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Clinical trial simulation

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https://www.readbyqxmd.com/read/28433500/psychometric-characteristics-of-the-matrics-consensus-cognitive-battery-in-a-large-pooled-cohort-of-stable-schizophrenia-patients
#1
Anastasia Georgiades, Vicki G Davis, Alexandra S Atkins, Anzalee Khan, Trina W Walker, Antony Loebel, George Haig, Dana C Hilt, Eduardo Dunayevich, Daniel Umbricht, Michael Sand, Richard S E Keefe
The MATRICS Consensus Cognitive Battery (MCCB) was developed to assess cognitive treatment effects in schizophrenia clinical trials, and is considered the FDA gold standard outcome measure for that purpose. The aim of the present study was to establish pre-treatment psychometric characteristics of the MCCB in a large pooled sample. The dataset included 2616 stable schizophrenia patients enrolled in 15 different clinical trials between 2007 and 2016 within the United States (94%) and Canada (6%). The MCCB was administered twice prior to the initiation of treatment in 1908 patients...
April 19, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28433383/screening-for-chronic-kidney-disease-in-canadian-indigenous-peoples-is-cost-effective
#2
Thomas W Ferguson, Navdeep Tangri, Zhi Tan, Matthew T James, Barry D A Lavallee, Caroline D Chartrand, Lorraine L McLeod, Allison B Dart, Claudio Rigatto, Paul V J Komenda
Canadian indigenous (First Nations) have rates of kidney failure that are 2- to 4-fold higher than the non-indigenous general Canadian population. As such, a strategy of targeted screening and treatment for CKD may be cost-effective in this population. Our objective was to assess the cost utility of screening and subsequent treatment for CKD in rural Canadian indigenous adults by both estimated glomerular filtration rate and the urine albumin-to-creatinine ratio. A decision analytic Markov model was constructed comparing the screening and treatment strategy to usual care...
April 19, 2017: Kidney International
https://www.readbyqxmd.com/read/28431428/computational-and-in-vitro-experimental-investigation-of-intrathecal-drug-distribution-parametric-study-of-the-effect-of-injection-volume-cerebrospinal-fluid-pulsatility-and-drug-uptake
#3
Kevin M Tangen, Roxanne Leval, Ankit I Mehta, Andreas A Linninger
BACKGROUND: Intrathecal drug delivery is an attractive option to circumvent the blood-brain barrier for pain management through its increased efficacy of pain relief, reduction in adverse side effects, and cost-effectiveness. Unfortunately, there are limited guidelines for physicians to choose infusion or drug pump settings to administer therapeutic doses to specific regions of the spine or the brain. Although empiric trialing of intrathecal drugs is critical to determine the sustained side effects, currently there is no inexpensive in vitro method to guide the selection of spinal drug delivery parameters...
May 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28427321/in-silico-assessment-of-biomedical-products-the-conundrum-of-rare-but-not-so-rare-events-in-two-case-studies
#4
Marco Viceconti, Claudio Cobelli, Tarek Haddad, Adam Himes, Boris Kovatchev, Mark Palmer
In silico clinical trials, defined as "The use of individualized computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention," have been proposed as a possible strategy to reduce the regulatory costs of innovation and the time to market for biomedical products. We review some of the the literature on this topic, focusing in particular on those applications where the current practice is recognized as inadequate, as for example, the detection of unexpected severe adverse events too rare to be detected in a clinical trial, but still likely enough to be of concern...
May 2017: Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine
https://www.readbyqxmd.com/read/28422820/comparison-of-the-etview-single-lumen-and-macintosh-laryngoscopes-for-endotracheal-intubation-in-an-airway-manikin-with-immobilized-cervical-spine-by-novice-paramedics-a-randomized-crossover-manikin-trial
#5
Pawel Gawlowski, Jacek Smereka, Marcin Madziala, Barak Cohen, Kurt Ruetzler, Lukasz Szarpak
CONTEXT: Management of the airway of a trauma victim is considered challenging. Various approaches have been described to achieve airway control in this setup; many of them include video-assited viewing of the larynx during intubation. ETView Single Lumen (SL) is a novice single-use endotracheal tube equiped with a video camera and a light source at its distal tip. Its use was previously described in seeral clinical and training setups. OBJECTIVE: The aim was to evaluate the efficacy of the VivaSight SL compared with classic direct laryngoscopy performed with a Macintosh blade in a manikin-simulated trauma setup presenting various degrees of airway challenge when performed by inexperienced physicians...
