Review by Richard Lehman – 07/01/2020 – 4:11pm

Data Request Number: 2020-4317 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?: No If no, please explain:

This is a single very arcane trial being used to address a major analytic issue. To do this adequately would require a large set of trials addressing a range of important clinical questions. I cannot see how it would be possible to generalise from the proposed analysis. 

Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Recommendation for this data request: Not Approve

Please see comments above. This does not seem to be of potential scientific interest, more a trial run of their analytic framework.