Use of an exploratory landmark analysis that extends 1-year after the final cut-off date of the pivotal trial
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This 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.