@jennifer-carroll thank you for clarifying! That's very helpful.
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Use of an exploratory landmark analysis that extends 1-year after the final cut-off date of the pivotal trial -
Use of an exploratory landmark analysis that extends 1-year after the final cut-off date of the pivotal trial@jennifer-carroll noted! More generally speaking, would PAAB ever consider unplanned, exploratory long-term data in HCP promotional materials if the study population and results aligned with the final analysis trial data in the PM?
Any additional insights you could provide would be much appreciated.
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Use of an exploratory landmark analysis that extends 1-year after the final cut-off date of the pivotal trialThis question relates to the use of updated data (published & peer-reviewed) from an exploratory landmark analysis that included data over 5 years (i.e., 1 year longer than the pivotal trial cut-off period of 4 years). It is essentially the same RCT, endpoints, patients, etc., but it incorporates an extra year of data (exploratory). Note that the data/stats are directionally consistent with the final analysis data, and the reason we want to use it is to include the most up-to-date statistics. I.e., no new inferences would be made and the updated stats would be used (HR, p values, relative risk reduction, etc.). Is this permitted in a promotional context in HCP tools?
Per provision 8 of the PAAB guidance document on KM analysis (https://www.paab.ca/resources/kaplan-meier/), unplanned, or otherwise exploratory, subsequent interim KM analyses can be used to update the KM curve, hazard ratio, and corresponding CI/p-values where a prior pre-planned interim analysis had already established statistical significance between study groups. This is similar to our case described above where we have an exploratory landmark analysis that extends 1 year beyond the final analysis and is directionally consistent with the statistically significant final analysis. Note that this is for an HCP-targeted tool.
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Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?If so, what content would be acceptable to include in such a table? Would it be strictly non-clinical data (e.g., patients characteristics & inclusion criteria)? I assume efficacy data would not be permissible given that it would be for 2 independent trials rather than a head-to-head RCT.