Search Results - "Liu, Jeen"
-
1
Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities
Published in Therapeutic innovation & regulatory science (01-09-2018)“…The goal of clinical trial research is to deliver safe and efficacious new treatments to patients in need in a timely and cost-effective manner. There is…”
Get more information
Journal Article -
2
Omalizumab is effective in the long-term control of severe allergic asthma
Published in Annals of allergy, asthma, & immunology (01-08-2003)“…Previous reports show that addition of omalizumab to standard therapy reduces asthma exacerbations and simultaneously decreases use of inhaled corticosteroids…”
Get more information
Journal Article -
3
Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
Published in Contemporary clinical trials communications (01-09-2018)“…Abstract This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint…”
Get full text
Journal Article -
4
OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females
Published in International clinical psychopharmacology (01-01-2020)“…This 24-week double-blind placebo-controlled multicenter randomized phase 2 trial evaluated efficacy and safety of onabotulinumtoxinA (onabotA; BOTOX) vs…”
Get full text
Journal Article -
5
Design of randomized controlled confirmatory trials using historical control data to augment sample size for concurrent controls
Published in Journal of biopharmaceutical statistics (04-05-2019)“…This paper deals with the methods to augment concurrent controls (CC) in a randomized controlled trial with available historical data in clinical studies. In…”
Get full text
Journal Article -
6
Causal inference for longitudinal data based on historical controls
Published in Journal of biopharmaceutical statistics (04-05-2023)“…Use of historical data has become a hot topic recently, considered to provide a way to reduce patient burden, lower drug development cost, and make innovative…”
Get full text
Journal Article -
7
Evaluation of alternative confidence intervals to address non‐inferiority through the stratified difference between proportions
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01-01-2021)“…SUMMARY The confidence interval (CI) for the difference between two proportions has been an important and active research topic, especially in the context of…”
Get full text
Journal Article -
8
Evaluation of alternative confidence intervals to address n on‐inferiority through the stratified difference between proportions
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01-01-2021)“…SUMMARY The confidence interval (CI) for the difference between two proportions has been an important and active research topic, especially in the context of…”
Get full text
Journal Article -
9
Treating major depressive disorder with onabotulinumtoxinA: Safety and efficacy 24 weeks following a single injection session
Published in Toxicon (Oxford) (01-12-2018)Get full text
Journal Article -
10
Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety
Published in Therapeutic innovation & regulatory science (01-11-2018)“…In clinical studies for disorders such as rheumatoid arthritis, type 2 diabetes mellitus, multiple sclerosis, osteoporosis, etc, sometimes the developers need…”
Get more information
Journal Article -
11
Omalizumab improves asthma-related quality of life in patients with severe allergic asthma
Published in Journal of allergy and clinical immunology (01-02-2003)“…Background: We have previously shown that omalizumab, a recombinant humanized monoclonal anti-IgE antibody, reduces asthma exacerbations and decreases inhaled…”
Get full text
Journal Article -
12
Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity and mortality
Published in Current medical research and opinion (01-01-2001)“…Add-on therapy with omalizumab, an anti-immunoglobulin E antibody, is effective in improving disease control in patients with allergic asthma of varying…”
Get full text
Journal Article -
13
Efficacy of omalizumab in allergic asthma patients at high-risk for asthma-related death
Published in Journal of allergy and clinical immunology (2002)Get full text
Journal Article -
14
Efficacy of Omalizumab, an Anti-immunoglobulin E Antibody, in Patients with Allergic Asthma at High Risk of Serious Asthma-related Morbidity and Mortality
Published in Current medical research and opinion (2001)“…SummaryAim: Add-on therapy with omalizumab, an anti-immunoglobulin E antibody, is effective in improving disease control in patients with allergic asthma of…”
Get full text
Journal Article