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28419486/population-pharmacokinetic-analysis-of-bortezomib-in-pediatric-leukemia-patients-model-based-support-for-body-surface-area-based-dosing-over-the-2-to-16-year-age-range
#6
Michael J Hanley, Diane R Mould, Timothy J Taylor, Neeraj Gupta, Kaveri Suryanarayan, Rachel Neuwirth, Dixie-Lee Esseltine, Terzah M Horton, Richard Aplenc, Todd A Alonzo, Xiaomin Lu, Ashley Milton, Karthik Venkatakrishnan
This population analysis described the pharmacokinetics of bortezomib after twice-weekly, repeat-dose, intravenous administration in pediatric patients participating in 2 clinical trials: the phase 2 AALL07P1 (NCT00873093) trial in relapsed acute lymphoblastic leukemia and the phase 3 AAML1031 (NCT01371981) trial in de novo acute myelogenous leukemia. The sources of variability in the pharmacokinetic parameters were characterized and quantified to support dosing recommendations. Patients received intravenous bortezomib 1...
April 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419480/characterization-of-neutropenia-in-advanced-cancer-patients-following-palbociclib-treatment-using-a-population-pharmacokinetic-pharmacodynamic-modeling-and-simulation-approach
#7
Wan Sun, Peter J O'Dwyer, Richard S Finn, Ana Ruiz-Garcia, Geoffrey I Shapiro, Gary K Schwartz, Angela DeMichele, Diane Wang
Neutropenia is the most commonly reported hematologic toxicity following treatment with palbociclib, a cyclin-dependent kinase 4/6 inhibitor approved for metastatic breast cancer. Using data from 185 advanced cancer patients receiving palbociclib in 3 clinical trials, a pharmacokinetic-pharmacodynamic model was developed to describe the time course of absolute neutrophil count (ANC) and quantify the exposure-response relationship for neutropenia. These analyses help in understanding neutropenia associated with palbociclib and its comparison with chemotherapy-induced neutropenia...
April 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419467/refining-liver-safety-risk-assessment-application-of-mechanistic-modeling-and-serum-biomarkers-to-cimaglermin-alfa-ggf2-clinical-trials
#8
Diane M Longo, Grant T Generaux, Brett A Howell, Scott Q Siler, Daniel J Antoine, Donald Button, Anthony Caggiano, Andrew Eisen, Jennifer Iaci, Ric Stanulis, Tom Parry, Merrie Mosedale, Paul B Watkins
Cimaglermin alfa (GGF2) is a recombinant human protein growth factor in development for heart failure. Phase 1 trials were suspended when 2 cimaglermin alfa-treated subjects experienced concomitant elevations in serum aminotransferases and total bilirubin meeting current FDA criteria for a serious liver safety signal (i.e. "Hy's Law"). We assayed mechanistic biomarkers in archived clinical trial serum samples which confirmed the hepatic origin of the aminotransferase elevations in these two subjects and identified apoptosis as the major mode of hepatocyte death...
April 17, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28419462/modeling-and-simulation-of-pivotal-clinical-trials-using-linked-models-for-multiple-endpoints-in-chronic-obstructive-pulmonary-disease-with-roflumilast
#9
Axel Facius, Andreas Krause, Laurent Claret, Rene Bruno, Gezim Lahu
Roflumilast is a selective phosphodiesterase 4 inhibitor (PDE4i) for the treatment of severe chronic obstructive pulmonary disease (COPD). In 2 large phase 3 trials in a broader population of COPD patients (BY217/M2-111, ClinicalTrials.gov: NCT00076089 and BY217/M2-112, ClinicalTrials.gov: NCT00430729), treatment with roflumilast reduced the rate of exacerbations; however, the reduction did not reach statistical significance. Two linked dose-response models for the primary (annualized COPD exacerbation counts) and secondary (change from baseline in forced expiratory volume in 1 second [FEV1 ]) end points were therefore developed to characterize and quantify effect sizes and the patient characteristics influencing them...
