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DIA/FDA Biostatistics Industry and Regulator Forum
Session 1: COVID-19 Treatments and Vaccines: Statistical Challenges and Lessons Learned
Brenda Crowe, PhD
- Senior Research Advisor, Global Statistical Sciences
- Eli Lilly and Company, United States
Shiowjen Lee, PhD
- Deputy Director, Division of Biostatistics, OBE, CBER
- FDA, United States
The COVID-19 pandemic brought many challenges to sponsors and regulatory bodies wishing to develop vaccines and/or treatments for COVID-19. It was imperative to work at top speed and the standard of care was changing rapidly. The FDA has issued Emergency Use Authorization (EUA) for both vaccines and treatments. This session will include case studies that highlight particular issues of COVID-19 clinical development and how they were dealt with by sponsors and the FDA. Speakers will discuss the statistical issues and solutions to handle the unprecedented uncertainty and changing dynamics.
Learning Objective :
- Describe the considerations in EUA and FDA authorization of COVID-19 vaccines
- Discuss data quality derived from on-going placebo-controlled COVID-19 vaccine trials and the degree of protection received from vaccines
- Describe the unique statistical issues in the design of COVID-19 treatment and vaccine trials
- Describe potential statistical solutions to the uncertainty of developing vaccines and treatments in a rapidly changing environment
Designing and Analyzing Studies During an Evolving Pandemic: What Can we Learn for the Future?
Ian Hirsch, PhD
- Respiratory/Infection Biologics and Vaccine Products Biometrics Strategy Lead
- Astrazeneca, United Kingdom
Regulatory Review of EUA and Statistical Issues
Tsai-Lien Lin, PhD
- Chief, Vaccine Evaluation Branch, DB, CBER
- FDA, United States
Building a Plane While Flying It: Reflections on Repurposing a Drug to Treat COVID-19
Yanping Wang, PhD
- GSS, United States