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Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|December 12, 2023
An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022Grace Collins, Brittany McKelvey, Hillary S Andrews, et al.Therapeutic Innovation & Regulatory Science|May 15, 2025
Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for ValidationHillary S Andrews, Grace Collins, Bernat Navarro-Serer, et al.Therapeutic Innovation & Regulatory Science|October 27, 2025
Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification ProgramGrace Collins, Jeff D Allen, Hillary S Andrews, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|June 17, 2024
An Evaluation of Novel Oncology Approvals with a PMR/C for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical TrialsGrace Collins, Hillary S Andrews, Brittany McKelvey, et al.JCO Oncology Advances|June 23, 2025
Impact of the COVID-19 Pandemic Mitigation Strategies on Cancer Treatment Trials: A Meta-Analysis of Industry and National Cancer Institute StudiesJoseph M Unger, Hillary S Andrews, Laura A Levit, et al.Journal for Immunotherapy of Cancer|September 22, 2025
Molecular response cutoffs and ctDNA collection timepoints influence on interpretation of associations between early changes in ctDNA and overall survival in patients treated with anti-PD(L)1 and/or chemotherapyHillary S Andrews, Nevine Zariffa, Katherine K Nishimura, et al.Cytotherapy|April 7, 2024
Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related productsMark D Stewart, Michael Kalos, Vicki Coutinho, et al.Diagnostics (Basel, Switzerland)|May 11, 2024
Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and StagesBrittany A McKelvey, Hillary S Andrews, Frederick L Baehner, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|September 13, 2024
Plasma ctDNA as a Treatment Response Biomarker in Metastatic Cancers: Evaluation by the RECIST Working GroupAlexander W Wyatt, Saskia Litiere, Francois-Clément Bidard, et al.JCO Clinical Cancer Informatics|August 15, 2024
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 ChemotherapyBrittany A McKelvey, Elizabeth Garrett-Mayer, Donna R Rivera, et al.Pageof 2