• Random question, but wondering if an unadjusted p-value can ever be used to support a claim in an APS directed at HCPs?

  • @COREkarentaylor, yes, there are circumstances where an unadjusted p-value can be used to support a claim in an APS directed at HCPs. In fact, even when adjustments would have been required to mitigate familywise type 1 error rate, a claim-neutral presentation of the data may be acceptable. Here are some of the key points you’d want to keep in mind.

    When the study and secondary endpoint do not (in and of themselves) contravene the code, data may be presented in a factual unembellished manner. When there is no adjustment for multiplicity, the claim should appear neutral. Simply present data with corresponding stats (text or graphic form) without the addition of elements to the data presentation which suggest an improvement or difference (e.g. relative reduction callouts/arrows, NNT). Claim neutrality also applies to context (e.g. headlines & tabs). Introduce the data presentations with “topics” (e.g. “efficacy” as opposed to conclusions (e.g. demonstrated powerful efficacy). The presentation must state that the presented CI or p-value is unadjusted. For example, it suffices to insert “(unadjusted)” next to the CI or p-value. Note that p-values & CI cannot be relegated to weblink destinations. Essentially, provided statistical analysis is presented to satisfy s5.9, we’ll allow a data presentation. But we’ll reject overt and contextually implied claims of efficacy/safety/difference.

    For subgroups, in addition to the above, one must present the subgroup of interest along with all of the complementary subgroups with equal emphasis (such that none stands out). E.g. Can’t just present male data, must present both male and female data3.

    Note that this response assumes the primary endpoint was statistically significant. Secondary endpoints cannot be used to salvage a failed study.