Clinical research in pediatric nephrology: challenges, and strategies to address them.
There are many obstacles to conducting meaningful clinical research studies in children with kidney disease. This review describes some of the challenges facing clinical investigators in pediatric nephrology, and proposes strategies to overcome them. Four broad categories of challenges are considered: inadequate power, funding issues, ethical issues and practical barriers. Power is influenced not just by sample size, but also by population heterogeneity and the outcome chosen; these issues are discussed in detail. Ethical issues and practical barriers of particular relevance to pediatric studies are considered. Examples of successful multicenter studies are provided. In addition, some of the strengths and limitations of existing registry data are highlighted.
Foster
Bethany J
BJ
Department of Pediatrics, Division of Nephrology, Montreal Children's Hospital, McGill University School of Medicine, Quebec, Canada. beth.foster@muhc.mcgill.ca
Warady
Bradley A
BA
D002648:Child; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000379:methods; D023381:Endpoint Determination; D019317:Evidence-Based Medicine; D006801:Humans; D007674:Kidney Diseases / Q000628:therapy*; D015337:Multicenter Studies as Topic; D009398:Nephrology / Q000191:economics / Q000941:ethics; D010372:Pediatrics / Q000191:economics / Q000941:ethics; D012042:Registries; D012109:Research Support as Topic; D018401:Sample Size; D016896:Treatment Outcome