Clinical Trials: A Call for Collaboration Between Pediatrics and Internal Medicine.
Researchers
Rona M Smith, William E Smoyer, Louise Oni, Anne Rohall, Cal H Robinson, Lynne Yao, David Fuller, Rulan S Parekh, Kevin Fowler, Mark D Lim, Howard Trachtman
Abstract
The conduct of randomized clinical trials (RCTs) in kidney disease among children and older youth has historically been challenging, reflecting, in part, the relative rarity of the conditions. This has resulted in a 13-year gap between the granting of approval for novel therapies in adults and their subsequent approval in children and created a significant lag in access to drugs in pediatrics that treat kidney disorders. One contributing factor that has been neglected is the operational barriers created by cultural and institutional structures that (1) divide pediatric from adult clinical nephrology services and (2) ignore the challenge for older pediatric patients who enroll in RCTs and straddle the boundary between pediatrics and internal medicine. In this Perspective, we offer potential approaches to overcome the human, logistical, and administrative impediments to meaningful collaboration between pediatric and adult nephrologists with the objective of promoting the timely initiation and completion of RCTs in pediatric nephrology.Source: PubMed (PMID: 42966595)View Original on PubMed