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Clinical trial simulation

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https://www.readbyqxmd.com/read/28343164/a-quantitative-concordance-measure-for-comparing-and-combining-treatment-selection-markers
#1
Zhiwei Zhang, Shujie Ma, Lei Nie, Guoxing Soon
Motivated by an HIV example, we consider how to compare and combine treatment selection markers, which are essential to the notion of precision medicine. The current literature on precision medicine is focused on evaluating and optimizing treatment regimes, which can be obtained by dichotomizing treatment selection markers. In practice, treatment decisions are based not only on efficacy but also on safety, cost and individual preference, making it difficult to choose a single cutoff value for all patients in all settings...
March 25, 2017: International Journal of Biostatistics
https://www.readbyqxmd.com/read/28340333/the-randomized-crm-an-approach-to-overcoming-the-long-memory-property-of-the-crm
#2
Joseph S Koopmeiners, Andrew Wey
The primary object of a Phase I clinical trial is to determine the maximum tolerated dose (MTD). Typically, the MTD is identified using a dose-escalation study, where initial subjects are treated at the lowest dose level and subsequent subjects are treated at progressively higher dose levels until the MTD is identified. The continual reassessment method (CRM) is a popular model-based dose-escalation design, which utilizes a formal model for the relationship between dose and toxicity to guide dose finding. Recently, it was shown that the CRM has a tendency to get "stuck" on a dose level, with little escalation or de-escalation in the late stages of the trial, due to the long-memory property of the CRM...
March 1, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28339723/leveraging-molecular-datasets-for-biomarker-based-clinical-trial-design-in-glioblastoma
#3
Shyam K Tanguturi, Lorenzo Trippa, Shakti H Ramkissoon, Kristine Pelton, David Knoff, David Sandak, Neal I Lindeman, Azra H Ligon, Rameen Beroukhim, Giovanni Parmigiani, Patrick Y Wen, Keith L Ligon, Brian M Alexander
Background.: Biomarkers can improve clinical trial efficiency, but designing and interpreting biomarker-driven trials require knowledge of relationships among biomarkers, clinical covariates, and endpoints. We investigated these relationships across genomic subgroups of glioblastoma (GBM) within our institution (DF/BWCC), validated results in The Cancer Genome Atlas (TCGA), and demonstrated potential impacts on clinical trial design and interpretation. Methods.: We identified genotyped patients at DF/BWCC, and clinical associations across 4 common GBM genomic biomarker groups were compared along with overall survival (OS), progression-free survival (PFS), and survival post-progression (SPP)...
February 20, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/28335790/physical-mechanism-and-modeling-of-heat-generation-and-transfer-in-magnetic-fluid-hyperthermia-through-n%C3%A3-elian-and-brownian-relaxation-a-review
#4
REVIEW
Suriyanto, E Y K Ng, S D Kumar
Current clinically accepted technologies for cancer treatment still have limitations which lead to the exploration of new therapeutic methods. Since the past few decades, the hyperthermia treatment has attracted the attention of investigators owing to its strong biological rationales in applying hyperthermia as a cancer treatment modality. Advancement of nanotechnology offers a potential new heating method for hyperthermia by using nanoparticles which is termed as magnetic fluid hyperthermia (MFH). In MFH, superparamagnetic nanoparticles dissipate heat through Néelian and Brownian relaxation in the presence of an alternating magnetic field...
March 23, 2017: Biomedical Engineering Online
https://www.readbyqxmd.com/read/28328984/using-simulation-to-aid-trial-design-ring-vaccination-trials
#5
Matt David Thomas Hitchings, Rebecca Freeman Grais, Marc Lipsitch
BACKGROUND: The 2014-6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination. METHODS AND FINDINGS: We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days...
March 22, 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/28327195/does-rating-the-operation-videos-with-a-checklist-score-improve-the-effect-of-e-learning-for-bariatric-surgical-training-study-protocol-for-a-randomized-controlled-trial
#6
Javier Rodrigo De La Garza, Karl-Friedrich Kowalewski, Mirco Friedrich, Mona Wanda Schmidt, Thomas Bruckner, Hannes Götz Kenngott, Lars Fischer, Beat-Peter Müller-Stich, Felix Nickel
BACKGROUND: Laparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to operating on a patient. Multimodality training is vital for bariatric surgery. E-learning with videos is a standard approach for training. The present study investigates whether scoring the operation videos with performance checklists improves learning effects and transfer to a simulated operation...
March 21, 2017: Trials
https://www.readbyqxmd.com/read/28323871/power-considerations-for-the-application-of-detrended-fluctuation-analysis-in-gait-variability-studies
#7
Nikita A Kuznetsov, Christopher K Rhea
The assessment of gait variability using stochastic signal processing techniques such as detrended fluctuation analysis (DFA) has been shown to be a sensitive tool for evaluation of gait alterations due to aging and neuromuscular disease. However, previous studies have suggested that the application of DFA requires relatively long recordings (600 strides), which is difficult when working with clinical populations or older adults. In this paper we propose a model for predicting DFA variance in experimental data and conduct a Monte Carlo simulation to estimate the sample size and number of trials required to detect a change in DFA scaling exponent...
