Interim timepoints not in PM
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In our PM, the data for an endpoint are reported only for baseline and the final timepoint (example, Week 52). There is no mention of interim timepoints in the PM. However, the trial publication contains a chart showing the data for the interim time points (example, every 2 weeks) - would it be acceptable to include these charts, with the interim time points, in a branded, HCP-directed piece?
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In our PM, the data for an endpoint are reported only for baseline and the final timepoint (example, Week 52). There is no mention of interim timepoints in the PM. However, the trial publication contains a chart showing the data for the interim time points (example, every 2 weeks) - would it be acceptable to include these charts, with the interim time points, in a branded, HCP-directed piece?
Hello @kbernard
Providing the published study meets PAAB requirements as a standalone trial, as a general rule of thumb, if the timepoints are predefined, tested for statistical significance, and are directionally consistent with the primary endpoint, it would be acceptable to present them in the piece in a non-selective and complete manner.
