Presentation (CTI)

OBJECTIVES: To provide a stepwise framework for consulting key opinion leaders (KOLs) on prognostic variables (PVs) and treatment effect modifiers (TEMs) during indirect treatment comparisons (ITCs), addressing the lack of standardized procedures for clinical validation of these variables.
METHODS: A structured approach was developed to guide KOL consultations at critical points during the ITC process, including feasibility assessment, analysis, and interpretation. The framework outlines optimal timing, format, and types of questions to present to KOLs for validating PVs and TEMs.
RESULTS: The proposed framework addresses the following key aspects of KOL consultation for ITCs: (1) Timing: Identifies crucial stages in the ITC process where KOL input is most valuable, (2) Format: Suggests effective methods for engaging KOLs and eliciting expert opinions, (3) Question types: Provides guidance on formulating questions that address specific knowledge gaps related to PVs and TEMs.
CONCLUSIONS: This framework offers a systematic approach to KOL consultation for validating PVs and TEMs in ITCs, potentially improving the accuracy and relevance of treatment comparisons in the absence of head-to-head randomized controlled trials. By standardizing the clinical validation process, this approach may enhance the quality and reliability of ITCs, ultimately contributing to more informed treatment guidelines and health technology assessments.