Review by Cary Gross – 03/11/2018 – 8:42am

Data Request Number: 2018-2801 Is the scientific purpose of the research proposal clearly described?: No If no, please explain:

The stated hypothesis is  that “new safety signal detection approach have increased power of identify safety signals at both SOC level and AE level comparing to currently available safety signal detection approaches ”
However, the analytic plan as written does not test this hypothesis.
The main analysis is to be conducted using a “newly developed score test approach”, yet this approach is not described.
The primary study outcome is stated as “grades of all experienced adverse events”.  This is unclear.

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?: Yes, or it’s highly likely Recommendation for this data request: Not Approve

Unclear methods