCPMC12409572

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.