Evidence map›Paper›PMID 39080524›Full record

ArticleBMC medical research methodology2024

Accelerating evidence synthesis for safety assessment through ClinicalTrials.gov platform: a feasibility study.

Tianqi Yu, Xi Yang, Justin Clark, Lifeng Lin, Luis Furuya-Kanamori, Chang Xu

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. [Analysis of the global registration status of clinical trials for artificial intelligence medical device].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2025
    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

6 authors.

Tianqi YuCenter of Research in Epidemiology and Statistics, Université Paris Cité, Inserm, Paris, France.
Xi YangDepartment of Maternal, Child and Adolescent Health, School of Public Health, Anhui Medical University, Hefei, Anhui, China.
Justin ClarkInstitute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.
Lifeng LinDepartment of Epidemiology and Biostatistics, University of Arizona, Tucson, AZ, USA.
Luis Furuya-KanamoriUQ Centre for Clinical Research, The University of Queensland, Herston, Australia.
Chang XuProof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China. xuchang2016@runbox.com.

Funding

National Natural Science Foundation of China 72204003
6 · The paper itself

Abstract

backgroundStandard systematic review can be labor-intensive and time-consuming meaning that it can be difficult to provide timely evidence when there is an urgent public health emergency such as a pandemic. The ClinicalTrials.gov provides a promising way to accelerate evidence production.

methodsWe conducted a search on PubMed to gather systematic reviews containing a minimum of 5 studies focused on safety aspects derived from randomized controlled trials (RCTs) of pharmacological interventions, aiming to establish a real-world dataset. The registration information of each trial from eligible reviews was further collected and verified. The meta-analytic data were then re-analyzed by using 1) the full meta-analytic data with all trials and 2) emulated rapid data with trials that had been registered and posted results on ClinicalTrials.gov, under the same synthesis methods. The effect estimates of the full meta-analysis and rapid meta-analysis were then compared.

resultsThe real-world dataset comprises 558 meta-analyses. Among them, 56 (10.0%) meta-analyses included RCTs that were not registered in ClinicalTrials.gov. For the remaining 502 meta-analyses, the median percentage of RCTs registered within each meta-analysis is 70.1% (interquartile range: 33.3% to 88.9%). Under a 20% bias threshold, rapid meta-analyses conducted through ClinicalTrials.gov achieved accurate point estimates ranging from 77.4% (using the MH model) to 83.1% (using the GLMM model); 91.0% to 95.3% of these analyses accurately predicted the direction of effects.

conclusionsUtilizing the ClinicalTrials.gov platform for safety assessment with a minimum of 5 RCTs holds significant potential for accelerating evidence synthesis to support urgent decision-making.

Indexed as

Feasibility StudiesMeta-Analysis as TopicRandomized Controlled Trials as TopicDatabases, FactualHumansRegistriesSystematic Reviews as TopicClinicalTrials.govEmpirical investigationEvidence synthesisSafety assessment

Identifiers

PMID39080524
PMCPMC11290241

What OpenQuestion holds

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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.