All Times EDT
Keywords: therapeutic and CDx products, IVD bridging study, CDx, CTA, concordance analysis
A well characterized market-ready companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that the company can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, using CDx for the clinical trial enrollment may be difficult or impractical. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in the clinical trial. A concordance study (or bridging study) will be required to assess the agreement between CDx and CTA in order to bridge the clinical data (e.g. overall survival) from CTA to CDx and to evaluate the drug efficacy in CDx intended use population. In this talk, we will provide an overview of the challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial. We will discuss the types of bridging study, clinical endpoint, CDx missing data on the impact on the bridging study efficacy analysis.