招請講演 
Overview of the pediatric heart network: multicenter studies of congenital and acquired cardiovascular disease in children
Pediatric Heart Network Investigators, University of Texas Southwestern Medical Center, USA
Lynn Mahony
Most current diagnostic and treatment plans for infants and children with cardiovascular disease are not supported by evidence from clinical trials, but instead are based on expert opinion, single-institution observational studies, or extrapolated from adult cardiovascular medicine. In response to this concern, the National Heart, Lung, and Blood Institute established the Pediatric Heart Disease Clinical Research Network (PHN) in 2001. Design and conduct of complex, multicenter studies in children with congenital and acquired heart disease must address numerous obstacles, including identification of an suitable clinically-relevant primary endpoint, lack of preliminary data on which to base sample size calculations, and recruitment of a sufficient number of subjects. To date, the PHN has initiated five randomized clinical trials and three observational. This presentation will describe the structure and function of the PHN, review ongoing studies, and discuss current and future challenges. Despite numerous challenges, the infrastructure is now well-developed and capable of implementing complex, multicenter protocols efficiently and recruiting subjects effectively.


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