Review by Joseph Ross – 12/08/2015 – 4:19pm

Data Request Number: 2015-0649 Please use this space to provide any comments, feedback or concerns (optional):

There are several outstanding issues that should be addressed before approval.
First, please clarify what population characteristics are of interest? Is the focus on demographic characteristics or clinical characteristics (or both), including disease severity.
Second, please clarify the approach that justifies the need for Individual-level Patient Data (IPD). If demographic and clinical characteristics will be examined independently, IPD would seem to be unnecessary and the trial population characteristics could be discerned from the CSR summary document. If a matrix of characteristics will be examined, that would require IPD but should be pre-specified.
Third, currently, no information is provided on how the metric (score) would be developed to quantify the population representativeness of each trial. Will different characteristics be weighted? How will the analysis be approached? The methods text does not adequately describe the planned work, both in terms of how the main outcome measure will be developed (the metric) or the statistical analysis plan.

Recommendation for this data request: Not Approve

See comments above.