Identifying, Selecting, and Utilizing Quantitative Bias Analysis Methods

The project was co-directed by Drs. Zeyan Liew and Dr. Joshua D. Wallach and funded by the Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI). The Yale team collaborated with the FDA to (1) systematically identify, summarize, and compare quantitative bias analysis (QBA) approaches, and (2) develop a user-friendly decision matrix that will allow investigators to identify QBA methods based on different study characteristics. The information generated in the project will guide the use of the QBA methods in regulatory sciences.