Multiplicity considerations in clinical trials

A Dmitrienko, RB D'Agostino Sr - New England Journal of …, 2018 - Mass Medical Soc
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Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC

MA Socinski, RM Jotte, F Cappuzzo… - … England Journal of …, 2018 - Mass Medical Soc
Background The cancer-cell–killing property of atezolizumab may be enhanced by the
blockade of vascular endothelial growth factor–mediated immunosuppression with …

[HTML][HTML] Empagliflozin in patients post myocardial infarction rationale and design of the EMPACT-MI trial

J Harrington, JA Udell, WS Jones, SD Anker… - American Heart …, 2022 - Elsevier
Background Patients with acute myocardial infarction (MI) are at risk for developing heart
failure (HF) and subsequently are at an increased risk of mortality. Sodium-glucose …

Advances in p-value based multiple test procedures

AC Tamhane, J Gou - Journal of biopharmaceutical statistics, 2018 - Taylor & Francis
In this article we review recent advances in-value-based multiple test procedures (MTPs).
We begin with a brief review of the basic tests of Bonferroni and Simes. Standard stepwise …

[HTML][HTML] Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled …

CM Gibson, JJP Kastelein, AT Phillips, PE Aylward… - American heart …, 2021 - Elsevier
Acute myocardial infarction (MI) patients remain at high risk for recurrent events. Cholesterol
efflux, mediated by apolipoprotein AI, removes excess cholesterol from atherosclerotic …

Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study

SV Parikh, ST Aaronson, SJ Mathew, G Alva… - …, 2024 - nature.com
Major depressive disorder (MDD) is a mental health disorder that can cause disability and
functional impairment that standard-of-care (SOC) antidepressant therapies (ADTs) can take …

[HTML][HTML] Development and validation of a spontaneous preterm delivery predictor in asymptomatic women

GR Saade, KA Boggess, SA Sullivan… - American journal of …, 2016 - Elsevier
Background Preterm delivery remains the leading cause of perinatal mortality. Risk factors
and biomarkers have traditionally failed to identify the majority of preterm deliveries …

Traditional multiplicity adjustment methods in clinical trials

A Dmitrienko, R D'Agostino Sr - Statistics in Medicine, 2013 - Wiley Online Library
This tutorial discusses important statistical problems arising in clinical trials with multiple
clinical objectives based on different clinical variables, evaluation of several doses or …

[HTML][HTML] Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized …

SL Watson, LW Jones, F Stapleton, M Hinds, A Ng… - The Ocular Surface, 2023 - Elsevier
Purpose Meibomian gland dysfunction (MGD) is a chronic progressive disease with
downstream effects on ocular signs and symptoms. AZR-MD-001 is a selenium sulfide …

Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial

NM Ivers, JD Schwalm, Z Bouck, T McCready… - bmj, 2020 - bmj.com
Objective To test a scalable health system intervention to improve long term adherence to
secondary prevention treatments among patients who have had a recent myocardial …