Evidence map›Paper›PMID 38031096›Full record

ArticleBMC medicine2023

Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study.

Maia Salholz-Hillel, Molly Pugh-Jones, Nicole Hildebrand, Tjada A Schult, Johannes Schwietering, Peter Grabitz, Benjamin Gregory Carlisle, Ben Goldacre, Daniel Strech, Nicholas J DeVito

Abstract read
In one paragraph

Article in BMC medicine, 2023. 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. Observational
  2. Review
  3. Article
  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

10 authors.

Maia Salholz-HillelQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Molly Pugh-JonesQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Nicole HildebrandQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Tjada A SchultQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Johannes SchwieteringQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Peter GrabitzQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Benjamin Gregory CarlisleQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Ben GoldacreBennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Daniel StrechQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitätsmedizin Berlin, Berlin, Germany.
Nicholas J DeVitoBennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. nicholas.devito@phc.ox.ac.uk.ORCID 0000-0001-8286-1995

Funding

Bundesministerium für Bildung und Forschung 01KX2021
6 · The paper itself

Abstract

backgroundThe results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic.

methodsClinical trials for COVID-19 treatment or prevention were identified from the WHO ICTRP database. All interventional trials with a registered completion date ≤ 30 June 2021 were included. Trial results, published as preprints, journal articles, or registry results, were located using automated and manual techniques across PubMed, Google Scholar, Google, EuropePMC, CORD-19, the Cochrane COVID-19 Study Register, and clinical trial registries. Our main analysis reports the rate of dissemination overall and per route, and the time from registered completion to results using Kaplan-Meier methods, with additional subgroup and sensitivity analyses reported.

resultsOverall, 1643 trials with completion dates ranging from 46 to 561 days prior to the start of results searches were included. The cumulative probability of reporting was 12.5% at 3 months from completion, 21.6% at 6 months, and 32.8% at 12 months. Trial results were most commonly disseminated in journals (n = 278 trials, 69.2%); preprints were available for 194 trials (48.3%), 86 (44.3%) of which converted to a full journal article. Trials completed earlier in the pandemic were reported more rapidly than those later in the pandemic, and those involving ivermectin were more rapidly reported than other common interventions. Results were robust to various sensitivity analyses except when considering only trials in a "completed" status on the registry, which substantially increased reporting rates. Poor trial registry data on completion status and dates limits the precision of estimates.

conclusionsCOVID-19 trials saw marginal increases in reporting rates compared to standard practice; most registered trials failed to meet even the 12-month non-pandemic standard. Preprints were common, complementing journal publication; however, registries were underutilized for rapid reporting. Maintaining registry data enables accurate representation of clinical research; failing to do so undermines these registries' use for public accountability and analysis. Addressing rapid reporting and registry data quality must be emphasized at global, national, and institutional levels.

Indexed as

COVID-19COVID-19 Drug TreatmentCross-Sectional StudiesHumansRegistriesResearch DesignClinical trialsClinical trials transparencyCOVID-19Research integrityResults reporting

Identifiers

PMID38031096
PMCPMC10687901

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.