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Clinical trial simulation

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https://www.readbyqxmd.com/read/27922719/markov-mixed-effects-modeling-using-electronic-adherence-monitoring-records-identifies-influential-covariates-to-hiv-preexposure-prophylaxis
#1
Kumpal Madrasi, Ayyappa Chaturvedula, Jessica E Haberer, Mark Sale, Michael J Fossler, David Bangsberg, Jared M Baeten, Connie Celum, Craig W Hendrix
Adherence is a major factor in the effectiveness of preexposure prophylaxis (PrEP) for HIV prevention. Modeling patterns of adherence helps to identify influential covariates of different types of adherence as well as to enable clinical trial simulation so that appropriate interventions can be developed. We developed a Markov mixed-effects model to understand the covariates influencing adherence patterns to daily oral PrEP. Electronic adherence records (date and time of medication bottle cap opening) from the Partners PrEP ancillary adherence study with a total of 1147 subjects were used...
December 6, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27922569/mode-of-information-delivery-does-not-effect-anesthesia-trainee-performance-during-simulated-perioperative-pediatric-critical-events-a-trial-of-paper-versus-electronic-cognitive-aids
#2
Scott C Watkins, Shilo Anders, Anna Clebone, Elisabeth Hughes, Vikram Patel, Laura Zeigler, Yaping Shi, Matthew S Shotwell, Matthew D McEvoy, Matthew B Weinger
INTRODUCTION: Cognitive aids (CAs), including emergency manuals and checklists, have been recommended as a means to address the failure of healthcare providers to adhere to evidence-based standards of treatment during crisis situations. Unfortunately, users of CAs still commit errors, omit critical steps, fail to achieve perfect adherence to guidelines, and frequently choose to not use CA during both simulated and real crisis events. We sought to evaluate whether the mode in which a CA presents information (ie, paper vs...
December 2016: Simulation in Healthcare: Journal of the Society for Simulation in Healthcare
https://www.readbyqxmd.com/read/27920364/an-optimal-wilcoxon-mann-whitney-test-of-mortality-and-a-continuous-outcome
#3
Roland A Matsouaka, Aneesh B Singhal, Rebecca A Betensky
We consider a two-group randomized clinical trial, where mortality affects the assessment of a follow-up continuous outcome. Using the worst-rank composite endpoint, we develop a weighted Wilcoxon-Mann-Whitney test statistic to analyze the data. We determine the optimal weights for the Wilcoxon-Mann-Whitney test statistic that maximize its power. We derive a formula for its power and demonstrate its accuracy in simulations. Finally, we apply the method to data from an acute ischemic stroke clinical trial of normobaric oxygen therapy...
December 5, 2016: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/27919393/business-analysis-for-a-sustainable-multi-stakeholder-ecosystem-for-leveraging-the-electronic-health-records-for-clinical-research-ehr4cr-platform-in-europe
#4
Danielle Dupont, Ariel Beresniak, Mats Sundgren, Andreas Schmidt, John Ainsworth, Pascal Coorevits, Dipak Kalra, Marc Dewispelaere, Georges De Moor
INTRODUCTION: The Electronic Health Records for Clinical Research (EHR4CR) technological platform has been developed to enable the trustworthy reuse of hospital electronic health records data for clinical research. The EHR4CR platform can enhance and speed up clinical research scenarios: protocol feasibility assessment, patient identification for recruitment in clinical trials, and clinical data exchange, including for reporting serious adverse events. Our objective was to seed a multi-stakeholder ecosystem to enable the scalable exploitation of the EHR4CR platform in Europe, and to assess its economic sustainability...
January 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/27919355/model-observational-bridging-study-on-the-effectiveness-of-ezetimibe-on-cardiovascular-morbidity-and-mortality-in-france-a-population-based-study
#5
Jean Ferrières, Jean Dallongeville, Michel Rossignol, Jacques Bénichou, J Jaime Caro, Denis Getsios, Luis Hernandez, Lucien Abenhaim, Lamiae Grimaldi-Bensouda
BACKGROUND: To evaluate the real-life impact of ezetimibe on cardiovascular (CV) morbidity and mortality in France. OBJECTIVE: To estimate the number of non-fatal and fatal CV events that could be prevented and corresponding number of patients needed to treat (NNT) with ezetimibe to prevent one CV event over 5 years. METHODS: Non-interventional 48-month follow-up cohort conducted in hypercholesterolemic patients starting on ezetimibe <3 months at study entry, either as monotherapy or combined with statins...
