Confirmed Best Overall Response (BOR) in Oncology Trials: Why Precise RECIST Programming Matters

In oncology clinical development, tumor response endpoints influence some of the most critical decisions in a program’s lifecycle.  

Among these, Best Overall Response (BOR) plays a central role in early-phase trials where response is the primary endpoint. Even in later development stages, confirmed BOR continues to provide valuable supportive insights, despite not functioning as a formal primary endpoint. 

Yet, deriving confirmed BOR is far from straightforward. While RECIST 1.1 establishes a standardized framework for tumor response assessment, real-world clinical trial data often introduces complexities not explicitly addressed in the guideline. Accurate implementation requires more than standard endpoint programming.   

This white paper explores the nuances behind confirmed BOR derivation, highlighting the programming and interpretation challenges sponsors face and the importance of robust, reproducible oncology response frameworks. 

Key Topics: 

• RECIST 1.1: The foundation of tumor response analysis
• Best overall response: More than just a single value
• The challenge of implementing confirmation logic in real-world data
• Example scenarios: How confirmation rules affect BOR
• Why confirmed BOR is critical for early-phase decision-making

Authors: 

Ilona Reding, Principal Statistical Programmer 

Guillaume Hervé, Director, Statistical Programming 

Ophélie Calas-Zeroug, Associate Director of Biostatistics

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