The New Era of CDx in Oncology: Adapting Clinical Research Strategy to Evolving Regulations

In oncology, companion diagnostics (CDx) are crucial for identifying patients who are most likely to benefit from a particular cancer therapy based on their biomarker status. This personalized approach enhances targeted patient selection, treatment efficacy, minimizes adverse effects, and contributes to more efficient clinical trials by focusing on defined patient populations.

With the increase in the application of CDx in oncology therapeutic development, regulatory scrutiny has intensified. Beginning May of 2025, manufacturers will face more stringent requirements for analytical and clinical validation of laboratory-developed tests (LDTs), including CDx. This shift in regulatory requirements may demand additional resources, lengthen development timelines, and increase operational complexity.

In this webinar, the expert speakers will explore the shifting landscape of CDx in oncology, highlighting key regulatory, assay development and study design considerations for biomarker-guided clinical trials.

Keywords: Clinical Trials, Drug Development, Clinical Research, Oncology, Medical Devices, Diagnostics, Medical Device Regulation, Therapeutic Areas, MDR, Clinical Trial Regulation

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Life Sciences,Pharma,Drug Discovery & Development,Medical Device