November 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27918612/generalized-semiparametric-varying-coefficient-model-for-longitudinal-data-with-applications-to-adaptive-treatment-randomizations
#6
Li Qi, Yanqing Sun, Peter B Gilbert
This article investigates a generalized semiparametric varying-coefficient model for longitudinal data that can flexibly model three types of covariate effects: time-constant effects, time-varying effects, and covariate-varying effects. Different link functions can be selected to provide a rich family of models for longitudinal data. The model assumes that the time-varying effects are unspecified functions of time and the covariate-varying effects are parametric functions of an exposure variable specified up to a finite number of unknown parameters...
December 5, 2016: Biometrics
https://www.readbyqxmd.com/read/27917685/phosphodiesterase-10-inhibitors-in-clinical-development-for-cns-disorders
#7
Hugo Geerts, Athan Spiros, Patrick Roberts
Phosphodiesterase 10 inhibitors (PDE10-I), are conceptually attractive drugs with a potential great therapeutic window as their enriched striatal localization may likely stimulate D1R and reduce D2R downstream effects. However, so far selective PDE10-I with efficacy in animal models have not shown benefit in clinical trials and unexpectedly revealed a substantial dyskinesia motor side-effect. Areas covered: This paper reviews the underlying biological rationale of PDE10 as a target in schizophrenia, Parkinson's and Huntington's disease based on peer-reviewed published articles, the status of the different PDE10-I in clinical development for various CNS indications and explores possible reasons for the clinical trial failures and translational disconnect...
December 3, 2016: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/27917367/the-role-of-interaction-model-in-simulation-of-drug-interactions-and-qt-prolongation
#8
REVIEW
Barbara Wiśniowska, Sebastian Polak
Computational modelling is a cornerstone of Comprehensive In Vitro Proarrhythmia Assay and is re-increasingly being used in drug development. Electrophysiological effects of drug-drug interactions can be predicted in silico, e.g. with the use of in vitro cardiac ion channel data, PK profiles and human ventricular cardiomyocyte models. There are, however, several approaches with different assumptions used to assess the combined effect of multiple drugs, and there is no agreed standard interaction model. The aim of this study was to assess whether the choice of the drug-drug interaction (DDI) model (Bliss independence, Loewe additivity, or simple sum) influences the results of QT interval simulation trial...
2016: Current Pharmacology Reports
https://www.readbyqxmd.com/read/27913989/cost-effectiveness-analysis-of-isavuconazole-vs-voriconazole-as-first-line-treatment-for-invasive-aspergillosis
#9
Rachel Harrington, Edward Lee, Hongbo Yang, Jin Wei, Andrew Messali, Nkechi Azie, Eric Q Wu, James Spalding
INTRODUCTION: Invasive aspergillosis (IA) is associated with a significant clinical and economic burden. The phase III SECURE trial demonstrated non-inferiority in clinical efficacy between isavuconazole and voriconazole. No studies have evaluated the cost-effectiveness of isavuconazole compared to voriconazole. The objective of this study was to evaluate the costs and cost-effectiveness of isavuconazole vs. voriconazole for the first-line treatment of IA from the US hospital perspective...
December 2, 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27910826/enhancing-radiotherapy-for-lung-cancer-using-immunoadjuvants-delivered-in-situ-from-new-design-radiotherapy-biomaterials-a-preclinical-study
#10
Yao Hao, Sayeda Yasmin-Karim, Michele Moreau, Neeharika Sinha, Erno Sajo, Wilfred Ngwa
Studies show that radiotherapy of a primary tumor in combination with immunoadjuvants (IA) can result in increased survival or immune-mediated regression of metastasis outside the radiation field, a phenomenon known as abscopal effect. However, toxicities due to repeated systematic administration of IA have been shown to be a major obstacle in clinical trials. To minimize the toxicities and prime a more potent immune response, Ngwa et al have proposed that inert radiotherapy biomaterials such as fiducials could be upgraded to multifunctional ones loaded with IA for in situ delivery directly into the tumor sub-volume at no additional inconvenience to patients...
