A5103018650- Statistical Methods in Clinical Trials
- Optimal Experimental Design Methods
- Health Systems, Economic Evaluations, Quality of Life
- Statistical Methods and Bayesian Inference
- Meta-analysis and systematic reviews
- Advanced Statistical Process Monitoring
- Statistical Methods and Inference
- Statistical Distribution Estimation and Applications
- Healthcare Policy and Management
- Advanced Statistical Methods and Models
- Forecasting Techniques and Applications
- Advanced Causal Inference Techniques
- Pharmacogenetics and Drug Metabolism
- Livestock Management and Performance Improvement
- Human-Animal Interaction Studies
- Wildlife Ecology and Conservation
- Pharmaceutical studies and practices
- Fault Detection and Control Systems
- Pesticide Residue Analysis and Safety
- Nursing Roles and Practices
- Formal Methods in Verification
- Freezing and Crystallization Processes
- Pancreatic and Hepatic Oncology Research
- DNA and Biological Computing
- Advanced Control Systems Optimization
Statistical Research (United States)
2022-2024
Can-Fite BioPharma (Israel)
2021
Purdue Pharma (Canada)
2001-2005
Purdue Pharma (United States)
2004
Sanofi (United States)
1999
Janssen (United States)
1990-1992
Novartis (Switzerland)
1988-1990
University at Buffalo, State University of New York
1985-1990
Namodenoson, an A3 adenosine-receptor agonist, showed promising results in advanced hepatocellular carcinoma (HCC) and moderate hepatic dysfunction (Child–Pugh B; CPB) a phase I/II clinical study. This II study investigated namodenoson as second-line therapy such patients. Patients were randomized 2:1 to twice day (BID) (25 mg; n = 50) or placebo (n 28). The primary endpoint (overall survival [OS]) was not met. Median OS 4.1/4.3 months for namodenoson/placebo (hazard ratio [HR], 0.82; 95%...
Abstract Although estimation and confidence intervals have become popular alternatives to hypothesis testing p ‐values, statisticians usually determine sample sizes for randomized clinical trials by controlling the power of a statistical test at an appropriate alternative, even those who recommend use inference. There is merit in achieving consistency techniques data analysis size determination. To that end, this paper compares determination with length interval obtained control power.
The two one-sided tests procedure of Schuirmann (1987) has become the standard technique for assessing bioequivalence formulations same drug. power this is examined to determine sample size required control power. A simple approximation presented.
Interim analyses are often employed to terminate comparative clinical trials for ethical or economic reasons when the evidence indicates that one treatment is superior other. Here an interim analysis proposed situation where a one-sided test be performed. The consists of trial if it appears null hypothesis interest true. By noting incorporation single similar two-stage procedure used constructing with power independent unknown variance, also includes estimation which can control not...
The analysis of data from clinical trials often includes subgroup analyses, which are performed to examine the treatment effect within various sets patients based on baseline and/or demographic variables. goals these analyses establish consistency results across subgroups and identify important prognostic factors. p-values for such usually presented without any adjustment multiple analyses: This approach has been criticized because possibility misleading false positives. Conservative...
The problem of establishing the equivalence an experimental treatment to a control with respect binary (“success” or “failure”) response variable may be solved using approximate (1 -α) 100% confidence interval for difference in rates (i.e., success probabilities). If goal is show that not sufficiently worse than control, then decision rule based on magnitude one limit can used. A procedure suggested by Food and Drug Administration allows value which compared depend data. consequences...
Comparative clinical trials are usually conducted to compare the means associated with treatments. However, it is often also of interest variances. Here problem testing equality variances two treatments in a two-by-two crossover design examined.
An asymptotically distribution–free confidence interval for the difference of p –th quantiles two distributions was presented by ALBERS and LOHNBERG (1984). A modification their procedure is use when sample sizes are specified.
For clinical trials that entail observations at successive visits for the occurrence of a side effect, this paper considers likelihood-based method to compare effect incidence rates. The method, which employs assumption Markov chain order one vectors binary responses, handles missing data due premature withdrawals. An actual numerical example and simulated illustrate technique.
Noninferiority of a new treatment to reference with respect efficacy is usually associated the superiority other aspects not efficacy. When specified safety variable, it may be necessary perform between-treatment comparisons. The and comparisons considered separately or simultaneous performed. Here techniques are discussed for consideration both aspects.
Abstract The variable ‘walking time to moderate angina’ on an exercise stress test is the primary means judge efficacy of new treatments for angina pectoris. Unfortunately, angina’; often censored by fatigue or other reasons premature termination test. If not treatment‐dependent, we propose use survival analysis techniques in such trials. We present example from a placebo‐controlled multicentre clinical trial and results simulations that compare various methods analysis.
A survey of the United States and Canadian governmental agencies investigated environmental impact relative invasiveness free-roaming domestic non-native carnivores-dogs, cats, ferrets. Agencies represented wildlife, fish, game, natural or resources, parks recreation, veterinary human health, animal control, agriculture. Respondents were asked to document number frequency sightings unconfined animals, evidence for harm, resulting "degree concern" in their respective jurisdictions. Results...
Abstract OBJECTIVE To assess the temperature stability of an autodefrost freezer commonly used in veterinary practices, whether use a Styrofoam cooler within provides stability, and ease remote monitoring system for notification elevations. ANIMALS None. METHODS Temperature 2 coolers were assessed with thermometers every 15 minutes. values monitored from October 11 to December 18, 2023 (for 68-day period). Data analysis focused on temperatures exceeding 0 °C elevations relative freezer....
Abstract The problem of comparing two treatments with respect to a continuous response variable, following an exponential distribution, is considered. It assumed that relevant comparative clinical trial planned either (i) test the effect one treatment larger or not much smaller than other, (ii) whether are equivalent, (iii) select better when they may be equivalent and otherwise assert equivalence. Statistical procedures for achieving these goals proposed description required sample sizes...
Abstract We consider a fixed‐sample parallel‐group clinical trial with an interim analysis that tests H o : μ x = y against 1 < . If we do not reject at the analysis, then probability of making type I error by rejecting in favour 2 > and power final are appreciably affected performing for certain relevant critical regions.