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Abstract:
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The co-development and co-approval of a therapeutic product and its companion diagnostic assay (CDx) underscores an important paradigm shift for drug developers, diagnostics partners, and regulators. However, development of CDx may be ongoing and therefore it may be unavailable during the drug pivotal clinical trial. Therefore, a clinical trial assay (CTA) may be used instead of CDx for enrolling patients in the clinical trial and a bridging concordance study is generally required to bridge the clinical data from CTA to CDx and to evaluate the drug efficacy in CDx intended use population. In addition, patients may be pre-screened by local test first at the sites and only local test-positive (local+) patients are retested by CTA; i.e., only patients who are CTA+ and local+ are enrolled in the clinical trial. In this presentation, we will discuss statistical challenges in study design and data analysis for bridging study with biomarker-based prescreened samples. Particularly, we provided statistical methods to address prescreening bias and estimate the drug efficacy in CDx intended use population using results from bridging concordance study and CTA-drug pivotal clinical trial.
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