Review by Nihar Desai – 07/17/2017 – 9:48am

Data Request Number: 2017-1746 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 proposal — requesting 38 trials through YODA in addition to about 200 trials the authors already have access to.  My major concern is that we have few detail on the diseases and outcomes of interest. The authors provide diabetes as an example but then claim at HbA1c is the outcome of interest.  Why look at a surrogate like HbA1c (for which there is surely heterogeneity based on clinical comorbidities) instead of looking at clinical endpoints (CV death, MI, stroke). 

Recommendation for this data request: Not Approve

I would respectfully ask the authors to supply additional details.