13 results match your criteria: "The Oncology Center of Excellence[Affiliation]"
When Diversity Goals Meet Multiregional Trials.
N Engl J Med
December 2024
From the Oncology Center of Excellence (G.U.M., R.P.) and the Office of the Commissioner (N.N.B., R.M.C.), Food and Drug Administration, Silver Spring, MD.
Autopsy of a Drug Withdrawal - The Case of Melphalan Flufenamide.
N Engl J Med
December 2024
From the Center for Drug Evaluation and Research (B.K., T.C., N.G.) and the Oncology Center of Excellence (R.P.), Food and Drug Administration, Silver Spring, MD.
The On- and Off-Ramps of Oncology Accelerated Approval.
N Engl J Med
October 2022
From the Office of Oncologic Diseases, Center for Drug Evaluation and Research (L.A.F.-A., G.U.M., J.A.B., R.P.), and the Oncology Center of Excellence (L.A.F.-A, J.A.B., R.P.), Food and Drug Administration, Silver Spring, MD.
Because of significant adaptations forced by the COVID-19 pandemic, resultant changes within health care delivery and clinical research introduced the potential for evaluation of novel evidence generation approaches in oncology. On July 26 and 27, 2021, the National Academies of Science, Engineering, and Medicine, National Cancer Policy Forum hosted a virtual workshop entitled "Cancer Care and Cancer Research in the Context of the COVID-19 Pandemic: A Workshop on Lessons Learned." This workshop examined changes in cancer care and cancer research that occurred in response to the COVID-19 pandemic and considered lessons learned from that experience.
View Article and Find Full Text PDFThe Wild West of Checkpoint Inhibitor Development.
N Engl J Med
April 2022
From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
The Drug-Dosing Conundrum in Oncology - When Less Is More.
N Engl J Med
October 2021
From the Office of Oncologic Diseases (M.S.) and the Division of Cancer Pharmacology II, Office of Clinical Pharmacology (A.R.), Center for Drug Evaluation and Research, and the Oncology Center of Excellence (M.R.T., R.P.), Food and Drug Administration, Silver Spring, MD.
"Dangling" Accelerated Approvals in Oncology.
N Engl J Med
May 2021
From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
Residual Disease after Neoadjuvant Therapy - Developing Drugs for High-Risk Early Breast Cancer.
N Engl J Med
February 2019
From the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (T.M.P., J.A.B.), and the Oncology Center of Excellence (R.P.), Food and Drug Administration, Silver Spring, and the Breast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore (T.M.P., J.A.B.) - both in Maryland.
Metastasis-free Survival - A New End Point in Prostate Cancer Trials.
N Engl J Med
June 2018
From the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (J.A.B.), and the Oncology Center of Excellence (P.G.K., R.P.), U.S. Food and Drug Administration, Silver Spring, MD; and the Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, Washington, DC (J.A.B.).
Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study.
Health Aff (Millwood)
May 2018
Amy P. Abernethy is chief medical officer and chief scientific officer at Flatiron Health.
The majority of US adult cancer patients today are diagnosed and treated outside the context of any clinical trial (that is, in the real world). Although these patients are not part of a research study, their clinical data are still recorded. Indeed, data captured in electronic health records form an ever-growing, rich digital repository of longitudinal patient experiences, treatments, and outcomes.
View Article and Find Full Text PDFLeveraging the Success of HIV Drug Development Paradigms for Cancer.
Clin Cancer Res
June 2018
The Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication.
N Engl J Med
October 2017
From the Office of Hematology and Oncology Products (S.L., P.K.) and the Oncology Center of Excellence (R.P.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Reevaluating Eligibility Criteria - Balancing Patient Protection and Participation in Oncology Trials.
N Engl J Med
April 2017
From the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (J.A.B., G.I., R.P.) and the Oncology Center of Excellence (R.P.), Food and Drug Administration, Silver Spring, MD; and the Breast Cancer Program, Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, Washington, DC (J.A.B.).