Search Results - "Frank Liu, G."
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Dynamic RMST curves for survival analysis in clinical trials
Published in BMC medical research methodology (27-08-2020)“…The data from immuno-oncology (IO) therapy trials often show delayed effects, cure rate, crossing hazards, or some mixture of these phenomena. Thus, the…”
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2
Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine
Published in Human vaccines & immunotherapeutics (03-10-2017)“…Although clinical trials of the pentavalent rotavirus vaccine (RotaTeq®, RV5) have demonstrated efficacy against RV gastroenteritis (RGE) in low and…”
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3
Comparisons of Methods for Analysis of Repeated Binary Responses with Missing Data
Published in Journal of biopharmaceutical statistics (01-05-2011)“…It is important yet challenging to choose an appropriate analysis method for the analysis of repeated binary responses with missing data. The conventional…”
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4
A dynamic power prior for borrowing historical data in noninferiority trials with binary endpoint
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01-01-2018)“…Summary Traditionally, noninferiority hypotheses have been tested using a frequentist method with a fixed margin. Given that information for the control group…”
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5
On analysis of longitudinal clinical trials with missing data using reference-based imputation
Published in Journal of biopharmaceutical statistics (02-09-2016)“…Reference-based imputation (RBI) methods have been proposed as sensitivity analyses for longitudinal clinical trials with missing data. The RBI methods…”
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6
Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries
Published in The Pediatric infectious disease journal (01-01-2017)“…BACKGROUND:Rotavirus is the leading cause of severe diarrhea worldwide in young children. Although rotavirus vaccine efficacy is high in developed countries,…”
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Integrated Safety Profile of a New Approved, Fully Liquid DTaP5-HB-IPV-Hib Vaccine
Published in The Pediatric infectious disease journal (01-04-2019)“…DTaP5-HB-IPV-Hib is a fully liquid, hexavalent vaccine containing a 5-antigen pertussis component, approved since 2016 in Europe [Vaxelis; DTaP5-HB-IPV-Hib…”
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Integrated Safety Profile of a New Approved, Fully Liquid DTaP5-HB-IPV-Hib Vaccine
Published in The Pediatric infectious disease journal (01-04-2019)“…BACKGROUND:DTaP5-HB-IPV-Hib is a fully liquid, hexavalent vaccine containing a 5-antigen pertussis component, approved since 2016 in Europe [Vaxelis;…”
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A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11–12 months
Published in Vaccine (19-07-2016)“…Abstract Background Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-HB-IPV-Hib is a new investigational,…”
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A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months
Published in The Pediatric infectious disease journal (01-02-2017)“…BACKGROUND:Combination vaccines simplify vaccination visits and improve coverage and timeliness. Diphtheria–tetanus toxoids–acellular pertussis 5, hepatitis B,…”
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Evaluation of program success for programs with multiple trials in binary outcomes
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01-05-2015)“…A late‐stage clinical development program typically contains multiple trials. Conventionally, the program's success or failure may not be known until the…”
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12
Evaluating the adaptive performance of flexible sample size designs with treatment difference in an interval
Published in Statistics in medicine (20-02-2008)“…In clinical trials, the study sample size is often chosen to provide specific power at a single point of a treatment difference. When this treatment difference…”
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13
Confidence intervals for an exposure adjusted incidence rate difference with applications to clinical trials
Published in Statistics in medicine (30-04-2006)“…To summarize safety data such as clinical adverse experiences in clinical trials with a moderate to long‐term follow‐up, we may use a measurement which…”
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Testing for Crossover of Two Hazard Functions Using Gail and Simon's Method
Published in Journal of biopharmaceutical statistics (01-05-2006)“…Crossover of two hazard functions is sometimes called qualitative nonproportionality where the hazard ratio could be >1 in some time intervals but <1 in some…”
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A Note on the Estimate of Treatment Effect from a Cox Regression Model When the Proportionality Assumption Is Violated
Published in Communications in statistics. Theory and methods (01-04-2006)“…Cox proportional hazards regression model has been widely used to estimate the effect of a prognostic factor on a time-to-event outcome. In a survey of…”
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For the Special Issue on Statistical Methods for Clinical Trials and Precision Medicine
Published in Statistics in biosciences (01-08-2018)Get full text
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Noninferiority Testing in Clinical Trials: Issues and Challenges
Published in The American Statistician (01-11-2015)Get full text
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