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 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. 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 ClinicalTrials.gov were appropriate for India public health needs and patients were not enrolled into studies inappropriately from this perspective.

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

Lorenzoni, Giulia;Comoretto, Rosanna Irene;RUFFOLO, MARIANGELA;Azzolina, Danila;Baldi, Ileana
2019

Abstract

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 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. 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 ClinicalTrials.gov were appropriate for India public health needs and patients were not enrolled into studies inappropriately from this perspective.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11577/3286395
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