Publications by authors named "Mindy Mo"
An addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in November 2019 introducing the estimand framework. This new framework aims to align trial objectives and statistical analyses by requiring a precise definition of the inferential quantity of interest, that is, the estimand. This definition explicitly accounts for intercurrent events, such as switching to new anticancer therapies for the analysis of overall survival (OS), the gold standard in oncology.
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- - ABP 798 is a biosimilar being tested against rituximab, a treatment for non-Hodgkin lymphoma, in a clinical study called JASMINE, which involved adult patients who had not previously received anti-CD20 therapy.
- - In this study, 256 patients were randomized to receive either ABP 798 or rituximab, with assessments made on their tumor response at specific weeks; results showed that 78.0% of the ABP 798 group and 70.2% of the rituximab group had a positive overall response rate by week 28.
- - Statistical analysis indicated that ABP 798 was clinically equivalent to rituximab, as the
Background: Long-term use of inhaled corticosteroids (ICSs) has been associated with increased risk of bone and ocular comorbidities. We evaluated the effects of the triple fixed-dose combination budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI), formulated using co-suspension delivery technology, on bone mineral density (BMD) and ocular safety in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD).
Methods: In this extension study, a subset of patients from the 24-week, phase III, randomized, double-blind KRONOS study (NCT02497001) continued treatment (BGF MDI 320/18/9.