Peer Review | Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality
Peer Review | Bridging research and practice: enhancing regulatory decisions with pragmatic clinical trials in oncology
Peer Review | Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Chemotherapy
Peer Review | An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials
Peer Review | Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages
Peer Review | Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products
Peer Review | An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012–2022
Peer Review | A National Assessment of Diagnostic Test Use for Patients with Advanced NSCLC and Factors Influencing Physician Decision-Making
Background Diagnostic tests, including US Food and Drug Administration (FDA)-approved tests and laboratory-developed tests, are frequently used to guide care for patients with cancer, and, recently, have been the subject of several policy discussions and insurance coverage determinations. As the use of diagnostic testing has evolved, stakeholders have raised questions about the lack of standardized…
Peer Review | Real-world Overall Survival Using Oncology Electronic Health Record Data: Friends of Cancer Research Pilot
Randomized controlled trials (RCTs) evaluate the safety and efficacy of medical products in specific patient populations under rigorously controlled conditions. While adherence to structured protocols, use of restrictive eligibility criteria, and patient randomization maximize the internal validity of RCT results, eligibility and protocol-directed care may reduce the relevancy of study results for broader patient populations…
