Enhancing clinical trial development for pediatric kidney diseases

Pediatr Res. 2017 Nov;82(5):727-732. doi: 10.1038/pr.2017.180. Epub 2017 Aug 30.

Abstract

The conduct of clinical trials in small pediatric subspecialties such as pediatric nephrology is hampered by both clinical demands on the pediatric nephrologist and the small number of appropriate patients available for such studies. The American Society of Pediatric Nephrology Therapeutics Development Committee (TDC) was established to (1) identify the various stakeholders with interests and/or expertise related to clinical trials in children with kidney disease and (2) develop more effective partnerships among all parties regarding strategies for successful clinical trial development and execution. This article discusses the rationale, structure, and function of the TDC, the status of progress toward its goals, and the insights gained to date that may be useful for other subspecialties that face similar challenges.

Publication types

  • Review

MeSH terms

  • Age Factors
  • Child
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / standards
  • Consensus
  • Humans
  • Kidney Diseases / diagnosis
  • Kidney Diseases / epidemiology
  • Kidney Diseases / therapy*
  • Nephrology / methods*
  • Nephrology / standards
  • Pediatrics / methods*
  • Pediatrics / standards
  • Practice Guidelines as Topic
  • Research Design* / standards
  • Stakeholder Participation
  • Treatment Outcome
  • Workflow