Abstract:
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The ASA Biopharm section’s “Nonclinical Biostatistics Scientific Working Group on P-values” was formed in 2020, in response to the position papers by Wasserstein, Schirm and Lazar (2019) “Moving to a World Beyond “p?< ?0.05”, and an earlier ASA statement on p-values by Wasserstein and Lazar (2016). The scientific working group was comprised of three subgroups: 1. Discovery/-Omics, 2. Preclinical Pharmacology/Safety/Toxicology and 3. Chemistry, Manufacturing and Controls (Small and Large Molecules) representing the three broad subject areas of nonclinical research, development, and lifecycle management. Each of the subgroups embarked on a survey to identify specific statistical applications which rely on a p-value criterion for decision making. This poster summarizes the review of p-values driving decision making in the nonclinical space and summarizes the working Group’s recommendations. These have advanced statistical practice in selected nonclinical applications while harmonizing with the ASA position on p-values.
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