Results for 'patient self-report'
Browse oncology articles matching patient self-report — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
cancer, pediatrics, product labeling, united states food and drug administration, childhood cancer, denosumab, surrogate endpoints, adverse event, patient self-report, pediatric oncology, selumetinib, benefit-risk assessment, tisagenlecleucel, statistica
PROs have been feasible to collect from patients as young as 7 years old and were included in trials from 2013 onward. PROs were used as exploratory endpoints in four product applications but not included in product labeling. To include PRO data in FDA labeling, early interaction with the FDA, c…
Apr 30th • 12 mins read
David J. Segarnick, PhD Chief Medical Officer, Educational Resource Systems Adjunct Associate Professor, Rutgers New Jersey Medical School Department of Pharmacology, Physiology & Neuroscience David E. Wazer, MD, FACRO, FABS, FACR, FASTRO Research Scholar
From Genomic Testing to Digital Biomarkers: The Expanding Role of Biomarkers in Oncology
oncology biomarkers, precision oncology, predictive biomarkers
Biomarkers have moved from the margins of oncology to the center of clinical decision-making. They now help establish diagnosis and prognosis, identify patients most likely to benefit from targeted therapy or immunotherapy, monitor response, detect molecular residual disease and emerging resistance,…
Aug 20th • 35 mins read