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, Thomas Lamb, Jane Holmes, David A. Warrell, Khin Thida Thwin, Zaw Lynn Aung, Min Zaw Oo, Myat Thet Nwe, Frank Smithuis, Elizabeth A. Ashley
• Other Authors: Mahosot Hospital, Lao
• Format: Article
• Published: 2020
• Subjects: Medicine
• Online Access: https://repository.li.mahidol.ac.th/handle/123456789/60581
• Institution: Mahidol University

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...