2026 Peer Review | A Cross-National Review of Novel Oncology Approvals in the United States and China (2020–2025) Read more
2026 Peer Review | Associations between early changes in circulating tumor DNA (ctDNA) and outcomes across randomized trials: Insights from the ctMoniTR project Read more
2026 Peer Review | Assessing contribution of effect in oncology combination therapies: lessons learned to inform and optimize future registrational trial designs Read more
2026 White Paper | Modernizing The FDA Biomarker Qualification Program Strengthening Regulatory Clarity And Broadening Biomarker Use In Drug Development View PDF
2026 Poster | ISPOR 2026 | External Control Arm Feasibility Across External Data Sources in Oncology: Methodological and Regulatory Science Considerations View PDF
2026 Public Comment | Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause View PDF
2026 White Paper | Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors Read more
2026 Public Comment | Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product View PDF
