1. Enhancing clinical trial development for pediatric kidney diseases
- Author
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Lynne Yao, H. William Schnaper, Douglas M. Silverstein, Bastian Dehmel, Aliza Thompson, Coleman Gross, Marva Moxey-Mims, Karen Nowak, Frederick J. Kaskel, William E. Smoyer, Larry A. Greenbaum, Edress Darsey, Joseph T. Flynn, Leah B Patel, Elisabeth Houtsmuller, and Anne B. Cropp
- Subjects
Research design ,Nephrology ,medicine.medical_specialty ,Consensus ,Treatment outcome ,MEDLINE ,Pediatrics ,Article ,Workflow ,03 medical and health sciences ,0302 clinical medicine ,Stakeholder Participation ,030225 pediatrics ,Internal medicine ,medicine ,Humans ,Pediatric nephrology ,030212 general & internal medicine ,Child ,Intensive care medicine ,Clinical Trials as Topic ,business.industry ,Age Factors ,medicine.disease ,3. Good health ,Clinical trial ,Treatment Outcome ,Research Design ,Pediatric nephrologist ,Practice Guidelines as Topic ,Pediatrics, Perinatology and Child Health ,Kidney Diseases ,business ,Kidney disease - 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.
- Published
- 2017
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