A5011780856- Cancer Immunotherapy and Biomarkers
- Pancreatic and Hepatic Oncology Research
- Colorectal Cancer Treatments and Studies
- Lung Cancer Treatments and Mutations
- Statistical Methods in Clinical Trials
- Chronic Lymphocytic Leukemia Research
- Optimal Experimental Design Methods
- Health Systems, Economic Evaluations, Quality of Life
- Statistical Methods and Bayesian Inference
- Asthma and respiratory diseases
- Advanced Statistical Methods and Models
- VLSI and FPGA Design Techniques
- Meta-analysis and systematic reviews
- Vaccine Coverage and Hesitancy
- Manufacturing Process and Optimization
- Cervical Cancer and HPV Research
- Musculoskeletal pain and rehabilitation
- Chronic Myeloid Leukemia Treatments
- Pain Management and Opioid Use
- Hepatitis B Virus Studies
- Structural Health Monitoring Techniques
- Statistical Methods and Inference
- Cancer Treatment and Pharmacology
- Monoclonal and Polyclonal Antibodies Research
- Cancer Genomics and Diagnostics
Incyte (United States)
2021-2023
Pfizer (United States)
1994-2019
Merck & Co., Inc., Rahway, NJ, USA (United States)
2007-2013
University of Debrecen
2012
The Geneva Association
2012
New York Proton Center
2012
World Health Organization - Pakistan
2012
Johns Hopkins University
2007
University of South Alabama
1985-1986
Southern Methodist University
1984
Despite the frequent use of pain recall ratings in clinical research, there remains doubt about ability individuals to accurately their pain. In particular, previous research indicates possibility that most experienced during a period and recent (known as peak end effects, respectively) might bias ratings. The current study used data from published trial determine relative validity 24-h rating average post-operative nature extent any biasing influence effects on nine separate results...
In vivo models have demonstrated that interleukin-13 (IL-13) plays an important role in asthma; however, few studies evaluated the effect of inhibition IL-13 on established and persistent disease. present study, we investigated a therapeutic dosing regimen with anti-IL-13 monoclonal antibody (mAb) chronic mouse model asthma. BALB/c mice were sensitized to allergen [ovalbumin (OVA); days 1 8] challenged OVA weekly from day 22. Anti-IL-13 mAb or vehicle was initiated following two challenges...
PF‐06647263, a novel antibody–drug conjugate consisting of an anti‐EFNA4 antibody linked to calicheamicin payload, has shown potent antitumor activity in human xenograft tumor models, including triple‐negative breast cancer (TNBC). In the dose‐escalation part 1 this multicenter, open‐label, phase I study (NCT02078752), successive cohorts patients ( n , 48) with advanced solid tumors and no available standard therapy received PF‐06647263 every 3 weeks (Q3W) or week (QW), following modified...
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...
Safety assessment is essential throughout medical product development. There has been increased awareness of the importance safety trials recently, in part due to recent US Food and Drug Administration guidance related thorough cardiovascular risk treatment type 2 diabetes. Bayesian methods provide great promise for improving conduct trials. In this paper, subteam Information Association Scientific Working Group evaluates challenges associated with current designing analyzing provides an...
Maximum likelihood estimation of parameters in linear structural relationships under normality assumptions requires knowledge one or more the model if no replication is available. The most common assumption added to definition that ratio error variances response and predictor variates known. use asymptotic formulae for mean squared errors as a function sample size assumed value variance investigated.
Abstract Purpose: This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ in combination with pembrolizumab [programmed death-1 (PD-1) inhibitor]. Experimental Design: Patients advanced metastatic solid tumors disease progression following all available therapies were enrolled received (Part initially 300 mg once daily) 10 daily; Part 2...
Linear structural models are linear relationships between two stochastic (random) variates in which both of the subject to measurement errors. Structural common experimental work, but typically fit using least squares. In this expository paper maximum likelihood estimators for presented and contrasted with corresponding squares estimators. Asymptotic variance formulae intercept slope given, along expressions functional models.
2511 Background: PF-06647263 is an anti-Ephrin-A4 (EFNA4) antibody drug conjugate (ADC) composed of a humanized mAb, hydrazone cleavable linker, and calicheamicin, potent DNA damaging agent. Higher levels EFNA4 expression have been shown in tumor versus normal tissue, including two thirds triple negative breast cancers (TNBC). In vivo preclinical studies demonstrate induced regression TNBC models. Methods: Part 1 dose escalation, cohorts 2-12 patient (pts) with solid tumors that were...
Maximum likelihood estimators for model parameters in linear structural relationships having correlated measurement errors are presented. Comparisons between asymptotic mean squared of least squares and maximum the slope parameter indicate that estimator is only preferable when sufficiently small relative to ratio error standard deviations; however, unlike independent errors, region preference not simply given by an upper bound on this scaled parameter.
<div>AbstractPurpose:<p>This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ in combination with pembrolizumab [programmed death-1 (PD-1) inhibitor].</p>Experimental Design:<p>Patients advanced metastatic solid tumors disease progression following all available therapies were enrolled received (Part initially...
<p>Tumor response by RECIST (full analysis set)</p>
9711 Background: IL-6, CRP and SAA are three biomarkers whose expressions have been shown to correlate with prognosis in select tumor models. We evaluated these their potential use as prognostic indicators renal cell carcinoma (RCC) prostate cancer a retrospective study. Methods: Serum samples from patients RCC or were obtained IMPATH-BCP, Inc. (New York, NY). Healthy control subjects also included. levels of measured using commercially available ELISA kits. Summary statistics calculated...
Suppose, in a clinical trial, the interest is to show that effectiveness of an experimental therapy no worse than standard by more specified amount, say delta units. Blackwelder (1) discussed this problem trials where outcome dichotomous. The group sequential procedures developed DeMets and Ware (2) are valid test Blackwelder's hypothesis for case = 0. In paper, asymmetric procedure modified handle > A two-stage considered drug interaction study focuses on specific side effect as event interest.
Evolution of Bayesian methods in real-life applications has come a long way. This is especially true regarding textbook material availability since the early days Jim Berger's classic book on Th...