Survey and Recommendations on the Use of P-Values Driving Decisions in Nonclinical Applications

• Activity Number: 153 - Contributed Poster Presentations: Biopharmaceutical Section
• Type: Contributed
• Date/Time: Monday, August 8, 2022 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Stan Altan* and Helena Geys and Steven Novick
• Companies: Janssen R&D and Janssen R&D and Astra Zeneca R&D
• Keywords: p-value; nonclinical biostatistics; statistical practice ; biopharmaceutical statistics

Abstract

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.