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Activity Number: 238 - SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation
Type: Contributed
Date/Time: Monday, July 30, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #329712 Presentation
Title: Statistical Considerations for Bridging Studies in Precision Medicine Programs with Drug-Device Co-Development
Author(s): Shunguang Wang* and Meijuan Li and Xiaohong Li and Jincao Wu and Robinson Douglas
Companies: Novartis Analytics and FDA and Novartis Analytics and CDRH/US. Food and Drug Adminstration and Novartis Pharmaceuticals
Keywords: Precision medicine; companion diagnostics; bridging study; drug-device co-development

The success of precision medicine relies on analytically and clinically validated companion diagnostics (CDx) to identify patients most likely to benefit from the treatment or run at increased risk of adverse events. It also permits monitoring of patient response to inform treatment or dosage adjustments. CDx is required to be validated in the pivotal clinical trials for the corresponding therapeutics in device-drug co-development programs. Ideally the CDx is used to enroll patients for the pivotal clinical trial. Various challenges, however, may lead to using a prototype CDx, so-called clinical trial assay (CTA) for enrolling patients while the CDx is undergoing extensive development and robust analytical validation. The clinical efficacy of the CDx will then need to be demonstrated using the CTA-enrolled patients in a bridging study by re-testing available leftover specimens from the original clinical trial. This presentation introduces the statistical considerations involved in a typical bridging study. It highlights the associated statistical challenges and methods used to address these challenges based upon the approval of CDx for therapies developed at Novartis Oncology.

Authors who are presenting talks have a * after their name.

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