A Bayesian phase 2 model based adaptive design to optimise antivenom dosing: Application to a dose-finding trial for a novel Russell's viper antivenom in Myanmar.

• Main Authors: James A Watson (Author), Thomas Lamb (Author), Jane Holmes (Author), David A Warrell (Author), Khin Thida Thwin (Author), Zaw Lynn Aung (Author), Min Zaw Oo (Author), Myat Thet Nwe (Author), Frank Smithuis (Author), Elizabeth A Ashley (Author)
• Format: Book
• Published: Public Library of Science (PLoS), 2020-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

For most antivenoms there is little information from clinical studies to infer the relationship between dose and efficacy or dose and toxicity. Antivenom dose-finding studies usually recruit too few patients (e.g. fewer than 20) relative to clinically significant event rates (e.g. 5%). Model based a...