We look forward to welcoming WNAR 2024 attendees to the joint WNAR/Graybill conference in Fort Collins starting this Sunday, June 9! We would like to highlight two special talks:

• Robert L. Santos, Director of the U.S. Census Bureau, will be giving the WNAR Plenary and Presidential Address "Serving Through Leadership: My Approach to Heading a Federal Statistical Agency" on Monday June 10 at 8:45am.
• Scott Evans, Professor, George Washington University, will be giving the Graybill Keynote "The order of operations is important: It is time to correct the clinical trial arithmetic" on Tuesday June 11, at 8:30am

Abstracts:

Robert L. Santos, Director of the U.S. Census Bureau

Serving Through Leadership: My Approach to Heading a Federal Statistical Agency

 

This talk will present my approach to leading the largest federal statistical agency in the United States, and how I came to be the leader that I am. By telling my personal and professional story, I'll show how becoming a leader can be much more than learning the art of decision making or learning techniques to herd cats. Based on my personal experience, I believe that virtually every person can grow into a competent, sage leader. Your leadership journey transcends whether you are an introvert or extrovert, whether you are a mathematical statistician, a data scientist or an applied statistician or anything else. Everything about you affects who you are as a leader, and to be effective, you need to bring your "whole self" to the table -- not just your education and technical expertise, but your life experience, culture, values and aspirations. Becoming a leader is necessarily a never-ending growth process, one that has to come from within you.

Dr. Scott Evans, Professor and Founding Chair of the Department of Biostatistics and Bioinformatics and the Director of The Biostatistics Center at Milken Institute School of Public Health of the George Washington University.

The order of operations is important: It is time to correct the clinical trial arithmetic

Typically in clinical trials efficacy and safety are evaluated in silos, one outcome at a time. However this approach: fails to incorporate associations between or the cumulative nature of multiple outcomes in individual patients, suffers from competing risk complexities during interpretation of individual outcomes, fails to recognize important gradations of patient responses, suboptimally evaluates treatment effect heterogeneity based on a single endpoint rather than benefit:risk considerations, and since efficacy and safety analyses are often conducted on different populations, generalizability is unclear. In recognition of this, the Council for International Organizations of Medical Sciences (CIOMS) recently recommended: (1) transitioning benefit-risk evaluation as a post-hoc exercise to incorporating benefit-risk considerations into clinical trial design, and (2) a pragmatic patient-centric approach to benefit-risk assessment to ensure proper evaluation of the benefits and harms as experienced by patients. The desirability of outcome ranking (DOOR) is a paradigm for the design, analysis, and interpretation of clinical trials based on a comprehensive patient-centric benefit-risk evaluation developed to address these limitations and the CIOMS recommendations, and advance clinical trial science. In this paradigm outcomes are used to analyze patients rather than patients being used to analyze outcomes. The experiences of trial participants in different treatment arms are compared by the desirability of the overall patient outcome, increasing pragmatism and addressing the most important “real world” question to aid clinical decision-making: how do resulting patient experiences, when comprehensively considering benefits and harms, compare between therapeutic alternatives? The DOOR paradigm, and freely available online tools for design and robust analyses are discussed, and illustrated using examples.