Statistical Considerations in Bridging Study for Companion Diagnostic Clinical Validation

• Activity Number: 237 - Statistical Challenges in Evaluating Molecular Diagnostic Assays Geared Toward Companion Diagnostics Devices
• Type: Topic-Contributed
• Date/Time: Wednesday, August 11, 2021 : 10:00 AM to 11:50 AM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Johan Surtihadi* and Yaji Xu and Kristen Meier and Joanne Lin
• Companies: Illumina and Illumina and Illumina and Illumina
• Keywords: Companion Diagnostic; Clinical Validation; Bridging Study; Drug-Diagnostic Development

Abstract

Applications in drug-diagnostic device co-development are becoming increasingly prominent. A well-characterized market-ready companion diagnostic (CDx)assay is desired for patient enrollment in device drug pivotal clinical trial(s) so that CDx clinical performance can be demonstrated from the single drug-diagnostic trial directly. However, such a study design may be difficult or impractical. For instance, a clinical trial assay (CTA) instead of the CDx is used for patient enrollment to meet the trial timeline. Hence, a bridging study needs to be conducted to estimate the efficacy of the drug in the population defined by the CDx. In this paper, we will discuss statistical challenges and practical issues in bridging study design and data analysis. Particularly, other than the traditional bridging method based on estimating the drug efficacy for CDx defined sub-population, we aim to provide alternative approaches to demonstrate CDx clinical performance.