Evidence map›Paper›PMID 34810189›Full record

ArticleBMJ open2021

Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study.

Maia Salholz-Hillel, Peter Grabitz, Molly Pugh-Jones, Daniel Strech, Nicholas J DeVito

Abstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–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

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
    Pooled it
  3. Pooled it
  4. Article
  5. Article
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  8. Clinical trial research agenda on COVID-19 - the first two years in Germany and beyond.Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen · 2022
    Review
  9. 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

5 authors.

Maia Salholz-Hillel *QUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-1934-9504
Peter Grabitz *QUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID 0000-0001-5658-2482
Molly Pugh-JonesQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitatsmedizin Berlin, Berlin, Germany.
Daniel StrechQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitatsmedizin Berlin, Berlin, Germany.
Nicholas J DeVito *DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK nicholas.devito@phc.ox.ac.uk.ORCID 0000-0001-8286-1995

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.

designCross-sectional study.

settingThe COVID-19 clinical trial landscape.

participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.

main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.

resultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.

conclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

Indexed as

COVID-19Cross-Sectional StudiesHumansPandemicsRegistriesReproducibility of ResultsSARS-CoV-2clinical trialshealth policymedical ethics

Identifiers

PMID34810189
PMCPMC8609493

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.