Haitao Pan, PhD, Assistant Professor in the Department of Biostatistics at the St. Jude Research Hospital will be giving a presentation on “Screened Selection Design (SSD) for Uncontrolled Randomized Phase II Oncology Trials.” This presentation is entirely virtual, and will occur on October 15, 2024, 12:00pm - 1:00pm via Zoom. Registration is required, and upon registration, attendees will received a confirmation email with information about joining the meeting.

ABSTRACT: This talk introduces screening selection design (SSD) for uncontrolled randomized pediatric oncology trials with binary and time-to-event endpoints. The absence of a control arm is a characteristic of SSD trials; however, it can facilitate direct comparison between different treatment arms through the selection stage within SSD. From our perspective, SSD trials occupy an intermediate position between separate single-arm trials and multi-arm trials with a control group. SSD should serve as a valuable tool for studying rare diseases or conducting studies with limited sample size available, particularly in the proof-of-concept stage of drug development. We will introduce two St. Jude pediatric oncology trials utilizing the SSD methods: one in pediatric neuroblastoma and the other in pediatric Ewing sarcoma. The chapter will discuss the methodology and implementation of screening selection designs using the R packages frequentistSSD and frequentistSSDBinary.