December 21, 2016: Physics in Medicine and Biology
https://www.readbyqxmd.com/read/27910730/retrospective-use-of-pbpk-modelling-to-understand-a-clinical-drug-drug-interaction-between-dextromethorphan-and-gsk1034702
#11
Michael J Hobbs, Jackie Bloomer, Gordon Dear
: 1. PURPOSE: In a clinical trial, a strong drug-drug interaction (DDI) was observed between dextromethorphan (DM, the object or victim drug) and GSK1034702 (the precipitant or perpetrator drug), following single and repeat doses. This study determined the inhibition parameters of GSK1034702 in vitro and applied PBPK modelling approaches to simulate the clinical observations and provide mechanistic hypotheses to understand the DDI. 2. METHODS: In vitro assays were conducted to determine the inhibition parameters of human CYP2D6 by GSK1034702...
December 2, 2016: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/27910116/the-cost-effectiveness-of-testing-for-ns5a-resistance-associated-polymorphisms-at-baseline-in-genotype-1a-infected-treatment-na%C3%A3-ve-and-treatment-experienced-subjects-treated-with-all-oral-elbasvir-grazoprevir-regimens-in-the-united-states
#12
E H Elbasha, M N Robertson, C Nwankwo
BACKGROUND: The presence of baseline NS5A resistance-associated variants (RAVs) impacted treatment response in HCV genotype 1a (GT1a)-infected patients treated with elbasvir/grazoprevir (EBR/GZR) for 12 weeks, but not patients treated with EBR/GZR and ribavirin (RBV) for 16 weeks. AIM: We assessed the cost-effectiveness of baseline testing for NS5A RAVs in EBR/GZR-treated patients compared without testing and with current treatments for GT1a patients. METHODS: We simulated the course of treatment with EBR/GZR, ledipasvir/sofosbuvir (LDV/SOF) and ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) with or without RBV and natural history of disease of GT1a patients...
December 1, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27909650/pbpk-modeling-and-simulation-in-drug-research-and-development
#13
REVIEW
Xiaomei Zhuang, Chuang Lu
Physiologically based pharmacokinetic (PBPK) modeling and simulation can be used to predict the pharmacokinetic behavior of drugs in humans using preclinical data. It can also explore the effects of various physiologic parameters such as age, ethnicity, or disease status on human pharmacokinetics, as well as guide dose and dose regiment selection and aid drug-drug interaction risk assessment. PBPK modeling has developed rapidly in the last decade within both the field of academia and the pharmaceutical industry, and has become an integral tool in drug discovery and development...
September 2016: Acta Pharmaceutica Sinica. B
https://www.readbyqxmd.com/read/27906472/long-term-clinical-impact-and-cost-effectiveness-of-obeticholic-acid-for-the-treatment-of-primary-biliary-cholangitis
#14
Sumeyye Samur, Matthew Klebanoff, Reiner Banken, Daniel S Pratt, Rick Chapman, Daniel A Ollendorf, Anne M Loos, Kathleen Corey, Chin Hur, Jagpreet Chhatwal
: Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune liver disease that mainly affects middle-aged women. Obeticholic acid (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demonstrated positive effects on biochemical markers of liver function. Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA...
November 7, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27900953/feedback-control-policies-employed-by-people-using-intracortical-brain-computer-interfaces
#15
Francis R Willett, Chethan Pandarinath, Beata Jarosiewicz, Brian A Murphy, William D Memberg, Christine H Blabe, Jad Saab, Benjamin L Walter, Jennifer A Sweet, Jonathan P Miller, Jaimie M Henderson, Krishna V Shenoy, John D Simeral, Leigh R Hochberg, Robert F Kirsch, A Bolu Ajiboye
OBJECTIVE: When using an intracortical BCI (iBCI), users modulate their neural population activity to move an effector towards a target, stop accurately, and correct for movement errors. We call the rules that govern this modulation a 'feedback control policy'. A better understanding of these policies may inform the design of higher-performing neural decoders. APPROACH: We studied how three participants in the BrainGate2 pilot clinical trial used an iBCI to control a cursor in a 2D target acquisition task...
