Baxter D Evaluating the case for trivalent or quadrivalent influenza vaccines. Hum Vaccin Immunother. 2016 Oct 2;12(10):2712-2717. doi: 10.1080/21645515.2015.1091130. Epub 2016 Jul 19.
Ison MG, Portsmouth S, Yoshida Y, Shishido T, Mitchener M, Tsuchiya K, Uehara T, Hayden FG Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020 Oct;20(10):1204-1214. doi: 10.1016/S1473-3099(20)30004-9. Epub 2020 Jun 8.
Lee N, Ison MG Diagnosis, management and outcomes of adults hospitalized with influenza. Antivir Ther. 2012;17(1 Pt B):143-57. doi: 10.3851/IMP2059. Epub 2012 Feb 3.
Marois C, Nedelec T, Pelle J, Rozes A, Durrleman S, Dufouil C, Demoule A Comparison of Clinical Profiles and Mortality Outcomes Between Influenza and COVID-19 Patients Invasively Ventilated in the ICU: A Retrospective Study From All Paris Public Hospitals From 2016 to 2021. Crit Care Explor. 2022 Jul 25;4(7):e0737. doi: 10.1097/CCE.0000000000000737. eCollection 2022 Jul.
Mombelli M, Kampouri E, Manuel O Influenza in solid organ transplant recipients: epidemiology, management, and outcomes. Expert Rev Anti Infect Ther. 2020 Feb;18(2):103-112. doi: 10.1080/14787210.2020.1713098. Epub 2020 Jan 18.
Neuberger E, Wallick C, Chawla D, Castro RC Baloxavir vs oseltamivir: reduced utilization and costs in influenza. Am J Manag Care. 2022 Mar 1;28(3):e88-e95. doi: 10.37765/ajmc.2022.88786.
O'Hanlon R, Shaw ML Baloxavir marboxil: the new influenza drug on the market. Curr Opin Virol. 2019 Apr;35:14-18. doi: 10.1016/j.coviro.2019.01.006. Epub 2019 Mar 8.
Paules C, Subbarao K Influenza. Lancet. 2017 Aug 12;390(10095):697-708. doi: 10.1016/S0140-6736(17)30129-0. Epub 2017 Mar 13.
Shirley M Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza. Drugs. 2020 Jul;80(11):1109-1118. doi: 10.1007/s40265-020-01350-8.
Tsang TK, Lau LLH, Cauchemez S, Cowling BJ Household Transmission of Influenza Virus. Trends Microbiol. 2016 Feb;24(2):123-133. doi: 10.1016/j.tim.2015.10.012. Epub 2015 Nov 21.
Vanderlinden E, Naesens L Emerging antiviral strategies to interfere with influenza virus entry. Med Res Rev. 2014 Mar;34(2):301-39. doi: 10.1002/med.21289. Epub 2013 Jun 25.
A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.