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

Indian J Pediatr. 2019 Jan;86(Suppl 1):10-14. doi: 10.1007/s12098-018-2825-7. Epub 2019 Jan 16.


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

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

Results: Nine 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.

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

Keywords: Clinical trial;; Non-communicable diseases.

Publication types

  • Historical Article
  • Review

MeSH terms

  • Adolescent
  • Cardiovascular Diseases
  • Child
  • Child Health*
  • Child, Preschool
  • Clinical Trials as Topic*
  • Communicable Diseases
  • Databases, Factual / history*
  • Databases, Factual / statistics & numerical data*
  • History, 21st Century
  • Humans
  • India
  • Infant
  • Infant, Newborn
  • Mental Disorders
  • Neoplasms
  • Noncommunicable Diseases
  • Public Health
  • Registries / statistics & numerical data