Tuesday, February 8, 2022
1:00pm Eastern Time
Elizabeth Garrett-Mayer, PhD, FSCT
Vice President
Center for Research and Analytics (CENTRA)
Dr. Garrett-Mayer joined ASCO in 2017 as CENTRA’s Division Director for Biostatistics and Research Data Governance and became CENTRA’s first Vice President in 2022. CENTRA leads ASCO’s research efforts, including the TAPUR Study, ASCO’s COVID-19 Registry, and research projects aimed at increasing minority enrollment and expanding eligibility criteria in clinical trials. Prior to joining ASCO, she served on the faculty in the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in the Department of Oncology, and then joined the faculty of the Medical University of South Carolina (MUSC) and established the Biostatistics Shared Resource at the Hollings Cancer Center (HCC).
She earned her bachelor’s degree from Bowdoin College in Math and Economics, and a PhD in Biostatistics from Johns Hopkins Bloomberg School of Public Health. Her publication record includes more than 280 peer-reviewed publications, primarily in cancer research and research methods. She has also been a member of numerous NIH grant review committees, Data Safety Monitoring Boards for NIH-supported clinical trials and has served on the editorial board of three peer-reviewed journals (Clinical Trials, Cancer, and the Journal of the National Cancer Institute), and as faculty on the ASCO/AACR Methods in Clinical Cancer Research Workshop for over a decade.
Abstract:
Uncertainty about optimality of doses of anti-cancer agents approved in recent years, including PD-L1 blockade agents and targeted agents, has led to a movement in the oncology drug development field to reconsider the traditional approach for drug development. Following in the path of approvals for nivolumab and pembrolizumab, trial designs for dose finding trials have ballooned from sample sizes in the range of 12-50 to the hundreds or more. In addition, post-marketing trials have demonstrated that lower doses of certain drugs may be as efficacious as approved doses. The has contributed to a renewed focus on ‘dose optimization,’ causing statisticians, researchers, patient advocates and regulators to realize the profound inadequacies of traditional phase I dose finding designs. Trial approaches need to incorporate the adaptive nature of a seamless toxicity-efficacy paradigm, while maintaining practical aspects of trial implementation, statistical properties, endpoint measurement and safety and well-being of patients. This talk will discuss these aspects and provide recent context of drug approvals in oncology.
