Review by Richard Lehman – 06/11/2019 – 4:15pm

Data Request Number: 2019-3864 Is the scientific purpose of the research proposal clearly described?: No If no, please explain:

There are important sections of the proposal where I simply don’t understand the language, e.g. “The study will look at clinical trial and EHR data to find the commonality in the data that is shared accords different platforms.” …
or “The study compares that information found in trials with that in everyday medicine. The goal of this study is to look at the trials and everyday information and understand what information is reported in each and compare them to find commonalities and differences.” 
The proposal seems to range across all sorts of data inputs without a clear analytic structure. 

Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Unsure, further clarification from requestor is needed 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):

I am not convinced that the requestors have a sufficiently developed a categorization of the data elements they wish to capture or how they can be compared from these disparate sources. This could in part be a language issue. 

Recommendation for this data request: Not Approve

The applicants need to reframe and clarify their proposal, especially their analytic plan.