Related Experiment Video
Updated: Sep 24, 2025

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction
Published on: January 29, 2019
Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and
Weidong Zhang1, Sunhee Ro2, Qi Jiang3
1Jounce Therapeutics, Inc., Cambridge, MA, USA. wzhang1001@yahoo.com.
Abstract:
In biomarker enrichment study designs that start with an all-comer population, simultaneous evaluation of the entire and the marker-selected populations can be more desirable than pre-specifying the testing order, when the degree of marker predictiveness is uncertain. While there has been substantial research on this approach, our goal is to provide a complete overview and guidance in all aspects of this approach, including the interim analysis potentially using different endpoints, combination tests with associated multiplicity control, and the final treatment effect estimation. Regulatory/operational aspects and actual cases demonstrating the potential advantage of this approach are also described.
Related Concept Videos
Comparing the Survival Analysis of Two or More Groups
Cancer Survival Analysis
Assumptions of Survival Analysis
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Actuarial Approach
Consider the example of a high-risk surgical procedure with significant early-stage mortality. A two-year clinical study is conducted,...
Kaplan-Meier Approach

