Companion diagnostics and clinical development in oncology: a statistical perspective
September 17, 2020
IDDI Complimentary Webinar on the need for integration of biomarker and IVD validation in clinical development
Drug development in many diseases is now shifting towards molecularly targeted treatments that often rely on prognostic and predictive biomarkers for their application. Confronted with such major breakthroughs in the evolution toward personalized or precision medicine, the analytical and clinical validation of biomarkers and their eventual registration as in-vitro diagnostic devices (IVD) and companion diagnostic has received more attention recently.
- This webinar provided a discussion around the need for integration of biomarker and IVD validation in clinical development, with a focus in oncology and companion diagnostics.
- It highlighted how flawed analytical and/or clinical validation can jeopardize a biomarker’s and drug’s clinical utility and showcase why biomarkers deserved statistical rigor throughout the development and validation process.