November 30, 2016: Journal of Neural Engineering
https://www.readbyqxmd.com/read/27898627/publishing-trends-in-the-field-of-pediatric-emergency-medicine-from-2004-to-2013
#16
Nancy S Rixe, Jeffrey Rixe, Joshua Glick, Erik Lehman, Robert P Olympia
OBJECTIVE: To identify publishing trends within the field of pediatric emergency medicine between 2004 and 2013. METHODS: We conducted a MEDLINE search of pediatric emergency medicine articles, filtered by clinical trial, published between 2004 and 2013 in ten journals from the fields of pediatrics, emergency medicine, general medicine, and pediatric emergency medicine. Each article was classified by journal type, study design, results (positive or negative/equivocal), age/type of subjects, and major topic (based on the objective of the study)...
December 2016: Pediatric Emergency Care
https://www.readbyqxmd.com/read/27898429/dosimetric-improvements-with-a-novel-breast-stereotactic-radiotherapy-device-for-delivery-of-preoperative-partial-breast-irradiation
#17
James W Snider Iii, Yildirim Mutaf, Elizabeth Nichols, Andrea Hall, Patrick Vadnais, William F Regine, Steven J Feigenberg
OBJECTIVE: Partial-breast irradiation (PBI) with external-beam radiotherapy has produced higher than expected rates of fair-to-poor cosmesis. Worsened outcomes have been correlated with larger volumes of breast tissue exposed to radiation. A novel breast-specific stereotactic radiotherapy (BSRT) device (BSRTD) has been developed at our institution and has shown promise in delivering highly conformal dose distributions. We compared normal tissue sparing with this device with that achieved with intensity-modulated radiation therapy (IMRT)-PBI...
November 30, 2016: Oncology
https://www.readbyqxmd.com/read/27896976/missing-data-imputation-in-the-electronic-health-record-using-deeply-learned-autoencoders
#18
Brett K Beaulieu-Jones, Jason H Moore
Electronic health records (EHRs) have become a vital source of patient outcome data but the widespread prevalence of missing data presents a major challenge. Different causes of missing data in the EHR data may introduce unintentional bias. Here, we compare the effectiveness of popular multiple imputation strategies with a deeply learned autoencoder using the Pooled Resource Open-Access ALS Clinical Trials Database (PRO-ACT). To evaluate performance, we examined imputation accuracy for known values simulated to be either missing completely at random or missing not at random...
2016: Pacific Symposium on Biocomputing
https://www.readbyqxmd.com/read/27895542/effect-of-tart-cherry-juice-on-recovery-and-next-day-performance-in-well-trained-water-polo-players
#19
Rachel McCormick, Peter Peeling, Martyn Binnie, Brian Dawson, Marc Sim
BACKGROUND: Tart Montmorency cherries contain high concentrations of phytochemicals and anthocyanins, which have recently been linked to improved athletic recovery and subsequent performance. To date however, previous work reporting promising results has focused on land-based endurance sports, with any potential benefits to team sports remaining unknown. As such, this investigation set-out to examine the effect of supplemental tart cherry juice (CJ) on recovery and next day athletic performance in highly-trained water-based team sport athletes over seven days...
2016: Journal of the International Society of Sports Nutrition
https://www.readbyqxmd.com/read/27892650/application-of-bayesian-hierarchical-models-for-phase-i-ii-clinical-trials-in-oncology
#20
Shinjo Yada, Chikuma Hamada
Treatment during cancer clinical trials sometimes involves the combination of multiple drugs. In addition, in recent years there has been a trend toward phase I/II trials in which a phase I and a phase II trial are combined into a single trial to accelerate drug development. Methods for the seamless combination of phases I and II parts are currently under investigation. In the phase II part, adaptive randomization on the basis of patient efficacy outcomes allocates more patients to the dose combinations considered to have higher efficacy...
November 28, 2016: Pharmaceutical Statistics
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