Evidence map›Paper›PMID 24427293›Full record

ArticlePloS one2014

The quality of registration of clinical trials: still a problem.

Roderik F Viergever, Ghassan Karam, Andreas Reis, Davina Ghersi

Abstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 8 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

75 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  8. Current status ofIndian journal of pharmacology
    Pooled it
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  20. Trends in Israeli clinical trials registration "MyTrial".Israel journal of health policy research · 2024
    Article

15 more citing papers are in PubMed but not listed here.

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

4 authors.

Roderik F ViergeverDepartment of Primary and Community Care, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands ; Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Ghassan KaramInternational Clinical Trials Registry Platform (ICTRP), Department of Ethics and Social Determinants of Health (ESD), World Health Organization, Geneva, Switzerland.
Andreas ReisDepartment of Ethics and Social Determinants of Health (ESD), World Health Organization, Geneva, Switzerland.
Davina GhersiNHMRC Clinical Trials Centre, Sydney Medical School, University of Sydney, Sydney, Australia.

Funding

World Health Organization 001
6 · The paper itself

Abstract

introductionThe benefits of clinical trials registration include improved transparency on clinical trials for healthcare workers and patients, increased accountability of trialists, the potential to address publication bias and selective reporting, and possibilities for research collaboration and prioritization. However, poor quality of information in registered records of trials has been found to undermine these benefits in the past. Trialists' increasing experience with trial registration and recent developments in registration systems may have positively affected data quality. This study was conducted to investigate whether the quality of registration has improved.

methodsWe repeated a study from 2009, using the same methods and the same research team. A random sample of 400 records of clinical trials that were registered between 01/01/2012 and 01/01/2013 was taken from the International Clinical Trials Registry Platform (ICTRP) and assessed for the quality of information on 1) contact details, 2) interventions and 3) primary outcomes. Results were compared to the equivalent assessments from our previous study.

resultsThere was a small and not statistically significant increase from 81.0% to 85.5% in the percentage of records that provided a name of a contact person. There was a significant increase from 68.7% to 74.9% in the number of records that provided either an email address or a telephone number. There was a significant increase from 44.2% to 51.9% in the number of intervention arms that were complete in registering intervention specifics. There was a significant increase from 38.2% to 57.6% in the number of primary outcomes that were specific measures with a meaningful timeframe. Approximately half of all trials continued to be retrospectively registered. DISCUSSION: There have been small but significant improvements in the quality of registration since 2009. Important problems with quality remain and continue to constitute an impediment to the meaningful utilization of registered trial information.

Indexed as

Clinical Trials as TopicHumansRecordsRegistriesResearch Design

Identifiers

PMID24427293
PMCPMC3888400

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.