Abstract 13032: Characteristics of Pediatric Cardiovascular Clinical Trials Registered on ClinicalTrails.gov
Background: ClinicalTrials.gov is an NIH-sponsored registry of federally and privately funded trials. Beginning 09/27/2007, the Food and Drug Administration implemented more rigorous trial registration requirements to improve data and increase registration. We sought to determine fundamental characteristics of registered pediatric cardiovascular trials (PCVTs).
Methods: A data set including 68134 interventional clinical trials was downloaded from ClinicalTrials.gov on 9/27/2010, and entered into a relational database. Aggregate data from PCVTs were analyzed with a focus on trial characteristics, trends and comparison with adult cardiovascular trials (ACVTs).
Results: Between 7/01/2005 and 9/27/2010, 5035 (7%) registered trials targeted pediatric populations, of which 4% (n=203) were PCVTs. Median PCVT enrollment was 65 (IQR: 36, 180) with primary endpoints of safety (5%), efficacy (37%), safety/efficacy (46%), and pharmacometrics (11%). Compared to ACVTs (n=3075), PCVTs were less frequently NIH- or industry-sponsored (30% v. 47%) and involved more drug (57% v. 48%) and less device (5% v. 23%) interventions. Despite new reporting mandates, there was a decline in the yearly number of PCVTs registered before (era 1) and after (era 2) 10/01/2007 primarily due to a decline in US trials (table). Between era 1 and era 2 there was a 46% decrease in the proportion of NIH- or industry-sponsored PCVTs while concurrent industry- or NIH-sponsored adult trials decreased by 11%.
Conclusion: PCVTs reported on clinicaltrials.gov represent a small proportion of pediatric clinical trials and are dwarfed by ACVTs. The number and proportion of industry or NIH-funded PCVTs appears to be decreasing, and increasingly these trials are being conducted outside of the US. These data may be useful to stakeholders in informing decisions regarding the conduct of PCVTs, and to provide insight into mechanisms to advance PCVT infrastructure.
- © 2012 by American Heart Association, Inc.