Organization
Center for Drug Evaluation and Research
11 abstracts
Abstract
Underrepresentation of Asian Americans, Native Hawaiians, and other Pacific Islanders (AA & NHPI) in cancer clinical trials that led to FDA approvals in 2010-2022.Org: Center for Drug Evaluation and Research, Oncology Center of Excellence, U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health,
Abstract
Patient-reported outcomes corresponding to most common symptomatic adverse events in lung cancer clinical trials.Org: Oncology Center of Excellence, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Oncologic Diseases, Office of New Drugs,
Abstract
U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022.Org: U.S. Food and Drug Administration, Oncology Center of Excellence, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research,
Abstract
FDA analysis of immune checkpoint inhibitors in combination with vascular endothelial growth factor tyrosine kinase inhibitors in the second-line treatment of patients with advanced non-small cell lung cancer.Org: U.S. Food and Drug Administration, Silver Spring, MD, Office of Oncologic Diseases, Center for Drug Evaluation and Research, Oncology Center of Excellence,
Abstract
Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks.Org: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Oncology Center of Excellence,
Abstract
Trends in U.S and global patient enrollment from 2014 to 2022 in lung cancer clinical trials supporting marketing applications: An FDA analysis.Org: Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Oncology Center of Excellence,
Abstract
Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals.Org: FDA/CDER, U.S. Food and Drug Administration, US Food and Drug Administration, Oncology Center of Excellence, Office of New Drugs,
Abstract
FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma.Org: US Food and Drug Administration, Silver Spring, MD, FDA/CDER, Center for Drug Evaluation and Research, U.S. Food and Drug Administration,
Abstract
FDA analysis of toxicity profiles of oral TKIs recently approved for non-small cell lung cancer based on receipt of prior immune checkpoint inhibitor therapy.Org: United States Food and Drug Administration, Center for Drug Evaluation and Research, Oncology Center of Excellence,
Abstract
Enrollment representation of age, race, and ethnicity in ovarian cancer registrational clinical trials (2010-2020): An evaluation by the U.S. Food and Drug Administration.Org: Oncology Center of Excellence, Office of the Commissioner, U.S. Food and Drug Administration, Office of Biostatistics and Epidemiology, Center for Drug Evaluation and Research,
Abstract
Symptomatic adverse events in lung cancer clinical trials included in US drug labels from 2015 to 2021 to inform patient-reported outcomes.Org: Oncology Center of Excellence, U.S. Food and Drug Administration, ORISE Fellow, Center for Drug Evaluation and Research, Office of Oncologic Diseases,