The Pediatric Heart Network: A primer for the conduct of multicenter studies in children with congenital and acquired heart disease

L. Mahony, L. A. Sleeper, P. A W Anderson, W. M. Gersony, B. W. McCrindle, L. L. Minich, J. W. Newburger, J. P. Saul, V. L. Vetter, G. D. Pearson

Research output: Contribution to journalArticle

59 Citations (Scopus)

Abstract

Most contemporary diagnostic and treatment strategies for pediatric patients 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. The purposes of this article are to describe the initiation, structure, and function of the PHN; to review the ongoing studies; and to address current and future challenges. To date, four randomized clinical trials and two observational studies have been launched. Design and conduct of complex, multicenter studies in children with congenital and acquired heart disease must address numerous challenges, including identification of an appropriate clinically relevant primary endpoint, lack of preliminary data on which to base sample size calculations, and recruitment of an adequate number of subjects. The infrastructure is now well developed and capable of implementing complex, multicenter protocols efficiently and recruiting subjects effectively. The PHN is uniquely positioned to contribute to providing evidence-based medicine for and improving the outcomes of pediatric patients with cardiovascular disease.

Original languageEnglish (US)
Pages (from-to)191-198
Number of pages8
JournalPediatric Cardiology
Volume27
Issue number2
DOIs
StatePublished - Apr 2006

Fingerprint

Multicenter Studies
Heart Diseases
Pediatrics
Observational Studies
Cardiovascular Diseases
National Heart, Lung, and Blood Institute (U.S.)
Evidence-Based Medicine
Expert Testimony
Sample Size
Randomized Controlled Trials
Medicine
Clinical Trials
Research
Therapeutics

Keywords

  • Clinical trials
  • Congenital heart disease
  • Pediatric clinical research

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pediatrics, Perinatology, and Child Health

Cite this

The Pediatric Heart Network : A primer for the conduct of multicenter studies in children with congenital and acquired heart disease. / Mahony, L.; Sleeper, L. A.; Anderson, P. A W; Gersony, W. M.; McCrindle, B. W.; Minich, L. L.; Newburger, J. W.; Saul, J. P.; Vetter, V. L.; Pearson, G. D.

In: Pediatric Cardiology, Vol. 27, No. 2, 04.2006, p. 191-198.

Research output: Contribution to journalArticle

Mahony, L, Sleeper, LA, Anderson, PAW, Gersony, WM, McCrindle, BW, Minich, LL, Newburger, JW, Saul, JP, Vetter, VL & Pearson, GD 2006, 'The Pediatric Heart Network: A primer for the conduct of multicenter studies in children with congenital and acquired heart disease', Pediatric Cardiology, vol. 27, no. 2, pp. 191-198. https://doi.org/10.1007/s00246-005-1151-9
Mahony, L. ; Sleeper, L. A. ; Anderson, P. A W ; Gersony, W. M. ; McCrindle, B. W. ; Minich, L. L. ; Newburger, J. W. ; Saul, J. P. ; Vetter, V. L. ; Pearson, G. D. / The Pediatric Heart Network : A primer for the conduct of multicenter studies in children with congenital and acquired heart disease. In: Pediatric Cardiology. 2006 ; Vol. 27, No. 2. pp. 191-198.
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