Evidence map›Paper›PMID 38649798›Full record

ArticleBMC medical research methodology2024

Reporting of interventional clinical trial results in an academic center: a survey of completed studies.

Anne Sophie Alix-Doucet, Constant Vinatier, Loïc Fin, Hervé Léna, Hélène Rangé, Clara Locher, Florian Naudet

Abstract read
In one paragraph

Article in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

7 authors.

Anne Sophie Alix-DoucetResearch and Innovation Department, CHU Rennes, Rennes, France.
Constant VinatierUniv Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de Recherche en Santé Environnement Et Travail)-UMR_S 1085, CIC 1414 [(Centre d'investigation clinique de Rennes)], F- 35000, Rennes, France.
Loïc FinResearch and Innovation Department, CHU Rennes, Rennes, France.
Hervé LénaCentre Hospitalier Universitaire, Hôpital de Pontchaillou, INSERM U 1242, Université Rennes 1, Rennes, France.
Hélène RangéCIC 1414 [(Centre d'Investigation Clinique de Rennes)], Univ Rennes, CHU Rennes, Inserm, Institut Numecan (Nutrition, Métabolismes Et Cancer) -UMR_S 1317, Rennes, France.
Clara LocherUniv Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de Recherche en Santé Environnement Et Travail)-UMR_S 1085, CIC 1414 [(Centre d'investigation clinique de Rennes)], F- 35000, Rennes, France.
Florian NaudetUniv Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de Recherche en Santé Environnement Et Travail)-UMR_S 1085, CIC 1414 [(Centre d'investigation clinique de Rennes)], F- 35000, Rennes, France. floriannaudet@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe dissemination of clinical trial results is an important scientific and ethical endeavour. This survey of completed interventional studies in a French academic center describes their reporting status.

methodsWe explored all interventional studies sponsored by Rennes University Hospital identified on the French Open Science Monitor which tracks trials registered on EUCTR or clinicaltrials.gov, and provides an automatic assessment of the reporting of results. For each study, we ascertained the actual reporting of results using systematic searches on the hospital internal database, bibliographic databases (Google Scholar, PubMed), and by contacting all principal investigators (PIs). We describe several features (including total budget and numbers of trial participants) of the studies that did not report any results.

resultsThe French Open Science Monitor identified 93 interventional studies, among which 10 (11%) reported results. In contrast, our survey identified 36 studies (39%) reporting primary analysis results and an additional 18 (19%) reporting results for secondary analyses (without results for their primary analysis). The overall budget for studies that did not report any results was estimated to be €5,051,253 for a total of 6,735 trial participants. The most frequent reasons for the absence of results reported by PIs were lack of time for 18 (42%), and logistic difficulties (e.g. delay in obtaining results or another blocking factor) for 12 (28%). An association was found between non-publication and negative results (adjusted Odds Ratio = 4.70, 95% Confidence Interval [1.67;14.11]).

conclusionsEven allowing for the fact that automatic searches underestimate the number of studies with published results, the level of reporting was disappointingly low. This amounts to a waste of trial participants' implication and money. Corrective actions are needed.

trial registrationhttps://osf.io/q5hcs.

Indexed as

Clinical Trials as TopicAcademic Medical CentersCross-Sectional StudiesFranceHumansResearch DesignSurveys and QuestionnairesAuditClinical studiesOpen SciencePublicationResults

Identifiers

PMID38649798
PMCPMC11034140

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.