Ordinal Endpoints in Clinical Trials

Featuring Dr LaRee Tracy, Biometrics Director at PHASTAR

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Abstract: 'Ordinal endpoints in clinical trials. An exploration into their construction and interpretation with recent examples from RCTs in severe influenza and COVID-19'.

Ordinal endpoints are often meaningful endpoints as they represent the ordered, exhaustive set of mutually-exclusive clinical states for a particular disease or condition. Despite advantageous statistical properties, ordinal endpoints are less common in clinical trials compared to endpoints measured on a continuous or dichotomous scale largely due to challenges in analyses and interpretation. More recently; however, these endpoints have been introduced into clinical trials studying treatments for severe influenza and COVID19 with variable success. This talk with discuss key concepts associated with ordinal outcomes, the statistical advantages and disadvantages, and highlights from current and completed clinical trials testing these endpoints.

About the speaker:

Dr. LaRee Tracy is a Director of Biostatistics leading the PHASTAR office located in San Diego, CA providing an array of clinical research services including trial design and analyses and understanding regulatory processes and requirements. Prior to joining PHASTAR, Dr. Tracy worked as a mathematical statistician at the US FDA where she was intimately involved in all aspects of regulatory review and new drug approvals in infectious and rare diseases, drug safety, and pharmacoepidemiology. Dr. Tracy earned a PhD in epidemiology and a masters degree in mathematical statistics is a part-time lecturer at San Diego State University. Her interests include design of confirmatory clinical trials, endpoint selection and validation, use of observational and other real world data in drug development, and the drug/biologic regulatory process.

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