A5040522070- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Viral gastroenteritis research and epidemiology
- Optimal Experimental Design Methods
- Animal Virus Infections Studies
- Statistical Methods and Bayesian Inference
- Pharmaceutical Economics and Policy
- Viral Infections and Immunology Research
- Statistical Methods and Inference
- Lipoproteins and Cardiovascular Health
- Computational Drug Discovery Methods
- Meta-analysis and systematic reviews
- Vaccine Coverage and Hesitancy
- Healthcare Policy and Management
- Molecular Biology Techniques and Applications
- Pharmaceutical studies and practices
- RNA Interference and Gene Delivery
- SARS-CoV-2 and COVID-19 Research
- Advanced Causal Inference Techniques
- Herpesvirus Infections and Treatments
- Diabetes, Cardiovascular Risks, and Lipoproteins
- Biosimilars and Bioanalytical Methods
- Advanced Statistical Process Monitoring
- Monoclonal and Polyclonal Antibodies Research
- Pharmacovigilance and Adverse Drug Reactions
Merck & Co., Inc., Rahway, NJ, USA (United States)
2004-2020
Decision Sciences (United States)
2010-2019
United States Military Academy
2004-2014
Temple University
1985-2008
Merck (France)
2006
Kaiser Permanente
2002
Institut de Recherche Vaccinale
1999
National Institutes of Health
1995-1998
Atrium Health Wake Forest Baptist
1995-1998
Wake Forest University
1995-1998
Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned receive three oral doses live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, P[8] or placebo at 4-to-10-week intervals in blinded fashion. Active surveillance was used identify subjects with serious adverse other events.The 34,035 the group 34,003 monitored for...
Experiments in which the treatments are composed of a series doses compound and zero dose control often used animal toxicity studies. A test procedure is proposed to assess trends response variable. The notion no-statistical-significance-of-trend (NOSTASOT) introduced, questions multiplicity statistical tests this context addressed.
Abstract Finasteride is a specific 5‐α‐reductase inhibitor that has been shown to reduce prostate size and decrease serum levels of antigen (PSA). Among men who received finasteride (5 mg/day) for 12 months in North American clinical trials whom cancer was not diagnosed the median percentage change PSA −50% (5–95% range: −81% + 20%). At baseline 72% had ⩽ 4.0 ng/ml 93% 10.0 ng/ml. After on finasteride, 75% 2.0 95% 5.0 Thus, proportion BPH patients with after treatment comparable pretreatment...
Clinical adverse experience (AE) data are routinely evaluated using between group P values for every AE encountered within each of several body systems. If the reported and interpreted without multiplicity considerations, there is a potential an excess false positive findings. Procedures based on confidence interval estimates treatment effects have same findings as value methods. Excess can needlessly complicate safety profile safe drug or vaccine. Accordingly, we propose novel method...
We used the large clinical database that supported development of Oka/ Merck varicella vaccine to study relationship between primary antibody response, as determined by gpELISA, an enzyme-linked immunosorbent assay detects antibodies varicella-zoster virus (VZV) glycoprotein, and subsequent risk postvaccination breakthrough varicella.We vaccinated 1,164 healthy children with a single dose containing 2900 9000 plaque-forming units/dose. The immune response vaccination was gpELISA 6 weeks...
RNA interference (RNAi) high-throughput screening (HTS) has been hailed as the 2nd genomics wave following 1st of gene expression microarrays and single-nucleotide polymorphism discovery platforms.Following an RNAi HTS, authors are interested in identifying short interfering (siRNA) hits with large inhibition/activation effects.For hit selection, z-score method its variants commonly used primary HTS experiments.Recently, strictly standardized mean difference (SSMD) proposed to measure siRNA...
Because of the potential for large variability among countries in utilization and cost health care resources, it is important to assess appropriateness combining economic data across a multinational clinical trial. We show how available tests interaction can be applied endpoints, including cost-effectiveness ratios net benefits. This analysis includes characterization possible interactions being quantitative or qualitative nature. In absence interaction, pooled estimate endpoint should...