April 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419164/population-pharmacokinetic-modelling-of-rupatadine-solution-in-6-11-year-olds-and-optimisation-of-the-experimental-design-in-younger-children
#10
Eva Santamaría, Javier Alejandro Estévez, Jordi Riba, Iñaki Izquierdo, Marta Valle
AIMS: To optimise a pharmacokinetic (PK) study design of rupatadine for 2-5 year olds by using a population PK model developed with data from a study in 6-11 year olds. The design optimisation was driven by the need to avoid children's discomfort in the study. METHODS: PK data from 6-11 year olds with allergic rhinitis available from a previous study were used to construct a population PK model which we used in simulations to assess the dose to administer in a study in 2-5 year olds...
2017: PloS One
https://www.readbyqxmd.com/read/28412467/magnitude-and-direction-of-missing-confounders-had-different-consequences-on-treatment-effect-estimation-in-propensity-score-analysis
#11
Tri-Long Nguyen, Gary S Collins, Jessica Spence, Charles Fontaine, Jean-Pierre Daurès, P J Devereaux, Paul Landais, Yannick Le Manach
OBJECTIVE: Propensity score (PS) analysis allows an unbiased estimate of treatment effects, but assumes that all confounders are measured. We assessed the impact of omitting confounders from a PS analysis on clinical decision-making. STUDY DESIGN AND SETTING: We conducted Monte Carlo simulations on hypothetical observational studies based on virtual populations and on the population from a large randomized trial (CRASH-2). In both series of simulations, PS analysis was conducted with all confounders and with omitted confounders, which were defined to have different strengths of association with the outcome and treatment exposure...
April 12, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28410277/use-of-population-pharmacokinetics-and-electronic-health-records-to-assess-piperacillin-tazobactam-safety-in-infants
#12
Sara Salerno, Christoph P Hornik, Michael Cohen-Wolkowiez, P Brian Smith, Lawrence C Ku, Matthew S Kelly, Reese Clark, Daniel Gonzalez
BACKGROUND: Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infants, but measures of drug exposure are lacking. METHODS: To relate simulated piperacillin exposure with adverse events (AEs) in infants using EHR data, we identified infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012...
April 13, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28407203/on-the-multiple-imputation-variance-estimator-for-control-based-and-delta-adjusted-pattern-mixture-models
#13
Yongqiang Tang
Control-based pattern mixture models (PMM) and delta-adjusted PMMs are commonly used as sensitivity analyses in clinical trials with non-ignorable dropout. These PMMs assume that the statistical behavior of outcomes varies by pattern in the experimental arm in the imputation procedure, but the imputed data are typically analyzed by a standard method such as the primary analysis model. In the multiple imputation (MI) inference, Rubin's variance estimator is generally biased when the imputation and analysis models are uncongenial...
April 13, 2017: Biometrics
https://www.readbyqxmd.com/read/28406438/u-s-trends-of-ed-visits-for-pediatric-traumatic-brain-injuries-implications-for-clinical-trials
#14
Cheng Chen, Junxin Shi, Rachel M Stanley, Eric A Sribnick, Jonathan I Groner, Henry Xiang
Our goal in this paper was to use the 2006-2013 Nationwide Emergency Department Sample (NEDS) database to describe trends of annual patient number, patient demographics and hospital characteristics of pediatric traumatic brain injuries (TBI) treated in U.S. emergency departments (EDs); and to use the same database to estimate the available sample sizes for various clinical trials of pediatric TBI cases. National estimates of patient demographics and hospital characteristics were calculated for pediatric TBI...
April 13, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28402417/grandmaternal-smoke-exposure-reduces-female-fertility-in-a-murine-model-with-great-grandmaternal-smoke-exposure-unlikely-to-have-an-effect
#15
N J Camlin, A G Jarnicki, R L Vanders, K A Walters, P M Hansbro, E A McLaughlin, J E Holt
STUDY QUESTION: What effect does multigenerational (F2) and transgenerational (F3) cigarette smoke exposure have on female fertility in mice? SUMMARY ANSWER: Cigarette smoking has a multigenerational effect on female fertility. WHAT IS KNOWN ALREADY: It has been well established that cigarette smoking decreases female fertility. Furthermore, a growing body of evidence suggests that smoking during pregnancy decreases the fertility of daughters and increases cancer and asthma incidence in grandchildren and great-grandchildren...
