BATPC Trial Endpoint Description: For Use in Clinical Trial Protocols, Statistical Analysis Plans, and Regulatory Submissions

This document provides ready-to-use protocol and statistical analysis plan (SAP) language for incorporating the Biology-Anchored Tumor Progression Classification (BATPC) as an exploratory secondary endpoint in clinical trials. Includes formal endpoint definition, all ten published BATPC phenotype definitions, suggested protocol text, suggested SAP language, and RECIST concordance guidance. Designed for use by clinical trial protocol writers, statisticians, CRF designers, and regulatory affairs professionals in immunotherapy and targeted therapy trials. Companion to the primary publication: Gupta YK. BATPC: A Biology-Anchored Tumor Progression Classification for Interpreting Multidimensional Progression Phenotypes Across Solid Tumors. Current Problems in Cancer. 2026. DOI: 10.1016/j.currproblcancer.2026.101316 Also see: BATPC FHIR and RWE Implementation Specifications. Zenodo. DOI: 10.5281/zenodo.21611783 Independent research. No external funding received.