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

Giulia Lorenzoni1, Rosanna Irene Comoretto1, Mariangela Ruffolo1

  • 1Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.

Indian Journal of Pediatrics
|January 17, 2019
PubMed

Insights

This study analyzed pediatric clinical trials in India between 2006-2015. Most trials focused on treatment and prevention, aligning with India

Area of Science:

  • Pediatric Clinical Research
  • Global Health Trials
  • Clinical Trial Analysis

Background:

  • Examining a decade of pediatric clinical trials (2006-2015) with a focus on sites in India.
  • Utilizing the Aggregate Analysis of ClinicalTrials.gov (AACT) database for comprehensive data extraction.

Observation:

  • Identified 9,648 pediatric interventional studies, with 193 having at least one site in India.
  • Most trials targeted treatment (92) and prevention (65) with efficacy/safety endpoints (158).
  • Infants and toddlers were primary participants (97%), while neonates were included in 22% of trials. Early termination/withdrawal rate was 5%.

Findings:

  • Commonly studied conditions included bacterial infections, viral infections, digestive diseases, and mental health disorders.
  • Both communicable (75) and non-communicable (72) diseases were equally investigated.
  • Therapeutic areas in Indian trials aligned with public health needs, ensuring appropriate patient enrollment.

Implications:

  • Highlights the alignment of clinical research in India with national public health priorities.
  • Provides insights into pediatric trial enrollment and focus areas for future research in India.
  • Demonstrates the value of systematic analysis of clinical trial data for understanding research landscapes.
Abstract

Keywords:
Clinical trialClinicalTrials.govNon-communicable diseases

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