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… Oncology Estimand Working Group of ASA BIOP & PSI/EFSPI. 10:25-10:55 am EST Introduction to the ICH E9(R1) estimand and …
… MS, is a Director of Biostatistics at RTI-HS. She has over 10 years of professional experience providing statistical and … include metabolic disorders (obesity, metabolic syndrome), oncology (breast cancer, colorectal cancer, lung …
JCA Strategy and Planning The launch of Joint Clinical Assessments in 2025 represents a significant change to the marketing authorization process in the EU. It is critical that drug and device developers become informed on the latest guidance to be …
… noninterventional, multicenter longitudinal study of US patients that included patient chart abstractions and patient …
… M, Park B, Dubinsky M. Poster Tuesday October 24, 2023 10:30 AM – 4:00 PM …
SIGMA Stakeholder Announcement Share on: January 15, 2021 Launch of the SIGMA Consortium heralds a new era of collaboration to better understand safety and effectiveness of medical interventions. Research institutions compete for resources to carry out …
… various therapeutic areas, including cardiology, thoracic surgery, oncology, rare diseases, pulmonology, vaccines, …
… 2022). Health-related quality of life and tolerability in patients with/without skin toxicity during loncastuximab …
… SH. Surgical resection, treatment patterns and outcomes in patients (pts) with early-stage non-small cell lung cancer …
… measured by the PRO instrument should be meaningful to patients. Consideration should also be given to aspects of a given concept that may be important to patients (e.g., frequency, severity, interference with … activities of daily living). The agency recognizes that patients may prioritize some concepts over others (for …