April 10, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28402385/does-choice-of-influenza-vaccine-type-change-disease-burden-and-cost-effectiveness-in-the-united-states-an-agent-based-modeling-study
#16
Jay V DePasse, Kenneth J Smith, Jonathan M Raviotta, Eunha Shim, Mary Patricia Nowalk, Richard K Zimmerman, Shawn T Brown
Offering a choice of influenza vaccine type may increase vaccine coverage and reduce disease burden, but it is more costly. This study calculated the public health impact and cost-effectiveness of 4 strategies: no choice, pediatric choice, adult choice, or choice for both age groups. Using agent-based modeling, individuals were simulated as they interacted with others, and influenza was tracked as it spread through a population in Washington, DC. Influenza vaccination coverage derived from data from the Centers for Disease Control and Prevention was increased by 6...
April 10, 2017: American Journal of Epidemiology
https://www.readbyqxmd.com/read/28401674/placebo-like-response-in-absence-of-treatment-in-children-with-autism
#17
Rebecca M Jones, Caroline Carberry, Amarelle Hamo, Catherine Lord
Caregiver report is the most common measure of change in pediatric psychiatry. Yet, placebo response rates pose significant challenges to reliably detect a treatment response. The present study simulated an eight-week clinical trial protocol for Autism Spectrum Disorder (ASD) for the purpose of testing the feasibility and validity of several outcome measures. Twenty caregivers answered questions about their child's behavior on their smartphone each week and completed a battery of paper questionnaires during weeks one and eight...
April 12, 2017: Autism Research: Official Journal of the International Society for Autism Research
https://www.readbyqxmd.com/read/28399648/the-highly-selective-caspase-1-inhibitor-vx-765-provides-additive-protection-against-myocardial-infarction-in-rat-hearts-when-combined-with-a-platelet-inhibitor
#18
Xi-Ming Yang, James M Downey, Michael V Cohen, Nicole A Housley, Diego F Alvarez, Jonathon P Audia
Use of ischemic postconditioning and other related cardioprotective interventions to treat patients with acute myocardial infarction (AMI) has failed to improve outcomes in clinical trials. Because P2Y12 inhibitors are themselves postconditioning mimetics, it has been postulated that the loading dose of platelet inhibitors routinely given to patients treated for AMI masks the anti-infarct effect of other intended cardioprotective interventions. To further improve outcomes of patients with AMI, an intervention must be able to provide additive protection in the presence of a P2Y12 platelet inhibitor...
January 1, 2017: Journal of Cardiovascular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28392614/a-virtual-clinical-trial-using-projection-based-nodule-insertion-to-determine-radiologist-reader-performance-in-lung-cancer-screening-ct
#19
Lifeng Yu, Qiyuan Hu, Chi Wan Koo, Edwin A Takahashi, David L Levin, Tucker F Johnson, Megan J Hora, Shane Dirks, Baiyu Chen, Kyle McMillan, Shuai Leng, J G Fletcher, Cynthia H McCollough
Task-based image quality assessment using model observers is promising to provide an efficient, quantitative, and objective approach to CT dose optimization. Before this approach can be reliably used in practice, its correlation with radiologist performance for the same clinical task needs to be established. Determining human observer performance for a well-defined clinical task, however, has always been a challenge due to the tremendous amount of efforts needed to collect a large number of positive cases. To overcome this challenge, we developed an accurate projection-based insertion technique...
February 11, 2017: Proceedings of SPIE
https://www.readbyqxmd.com/read/28389762/analysis-of-opioid-consumption-in-clinical-trials-a-simulation-based-analysis-of-power-of-four-approaches
#20
Rasmus Vestergaard Juul, Joakim Nyberg, Mads Kreilgaard, Lona Louring Christrup, Ulrika S H Simonsson, Trine Meldgaard Lund
Inconsistent trial design and analysis is a key reason that few advances in postoperative pain management have been made from clinical trials analyzing opioid consumption data. This study aimed to compare four different approaches to analyze opioid consumption data. A repeated time-to-event (RTTE) model in NONMEM was used to simulate clinical trials of morphine consumption with and without a hypothetical adjuvant analgesic in doses equivalent to 15-62% reduction in morphine consumption. Trials were simulated with duration of 24-96 h...
April 7, 2017: Journal of Pharmacokinetics and Pharmacodynamics
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