Multi-institutional studies: lessons learned from the Pediatric Heart Network Single Ventricle Reconstruction Trial.

This session of the Congenital Post-Graduate Course 89th Annual Meeting of the American Association for Thoracic Surgery focused on clinical research in pediatric cardiac surgery. This particular lecture concentrated on the management of clinical trials from the viewpoint of a multi-institutional trial, utilizing my experiences as the Study Co-Chair of the National Heart Lung Blood Institute (NHLBI)-funded, Pediatric Heart Network Single Ventricle Reconstruction (SVR) Trial. Preparing for the role as a Primary Investigator through coursework and reading is an important prerequisite. Study design requires thoughtful crafting of the primary question, secondary question, and subanalyses. Often the challenge is not what to include, but what to exclude, to develop a practical database. Getting your co-investigators invested in the trial is crucial, as subject enrollment is time-consuming and will determine the success or failure of your trial.