A bstract In 2020, Novartis Pharmaceuticals Corporation and the U.S. Food and Drug Administration (FDA) started a 4-year scientific collaboration to find novel radiogenomics-based prognostic and predictive factors for HR+/HER2-metastatic breast cancer under a Research Collaboration Agreement. This manuscript aims to detail the guiding principles and methodology for this study. We include a discussion of internal and external clinical, genomics, imaging datasets, data processing workflows, and machine learning model development strategies. We also prospectively define our success criteria to ensure robust scientific outputs. Disclosure This publication reflects the views of the authors and should not be construed to represent FDA’s views or policies.
Authors: Thibaud Coroller, Berkman Sahiner, Anup Amatya, Alexej Gossmann, Konstantinos Karagiannis, Ravi K. Samala, Luis V. Santana‐Quintero, Nadia Solovieff, Craig Wang, Laleh Amiri‐Kordestani, Qian Cao, H. Kenny, Rosane Charlab Orbach, Frank H. Cross, Tingting Hu, Ruihao Huang, Jeffrey Kraft, Peter Krusche, Yutong Li, Zheng Li, Ilya Mazo, Conor Moloney, Rahul Paul, Jason Plawinski, Susan Schnakenberg, Paolo Serra, Sean Smith, Chi Song, Fei Su, Sajanth Subramaniam, Mohit Tiwari, Colin Vechery, Xin Xiong, Juan Pablo Zarate, Jonathan Ziegler, Hao Zhu, Arunava Chakravartty, Qi Liu, David Ohlssen, Nicholas Petrick, Julie A. Schneider, Mark Walderhaug, Emmanuel Zuber
DOI: https://doi.org/10.1101/2023.08.30.23294367
Publish Year: 2023
