This is an interesting study and has great potential value. However, I was confused by the investigators request for data from more than 40 trials, the vast majority of which were studies of adults aged 18-65 years (based on my quick review). Which of these studies will be used to evaluate early treatment endpoints among pediatric patients? Or, is the larger study intended to identify surrogates from adult data that could potentially be applied to pediatric patients? Perhaps I am just misunderstanding, but further clarification would be useful because the resources required to make 40+ trials available, as opposed to a handful, are not insignificant.
Approve