Evidence map›Paper›PMID 36707766›Full record

SynthesisBMC medical research methodology2023

Towards full clinical trial registration and results publication: longitudinal meta-research study in Northwestern and Central Switzerland.

Katharina Klatte, Constantin Sluka, Viktoria Gloy, Ala Taji Heravi, Christof Schönenberger, Nienke Jones, Elena Brunnschweiler, Christiane Pauli-Magnus, Matthias Briel

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

Synthesis in BMC medical research methodology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Observational
  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

9 authors.

Katharina KlatteDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland. Katharina.Klatte@usb.ch.
Constantin SlukaDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland.
Viktoria GloyDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland.
Ala Taji HeraviDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland.
Christof SchönenbergerDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland.
Nienke JonesEthics Committee Northwest and Central Switzerland, Basel, Switzerland.
Elena BrunnschweilerEthics Committee Northwest and Central Switzerland, Basel, Switzerland.
Christiane Pauli-Magnus *Department of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland.
Matthias Briel *Department of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, CH, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe registration of clinical trials is required by law in Switzerland. We investigated (1) the proportion of registered and prospectively registered clinical trials, (2) the availability of results for ethically approved trial protocols, (3) factors associated with increased registration, and (4) reasons for non-registration. DESIGN AND

settingWe included all clinical trials with mandatory prospective registration, which were approved by the ethics committee of Northwestern and Central Switzerland between January 1, 2016, and December 31, 2020.

methodsWe extracted relevant trial characteristics from the Swiss Business Administration System for Ethics Committees and systematically searched the International Clinical Trials Registry Platform and primary trial registries for corresponding registry entries. We used multivariable logistic regression to examine the association between trial characteristics and registration. We qualitatively assessed reasons for non-registration of trials through an email questionnaire for trial investigators.

resultsOf 473 included clinical trials, 432 (91%) were registered at all and 326 (69%) were prospectively registered. While the percentages of registration and prospective registration of investigator-sponsored trials increased from 85 to 93% and from 59 to 70% over 5 years, respectively, industry-sponsored trials consistently remained at a high level of prospective registration (92 to 100%). Trials with multiple centres, higher risk category, or methodological support from the local clinical trials unit were independently associated with increased registration rates. Of 103 clinical trials completed before August 2020, results were available for 70% of industry-sponsored trials and 45% of investigator-sponsored trials as peer-reviewed journal publications or in trial registries. Most common reasons for non-registration provided by investigators were lack of time or resources (53%), lack of knowledge (22%), and lack of reminders by the ethics committee (36%).

conclusionsIn Northwestern and Central Switzerland about 10% of clinical trials remained unregistered despite the obligation by law. More support for investigators and stricter enforcement by regulators are needed to improve the transparency of investigator-sponsored trials in particular.

Indexed as

Clinical Trials as TopicRegistriesHumansLongitudinal StudiesProspective StudiesSurveys and QuestionnairesSwitzerlandLegal obligationNon-registration reasonsRandomized controlled trialsSwitzerlandTrial registration

Identifiers

PMID36707766
PMCPMC9880919

What Socratic 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 Socratic graph.