B1762
Title: Adaptive strategies for clinical trial design
Authors: Sejong Bae - UAB (United States) [presenting]
Abstract: Many study design elements can be considered when planning a clinical trial. Common clinical trial designs include but are not limited to single-arm trials, placebo-controlled trials, noninferiority trials, and designs for validating a diagnostic device. Clinical trial design options depend upon the specific research questions of interest, characteristics of the disease and therapy, the endpoints, the availability of a control group, and other restrictions such as geography. There are many other issues that must be considered when designing efficient clinical trials. Some variation examples that conventional clinical trial design uses to address these challenges are discussed: Biomarker adaptive two-stage design for Phase II, real-world evidence, dynamic enrichment of small sample, sequential, multiple assignment randomized trial (SMART) design.
