Evidence map›Paper›PMID 30648225›Full record

ReviewIndian journal of pediatrics2019

Pediatric Trials Run in India: An Analysis of Clinical Trials.gov 2006-2015.

Giulia Lorenzoni, Rosanna Irene Comoretto, Mariangela Ruffolo, Danila Azzolina, Ileana Baldi

Abstract readHistorical ArticleReview
PubMed Publisher
In one paragraph

Review in Indian journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

5 authors.

Giulia LorenzoniUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Rosanna Irene ComorettoUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Mariangela RuffoloUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Danila AzzolinaUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Ileana BaldiUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy. ileana.baldi@unipd.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo present a snapshot of 10 y of pediatric research, with a focus on trials with at least one enrolling site in India.

methodsThe study included all interventional trials registered at ClinicalTrials.gov from January 2006 through December 2015, enrolling patients aged 0 to 18 y. The database for Aggregate Analysis of ClinicalTrials.gov (AACT) was the data source used.

resultsNine thousand, six hundred forty-eight pediatric clinical studies were identified. Of these, 193 had at least one enrolling site in India. The primary purpose for most of these trials was treatment (n = 92) and prevention (n = 65) coupled with an efficacy and/or safety endpoint (n = 158). Infant and toddlers were eligible for enrollment in the majority of trials (97%) while neonates only in 22% of trials. The rate of early termination or withdrawal was 5%. The most commonly studied conditions were bacterial infections, viruses, digestive and mental diseases. Overall, communicable diseases (n = 75) and major non-communicable diseases (n = 72) were equally investigated.

conclusionsThe most commonly studied therapeutic areas in trials enrolling from India and registered in ClinicalTrials.gov were appropriate for India public health needs and patients were not enrolled into studies inappropriately from this perspective.

Indexed as

Child HealthClinical Trials as TopicAdolescentCardiovascular DiseasesChildChild, PreschoolCommunicable DiseasesDatabases, FactualHistory, 21st CenturyHumansIndiaInfantInfant, NewbornMental DisordersNeoplasmsNoncommunicable DiseasesClinical trialClinicalTrials.govNon-communicable diseases

Identifiers

PMID30648225

What OpenQuestion holds

Textmetadata
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.