Review by Joseph Ross – 12/12/2019 – 5:12pm

Data Request Number: 2019-4067 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

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.

Recommendation for this data request: Approve