Recommendations to improve using Overall Survival data to inform benefit-risk assessments – FDA Oncology

FDA Oncology posted on X about recent paper by Lisa Rodriguez et al., commenting: 

“In a new Clinical Cancer Research paper, FDA’s Lisa Rodriguez, Nicole Gormley and colleagues share best practices, propose novel statistical methodologies, and provide recommendations to improve the rigor of using Overall Survival data to inform benefit-risk assessments.”

Improving Collection and Analysis of Overall Survival Data

Journal: AACR Journals

Author: Lisa R. Rodriguez, Nicole J. Gormley, Ruixiao Lu, Anup K. Amatya, George D. Demetri, Keith T. Flaherty, Ruben A. Mesa, Richard Pazdur, Mikkael A. Sekeres, Minghua Shan, Steven Snapinn, Marc R. Theoret, Rukiya Umoja, Jonathon Vallejo, Nicholas J. H. Warren, Qing Xu, Kenneth C. Anderson

Source: FDA Oncology/X