Results for 'adverse events'
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
Laura A. Levit, Raymond P. Perez, David C. Smith, Richard L. Schilsky, Daniel F. Hayes, and Julie M. Vose
Streamlining Adverse Events Reporting in Oncology: An American Society of Clinical Oncology Research Statement
oncology, research, reporting, adverse events, clinical trials
Monitoring patient safety during clinical trials is crucial to protect research participants and future patients. Under current regulations for investigational new drugs (INDs), sponsors must report certain serious adverse events (AEs) to the FDA and all participating investigators quickly.…
Feb 20th • 3 mins read
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe
Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…
Aug 1st • 45 mins read
Jason J. Yang, BS Naomi So, MD Nolan J. Maloney, MD Julia Arzeno, MD Katherine K. Clifton, MD Daniel Q. Bach, MD, MPH
Inadequate and delayed characterization of cutaneous reactions for US Food and Drug Administration-approved oncologic drugs from 2011-2020 leading to medication discontinuation
cutaneous, cutaneous reactions, FDA, oncologic drugs, AE, CenterWatch
Half of clinical trials lack detailed descriptions of rashes; over half discontinue therapy due to rash. There's a 1- to 2-year delay from identifying a rash to fully characterizing it, although this has improved over the last decade. Oncologic therapies are often discontinued without consulti…
Oct 23rd • 4 mins read
Emerson Y. Chen, MD, Vikram Raghunathan, MD, Vinay Prasad, MD, MPH
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
FDA, RR, drug approvels, OS
Many cancer drugs come to market based on single-arm studies with modest RRs. Most of these drugs are tested in studies of over 100 patients prior to approval. Most (60%) of these approvals lack randomized clinical trials during the life cycle of the product. Our findings suggest greater room for th…
May 28th • 5 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Oncology, Clinical Development, Targeted Therapy, Immunotherapy, Genomic Profiling, CAR-T Cell Therapy, Precision Medicine
Real-world evidence (RWE) complements traditional randomized controlled trials by providing insights from diverse data sources, helping healthcare decision-makers with coverage, reimbursement, and treatment guidelines. Artificial intelligence (AI) and natural language processing (NLP) are pivotal…
Aug 22nd • 5 mins read