Statistical justification of expansion cohorts in phase 1 cancer trials
Sign Up to like & getrecommendations! Published in 2018 at "Cancer"
DOI: 10.1002/cncr.31577
Abstract: Phase I cancer trials increasingly incorporate dose‐expansion cohorts (DECs), reflecting a growing demand to acquire more information about investigational drugs. Protocols commonly fail to provide a sample‐size justification or analysis plan for the DEC. In… read more here.
Keywords: cancer; phase cancer; expansion cohorts; cancer trials ... See more keywords
Adverse events (AEs) in early phase cancer clinical trials.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2018.36.15_suppl.2542
Abstract: 2542Background: AE reporting is required in the conduct of clinical trials for patient safety and to understand the toxicities from treatment interventions. This analysis used a uniquely comprehens... read more here.
Keywords: early phase; aes early; clinical trials; adverse events ... See more keywords
A Brief Overview of Adaptive Designs for Phase I Cancer Trials
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DOI: 10.3390/cancers14061566
Abstract: Simple Summary Phase I cancer trials are important for new drug developments to test the safety and optimal dosage of cancer drugs which are usually toxic. Understanding biostatistical methodologies of these designs is important for… read more here.
Keywords: brief overview; cancer trials; adaptive designs; phase cancer ... See more keywords