2017: PloS One
https://www.readbyqxmd.com/read/28323515/a-nested-group-sequential-framework-for-regional-evaluation-in-global-drug-development-program
#8
William Wang, Zhiwei Jiang, Jingjun Qiu, Jielai Xia, Xiang Guo
The primary objective of a multiregional clinical trial (MRCT) is to assess the efficacy of all participating regions and evaluate the probability of applying the overall results to a specific region. The consistency assessment of the target region with the overall results is the most common way of evaluating the efficacy in a specific region. Recently, Huang et al. (2012) proposed an additional trial in the target region to an MRCT to evaluate the efficacy in the target ethnic (TE) population under the framework of simultaneous global drug development program (SGDDP)...
February 10, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28322970/gold-nanoparticles-radiations-and-the-immune-system-current-insights-into-the-physical-mechanisms-and-the-biological-interactions-of-this-new-alliance-towards-cancer-therapy
#9
REVIEW
Nikolaos M Dimitriou, George Tsekenis, Evangelos C Balanikas, Athanasia Pavlopoulou, Melina Mitsiogianni, Theodora Mantso, George Pashos, Andreas G Boudouvis, Ioannis N Lykakis, Georgios Tsigaridas, Mihalis I Panayiotidis, Vassilios Yannopapas, Alexandros G Georgakilas
Considering both cancer's serious impact on public health and the side effects of cancer treatments, strategies towards targeted cancer therapy have lately gained considerable interest. Employment of gold nanoparticles (GNPs), in combination with ionizing and non-ionizing radiations, has been shown to improve the effect of radiation treatment significantly. GNPs, as high-Z particles, possess the ability to absorb ionizing radiation and enhance the deposited dose within the targeted tumors. Furthermore, they can convert non-ionizing radiation into heat, due to plasmon resonance, leading to hyperthermic damage to cancer cells...
March 16, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28322129/including-historical-data-in-the-analysis-of-clinical-trials-is-it-worth-the-effort
#10
Joost van Rosmalen, David Dejardin, Yvette van Norden, Bob Löwenberg, Emmanuel Lesaffre
Data of previous trials with a similar setting are often available in the analysis of clinical trials. Several Bayesian methods have been proposed for including historical data as prior information in the analysis of the current trial, such as the (modified) power prior, the (robust) meta-analytic-predictive prior, the commensurate prior and methods proposed by Pocock and Murray et al. We compared these methods and illustrated their use in a practical setting, including an assessment of the comparability of the current and the historical data...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28321893/dose-finding-methods-for-phase-i-clinical-trials-using-pharmacokinetics-in-small-populations
#11
Moreno Ursino, Sarah Zohar, Frederike Lentz, Corinne Alberti, Tim Friede, Nigel Stallard, Emmanuelle Comets
The aim of phase I clinical trials is to obtain reliable information on safety, tolerability, pharmacokinetics (PK), and mechanism of action of drugs with the objective of determining the maximum tolerated dose (MTD). In most phase I studies, dose-finding and PK analysis are done separately and no attempt is made to combine them during dose allocation. In cases such as rare diseases, paediatrics, and studies in a biomarker-defined subgroup of a defined population, the available population size will limit the number of possible clinical trials that can be conducted...
March 21, 2017: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/28321285/role-of-preliminary-registry-data-in-development-of-a-clinical-trial-for-an-innovative-device-a-small-but-integral-piece-of-a-health-policy-initiative
#12
Donald R Ricci, Joost de Vries, Raphael Blanc
Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28320462/varying-the-item-format-improved-the-range-of-measurement-in-patient-reported-outcome-measures-assessing-physical-function
#13
Gregor Liegl, Barbara Gandek, H Felix Fischer, Jakob B Bjorner, John E Ware, Matthias Rose, James F Fries, Sandra Nolte
BACKGROUND: Physical function (PF) is a core patient-reported outcome domain in clinical trials in rheumatic diseases. Frequently used PF measures have ceiling effects, leading to large sample size requirements and low sensitivity to change. In most of these instruments, the response category that indicates the highest PF level is the statement that one is able to perform a given physical activity without any limitations or difficulty. This study investigates whether using an item format with an extended response scale, allowing respondents to state that the performance of an activity is easy or very easy, increases the range of precise measurement of self-reported PF...
March 21, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28319254/a-bayesian-subgroup-analysis-using-collections-of-anova-models
#14
Jinzhong Liu, Siva Sivaganesan, Purushottam W Laud, Peter Müller
We develop a Bayesian approach to subgroup analysis using ANOVA models with multiple covariates, extending an earlier work. We assume a two-arm clinical trial with normally distributed response variable. We also assume that the covariates for subgroup finding are categorical and are a priori specified, and parsimonious easy-to-interpret subgroups are preferable. We represent the subgroups of interest by a collection of models and use a model selection approach to finding subgroups with heterogeneous effects...
