Translating MRD into Regulatory Evidence: Defining the Approval & Adoption Pathway in Solid Tumors
- Addressing analytical and clinical validation standards required to support regulatory review of MRD assays in oncology drug development
- Integrating MRD into trial design to generate evidence packages that enable regulatory qualification as surrogate endpoints
- Aligning regulatory and payer expectations to accelerate acceptance of MRD as a decision-making tool in routine oncology practice