Peer Review | A Cross-National Review of Novel Oncology Approvals in the United States and China (2020–2025)
White Paper | 2024 Annual Meeting | Enhancing Study Designs and Interpretation of Interim Overall Survival Data in Oncology Trial
White Paper | 2024 Annual Meeting | Framework for Integrating Change in ctDNA Levels in Advanced Cancer Clinical Trials to Support Meta-analyses for Intermediate Endpoint Validation
Public Comment | Clinical Trial Considerations To Support Accelerated Approval of Oncology Therapeutics
Public Comment | Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
White Paper | Accelerating Investigation of New Therapies in Earlier Metastatic Treatment Settings
Peer Review | Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies
The breakthrough therapy designation (BTD) process was created to expedite clinical development timelines for drugs intended to treat serious conditions and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies. This analysis demonstrates that BTD is a valuable tool for expediting approval of promising therapies in oncology. By comparing drugs indicated…
White Paper | Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation
Peer Review | Expedited Development Programs at the Food and Drug Administration: Insights and Opportunities
Timely access to therapies that treat serious illnesses is critical for patients, particularly for those with rare or serious disease types that have no current treatments. Congress and the Food and Drug Administration (FDA) have addressed this by periodically establishing programs designed to expedite different steps associated with the development and review of drugs and…