March 20, 2017: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/28319031/evaluation-of-the-water-equivalence-of-plastic-materials-in-low-and-high-energy-clinical-proton-beams
#15
Ana Lourenco, David Shipley, Nigel Wellock, Russell Thomas, Hugo Bouchard, Andrzej Kacperek, Francesco Fracchiolla, Stefano Lorentini, Marco Schwarz, Niall MacDougall, Gary Royle, Hugo Palmans
The aim of this work was to evaluate the water-equivalence of new trial plastics designed specifically for light-ion beam dosimetry as well as commercially available plastics in clinical proton beams. The water-equivalence of materials was tested by computing a plastic-to-water conversion factor, <i>H</i><sub><i>pl</i>,w</sub>. Trial materials were characterized experimentally in 60 MeV and 226 MeV un-modulated proton beams and the results were compared with Monte Carlo simulations using the FLUKA code...
March 20, 2017: Physics in Medicine and Biology
https://www.readbyqxmd.com/read/28318420/bayesian-penalized-log-likelihood-ratio-approach-for-dose-response-clinical-trial-studies
#16
Yuanyuan Tang, Chunyan Cai, Liangrui Sun, Jianghua He
In literature, there are a few unified approaches to test proof of concept and estimate a target dose, including the multiple comparison procedure using modeling approach, and the permutation approach proposed by Klingenberg. We discuss and compare the operating characteristics of these unified approaches and further develop an alternative approach in a Bayesian framework based on the posterior distribution of a penalized log-likelihood ratio test statistic. Our Bayesian approach is much more flexible to handle linear or nonlinear dose-response relationships and is more efficient than the permutation approach...
February 13, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28318251/molecular-simulation-studies-on-the-binding-selectivity-of-type-i-inhibitors-in-the-complexes-with-ros1-versus-alk
#17
Yuanxin Tian, Yonghuan Yu, Yudong Shen, Hua Wan, Shan Chang, Tingting Zhang, Shanhe Wan, Jiajie Zhang
ROS1 and ALK are promising targets of anti-cancer drugs for non small cell lung cancer. Since they have 49% amide acid sequence homology in the kinases domain and 77% identity at the ATP binding area, some ALK inhibitors also showed some significant responses for ROS1 in the clinical trial, such as the type-I binding inhibitor crizotinib and PF-06463922. As a newly therapeutic target, selective ROS1 inhibitor is relative rarely. Moreover, the molecular basis for the selectivity of ROS1 versus ALK still remains unclear...
March 20, 2017: Journal of Chemical Information and Modeling
https://www.readbyqxmd.com/read/28304309/mouse-models-of-alzheimer-s-disease
#18
Gisela Esquerda-Canals, Laia Montoliu-Gaya, Jofre Güell-Bosch, Sandra Villegas
Alzheimer's disease (AD) is a neurodegenerative disorder that nowadays affects more than 40 million people worldwide and it is predicted to exponentially increase in the coming decades. Because no curative treatment exists, research on the pathophysiology of the disease, as well as the testing of new drugs, are mandatory. For these purposes, animal models constitute a valuable, although perfectible tool. This review takes a tour through several aspects of mouse models of AD, such as the generation of transgenic models, the relevance of the promoter driving the expression of the transgenes, and the concrete transgenes used to simulate AD pathophysiology...
March 10, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28304215/use-of-statistical-and-pharmacokinetic-pharmacodynamic-modeling-and-simulation-to-improve-decision-making-a-section-summary-report-of-the-trends-and-innovations-in-clinical-trial-statistics-conference
#19
Holly Kimko, Seth Berry, Michael O'Kelly, Nitin Mehrotra, Matthew Hutmacher, Venkat Sethuraman
The application of modeling and simulation (M&S) methods to improve decision-making was discussed during the Trends & Innovations in Clinical Trial Statistics Conference held in Durham, North Carolina, USA on May 1-4, 2016. Uses of both pharmacometric and statistical M&S were presented during the conference, highlighting the diversity of the methods employed by pharmacometricians and statisticians to address a broad range of quantitative issues in drug development. Five presentations are summarized herein, which cover the development strategy of employing M&S to drive decision-making; European initiatives on best practice in M&S; case studies of pharmacokinetic/pharmacodynamics modeling in regulatory decisions; estimation of exposure-response relationships in the presence of confounding; and the utility of estimating the probability of a correct decision for dose selection when prior information is limited...
February 7, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28299963/cost-effectiveness-analysis-on-the-use-of-fidaxomicin-and-vancomycin-to-treat-clostridium-difficile-infection-in-france
#20
Maureen Watt, Aurélien Dinh, Alban Le Monnier, Patrick Tilleul
BACKGROUND: Fidaxomicin is a macrocyclic antibiotic with proven efficacy against Clostridium difficile infection (CDI) in adults. It was licensed in France in 2012, but, due to higher acquisition costs compared with existing treatments, healthcare providers require information on its cost/benefit profile. OBJECTIVE: To compare healthcare costs and health outcomes of fidaxomicin and vancomycin, as reference treatment for CDI. METHODS: A Markov model was used to simulate the treatment pathway, over 1 year, of adult patients with CDI receiving fidaxomicin or vancomycin...
March 16, 2017: Journal of Medical Economics
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