Analysis of clinical drug trials in children compared to clinical drug trials in adults, in Argentina.

Abstract

INTRODUCTION\nIt is necessary to know the extent and subject matter of pediatric clinical drug research in Argentina and establish the differences with the adult population.\n\n\nOBJECTIVES\nTo compare adult and pediatric clinical drug trials in terms of number, phase, design (placebo as control, proportion of blind/open-label trials), studied diseases. Specifically in pediatrics, to determine if studied diseases are consistent with the leading causes of infant and child mortality in Argentina.\n\n\nMETHODS\nAnalytical, observational, crosssectional study conducted at the National Drug, Food and Technology Administration of Argentina (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) in trials approved between 2011 and 2014.\n\n\nRESULTS\nOut of 614 trials, 552 (90 %) were done in adults and 62 (10 %), in children. Phase III studies predominated in both adults (77 %) and children (69 %). In relation to study design, placebo control (49 %) and blinding (74 %) were more common in adults compared to children (31 % and 58 %, respectively). The most frequently studied diseases were tumors in adults and respiratory, musculoskeletal and connective tissue diseases in children. No correlation was observed between studied diseases and infant and child mortality.\n\n\nCONCLUSIONS\n1) More studies were done in adults than in children; 2) most studies corresponded to phase III; 3) differences in study design were observed between children and adults; 4) studied diseases were different in each population; 5) in pediatrics, no correlation was observed between the studied diseases and the leading causes of infant and child mortality in Argentina.