Background. Administration of M-M-R II (Measles, Mumps and Rubella Virus Vaccine, Live) VARIVAX [Varicella Vaccine Live (Oka/Merck)] given concomitantly at separate injection sites during the same office visit could increase vaccine compliance by reducing number health care visits for immunizations. We compared safety immunogenicity (Group A) with administration two vaccines 6 weeks apart B) as well persistence varicella antibody duration protection afforded vaccine. Methods. A total 603...
Kernel densities provide accurate non-parametric estimates of the overlapping coefficient or proportion similar responses (PSR) in two populations. Non-parametric avoid strong assumptions on shape populations, such as normality equal variance, and possess sampling variation approaching that parametric estimates. We obtain standard error by bootstrap resampling. illustrate practical use these methods examples simulations to explore properties estimators under various situations.
In many clinical trials and evaluations using medical care administrative databases it is of interest to estimate not only the survival time a given treatment modality but also total associated cost. The most widely used estimator for data subject censoring Kaplan-Meier (KM) or product-limit (PL) estimator. optimality properties this applied time-to-event (consistency, etc.) under assumptions random censorship have been established. However, whenever relationship between cost includes an...
Abstract In vaccine clinical trials, humoral antibody responses are often used to measure the effect of a because they correlate with vaccine's protective efficacy against target disease. While concept protection usually refers establishing level titre, identifying clear‐cut value is impossible not related solely titre. We propose examining relationship between disease and whole distribution rather than single cut‐off level. particular, we use failure‐time models estimate long‐term...
Abstract We describe and illustrate the use of a generalizable model for evaluating cost-effectiveness alternative cholesterol-lowering treatments. combine standard incidence-based techniques measuring cost illness with logistic risk functions from Framingham Heart Study to project, persons known coronary characteristics, likelihood developing heart disease (CHD) over lifetime as well number related outcomes, including expected loss years life due CHD, direct indirect costs changes in these...
Abstract The evaluation of vaccine safety involves pre‐clinical animal studies, pre‐licensure randomized clinical trials, and post‐licensure studies. Sequential design analysis are particular interest because they allow early termination the trial or quick detection that exceeds a prescribed bound on adverse event rate. After review recent developments in this area, we propose new class sequential generalized likelihood ratio tests for evaluating rates two‐armed trials single‐armed proposed...
A new efficacy measure is developed for use in prevention trials of interventions which may affect both disease incidence and severity. We assign a severity score to each incident case sum scores over all cases within treatment group create burden-of-illness group. Efficacy evaluated by the difference between per randomized subject two groups. Since numbers summands random variable, standard methods analysis are not directly applicable. The asymptotic distribution sampling properties net...
Abstract Because the evaluation of rodent carcinogenicity studies involves performing a statistical analysis at each tumor site encountered it is important to understand extent which this multiplicity affects false positive rate. It equally apply methods accounting for in analysis. In paper we discuss one such method calculating overall significance level associated with P 1 , most extreme isolated trend ‐value observed among sites encountered. The constructs distribution scores...
RNA interference (RNAi) not only plays an important role in drug discovery but can also be developed directly into drugs. RNAi high-throughput screening (HTS) biotechnology allows us to conduct genome-wide research. A central challenge research is integrate both experimental and computational approaches obtain high quality HTS assays. Based on our daily practice experiments, we propose the implementation of 3 analytic processes improve data from biotechnology: (1) select effective biological...
Developing sophisticated statistical methods for go/no-go decisions is crucial clinical trials, as planning phase III or IV trials costly and time consuming. In this paper, we develop a novel Bayesian methodology determining the probability of success treatment regimen on basis current data given trial. We introduce new criterion calculating that allows inclusion covariates well allowing historical based regimen, patient characteristics. A class prior distributions covariate developed to...