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SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote trans...

Dostarlimab plus chemotherapy elicited a higher objective response rate and showcased a numerical improvement in overall survival compared with pembrolizumab and chemotherapy in patients with treatment-naïve, nonsquamous non–small cell lung cancer.

In a population-based, sibling-controlled cohort study Jiangwei Sun and colleagues explore the long-term risk of arrhythmias in patients with inflammatory bowel disease.

/PRNewswire/ -- DelveInsight's Cholangiocarcinoma Market Insights report includes a comprehensive understanding of current treatment practices,...

- Evaluation of IOS-1002, a LILRB1 (ILT2), LILRB2 (ILT4), KIR3DL1 targeting agent, in combination with KEYTRUDA® (pembrolizumab) as part of ongoing Phase 1a/b trial in advanced solid tumors