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Kidney Week

Abstract: PO2353

Assessment of Pediatric Nephrology Programs' Readiness to Participate in Prospective Clinical Trials

Session Information

Category: Pediatric Nephrology

  • 1700 Pediatric Nephrology

Authors

  • Hefley, Shyanne, Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States
  • Howard, Noel, Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States
  • Schnaper, H. William, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
  • Smoyer, William E., Nationwide Children's Hospital, Columbus, Ohio, United States
  • Dell, Katherine MacRae, Cleveland Clinic, Cleveland, Ohio, United States
  • Gross, Coleman, Relypsa Inc, Redwood City, California, United States
  • Twombley, Katherine, Medical University of South Carolina, Charleston, South Carolina, United States
  • Vasylyeva, Tetyana L., Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States
  • Wenderfer, Scott E., Baylor College of Medicine, Houston, Texas, United States
Background

Currently, there is a limited availability of effective, FDA-approved drugs for children with kidney disease in the United States; therefore, there is an increased need for clinical trials to evaluate drug effectiveness and safety for pediatric usage. Implementation and conduction of clinical trials is complex process, which requires a team approach, involves multiple inter-dependent steps, research infrastructure support, legal policies/procedures, equipment, and access to a regulatory oversight board. The conduct of clinical trials in small pediatric subspecialties (i.e. pediatric nephrology) may be hampered by provider clinical demands and small numbers of patients available for such studies.

The goal of this survey was to assess the readiness to conduct clinical trials by pediatric nephrologists in institutions of different sizes. Assessment would also give consideration to the sites for prospective trials and educate the programs about steps needed in clinical research.

Methods


The survey was designed and tested by a small group of pediatric nephrology experts. Qualtrics Online Survey Platform and Statistical analysis were used. The survey was distributed to members of ASPN (60 sites in 30 U.S states and 2 Canadian Provinces). Respondents were asked to complete the survey on behalf of the institution/practice, not their individual preferences. There was a total of 17 survey questions, which assessed the respondent’s institution’s participation/interest in conduction of clinical research, availability of a clinical research coordinator/IRB, and access to equipment for trial execution (dry ice, centrifuges, freezers).

Results

Currently, we have recorded 68 survey responses. Two of the responding institutions had no interest in conducting clinical trials (2.9%). Notably, more respondents practiced at Academic Centers/Universities (91%) than in private practices (8.3%). We noted no major differences in access to clinical trial resources between large and small institutions.

Conclusion


Clinical trials remain vital to finding better treatments and cures for pediatric patients with renal diseases. Overall, pediatric nephrology programs have good infrastructure and readiness to conduct clinical trials independently of the size of the institution.