All Times EDT
Keywords: Companion Diagnostic assay (CDx), Clinical trial assay (CTA), Bridging Study, Low prevalence
A well characterized market -ready companion diagnostic assay (CDx) is important for the safe and effective use of various therapeutic products. A market-ready CDx is desired for patient enrollment in device-drug pivotal clinical trial(s) so that Food and Drug Administration can ensure appropriate clinical and analytical validation studies are planned and conducted for CDx. However, this is often met with difficulty as often a clinical trial assay (CTA) instead of a CDx is used for patient enrollment in clinical trial(s). Thus, a concordance study or a bridging study is essential to assess the agreement between CDx and CTA to bridge clinical trial data from CTA to CDx and to evaluate the drug efficacy in CDx intended use population. There are common challenges in such bridging studies, namely, prevalence being low or that multiples CTAs involved in enrollment. In this roundtable, we will discuss some of the statistical challenges associated with such bridging studies.