All Times EDT
Keywords: Complex Biomarker Based Innovative Designs
Many trial designs in clinical research are employed for drug development and in regulatory applications. In statistical literature, we witness an abundance of methodological advances while the study is ongoing. Depending on the characteristics of diseases and the pharmacological properties of an experimental drug product, a specific biomarker-based trial design may fit for use in one type of applications but may not in other types of applications. In addition, the complexity of trial objectives and study endpoints may further advance trial designs to achieve multiple study objectives. This presentation will give utilities of statistical methodologies for complex biomarker-based innovative designs in clinical development programs and exemplify various challenges when applied in regulatory setting.
*The views in this presentation reflect the views of the author and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.