The Use of BOIN Design in Practice: What We Have Learned

• Activity Number: 403 - SPAAC Poster Competition
• Type: Topic Contributed
• Date/Time: Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Suyu Liu* and Heather Lin and Lei Feng and Xuemei Wang
• Companies: University Of Texas M.D. Anderson Cancer Center and MD Anderson Cancer Center and MD Anderson Cancer Center and MD Anderson Cancer Center
• Keywords: BOIN; dose-finding; clinical trial; phase I

Abstract

The Bayesian optimal interval (BOIN) design has been widely used in phase I clinical trials. By casting dose finding as a decision-making problem, BOIN design provides the optimal boundaries for dose-finding studies to minimize the probability of inappropriate dose assignment for patients. BOIN design has been applied in various cancer types, such as breast cancer, myeloma/lymphoma, melanoma, and leukemia. It has also been applied in various treatments, including chemotherapy, radiation therapy, biological target therapy, and immunotherapy. BOIN design is easy to implement in a way similar to 3+3 design, but it is more flexible in terms of cohort size and target toxicity rate. BOIN design yields comparable or better performance compared to more complex model-based designs. Therefore, BOIN design is chosen by the needs of phase I clinical trial conduct and has been more and more used in the practice.