Review by Joseph Ross – 03/24/2020 – 12:00pm

Data Request Number: 2020-4243 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?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

This is a potentially important study attempting to compare the characteristics and outcomes experienced by patients in 5 clinical trials of simeprevir to patients receiving treatment in the real-world. However, the proposal is fairly vague and would benefit from further specificity, including:
1) clarifying whether only patients receiving simeprevir be studied, or will attempts be made to compare “placebo” patients as well.
2) specifying which demographic and clinical characteristics will be compared among trial and “real-world” patients.
3) clarifying the statistical test used to compare population characteristics.
4) clarifying whether all AEs will be ascertained, or only serious AEs, in addition to ‘hyperbilirubinemia’ AEs specifically.
5) clarifying whether the investigators intend to compare the % of trial and “real-world” patients experiencing AEs (and achieving SVR) – right now the investigators propose to compare the ‘numbers’ – and what statistical test will be used to compare AE and efficacy rates.

Recommendation for this data request: Not Approve

see above