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Clinical trial simulation

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https://www.readbyqxmd.com/read/29355783/a-standard-driven-approach-for-electronic-submission-to-pharmaceutical-regulatory-authorities
#1
Ching-Heáng Lin, Hsin-I Chou, Ueng-Cheng Yang
OBJECTIVE: Using standards is not only useful for data interchange during the process of a clinical trial, but also useful for analyzing data in a review process. Any step, which speeds up approval of new drugs, may benefit patients. As a result, adopting standards for regulatory submission becomes mandatory in some countries. However, preparing standard-compliant documents, such as annotated case report form (aCRF), needs a great deal of knowledge and experience. The process is complex and labor-intensive...
January 18, 2018: Journal of Biomedical Informatics
https://www.readbyqxmd.com/read/29355231/pre-exposure-prophylaxis-for-hiv-negative-persons-with-partners-living-with-hiv-uptake-use-and-effectiveness-in-an-open-label-demonstration-project-in-east-africa
#2
Renee Heffron, Kenneth Ngure, Josephine Odoyo, Nulu Bulya, Edna Tindimwebwa, Ting Hong, Lara Kidoguchi, Deborah Donnell, Nelly R Mugo, Elizabeth A Bukusi, Elly Katabira, Stephen Asiimwe, Jennifer Morton, Susan Morrison, Harald Haugen, Andrew Mujugira, Jessica E Haberer, Norma C Ware, Monique A Wyatt, Mark A Marzinke, Lisa M Frenkel, Connie Celum, Jared M Baeten
Introduction: Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk, such as individuals with a partner living with HIV.  Demonstration projects of PrEP have been conducted in diverse settings worldwide to illustrate practical examples of how PrEP can be delivered.  Methods: We evaluated delivery of PrEP for HIV-negative partners within heterosexual HIV serodiscordant couples in an open-label demonstration project in East Africa...
November 6, 2017: Gates Open Res
https://www.readbyqxmd.com/read/29355082/use-of-interval-estimations-in-design-and-evaluation-of-multiregional-clinical-trials-with-continuous-outcomes
#3
Chieh Chiang, Chin-Fu Hsiao
Multiregional clinical trials have been accepted in recent years as a useful means of accelerating the development of new drugs and abridging their approval time. The statistical properties of multiregional clinical trials are being widely discussed. In practice, variance of a continuous response may be different from region to region, but it leads to the assessment of the efficacy response falling into a Behrens-Fisher problem-there is no exact testing or interval estimator for mean difference with unequal variances...
January 1, 2018: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29354991/-chronic-fatigue-syndrome-treated-with-transcutaneous-electrical-acupoint-stimulation-a-randomized-controlled-trial
#4
Jinxia Li, Jingjun Xie, Zhongqiang Pan, Xiaoqing Guo, Ye Li, Ruiyang Fu
OBJECTIVE: To evaluate the clinical therapeutic effects and safety of chronic fatigue syndrome treated with transcutaneous electrical acupoint stimulation (TEAS) on the conception vessel and the governor vessel. METHODS: Eighty-nine patients of chronic fatigue syndrome were randomized into an observation group (46 cases) and a control group (43 cases). In the observation group, TEAS was applied at Dazhui (GV 14) and Mingmen (GV 4), Shenque (CV 8) and Guanyuan (CV 4) [the current intensity: (14±2) mA]...
December 12, 2017: Zhongguo Zhen Jiu, Chinese Acupuncture & Moxibustion
https://www.readbyqxmd.com/read/29353335/leveraging-model-informed-approaches-for-drug-discovery-and-development-in-the-cardiovascular-space
#5
REVIEW
Marissa F Dockendorf, Ryan C Vargo, Ferdous Gheyas, Anne S Y Chain, Manash S Chatterjee, Larissa A Wenning
Cardiovascular disease remains a significant global health burden, and development of cardiovascular drugs in the current regulatory environment often demands large and expensive cardiovascular outcome trials. Thus, the use of quantitative pharmacometric approaches which can help enable early Go/No Go decision making, ensure appropriate dose selection, and increase the likelihood of successful clinical trials, have become increasingly important to help reduce the risk of failed cardiovascular outcomes studies...
January 20, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29351759/tracheal-intubation-in-critically-ill-patients-a-comprehensive-systematic-review-of-randomized-trials
#6
Luca Cabrini, Giovanni Landoni, Martina Baiardo Radaelli, Omar Saleh, Carmine D Votta, Evgeny Fominskiy, Alessandro Putzu, Cézar Daniel Snak de Souza, Massimo Antonelli, Rinaldo Bellomo, Paolo Pelosi, Alberto Zangrillo
BACKGROUND: We performed a systematic review of randomized controlled studies evaluating any drug, technique or device aimed at improving the success rate or safety of tracheal intubation in the critically ill. METHODS: We searched PubMed, BioMed Central, Embase and the Cochrane Central Register of Clinical Trials and references of retrieved articles. Finally, pertinent reviews were also scanned to detect further studies until May 2017. The following inclusion criteria were considered: tracheal intubation in adult critically ill patients; randomized controlled trial; study performed in Intensive Care Unit, Emergency Department or ordinary ward; and work published in the last 20 years...
January 20, 2018: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/29349708/cost-effectiveness-of-empagliflozin-for-the-treatment-of-patients-with-type-2-diabetes-mellitus-at-increased-cardiovascular-risk-in-greece
#7
George Gourzoulidis, Charalampos Tzanetakos, Ioannis Ioannidis, Apostolos Tsapas, Georgia Kourlaba, Giannis Papageorgiou, Nikos Maniadakis
BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece...
January 18, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29344794/ticagrelor-for-secondary-prevention-of-atherothrombotic-events-after-myocardial-infarction-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#8
REVIEW
Xavier G L V Pouwels, Robert Wolff, Bram L T Ramaekers, Anoukh Van Giessen, Shona Lang, Steve Ryder, Gill Worthy, Steven Duffy, Nigel Armstrong, Jos Kleijnen, Manuela A Joore
The National Institute for Health and Care Excellence (NICE) invited AstraZeneca, the manufacturer of ticagrelor (Brilique®), to submit evidence on the clinical and cost effectiveness of ticagrelor 60 mg twice daily (BID) in combination with low-dose aspirin [acetylsalicylic acid (ASA)] compared with ASA only for secondary prevention of atherothrombotic events in patients with a history of myocardial infarction (MI) and who are at increased risk of atherothrombotic events. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Maastricht University Medical Centre+, was commissioned as the evidence review group (ERG)...
January 18, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29341205/promotion-time-cure-rate-model-with-nonparametric-form-of-covariate-effects
#9
Tianlei Chen, Pang Du
Survival data with a cured portion are commonly seen in clinical trials. Motivated from a biological interpretation of cancer metastasis, promotion time cure model is a popular alternative to the mixture cure rate model for analyzing such data. The existing promotion cure models all assume a restrictive parametric form of covariate effects, which can be incorrectly specified especially at the exploratory stage. In this paper, we propose a nonparametric approach to modeling the covariate effects under the framework of promotion time cure model...
January 17, 2018: Statistics in Medicine
https://www.readbyqxmd.com/read/29341179/better-characterization-of-vinflunine-pharmacokinetics-variability-and-exposure-toxicity-relationship-to-improve-its-use-analyses-from-18-trials
#10
A Schmitt, L Nguyen, G Zorza, P Ferré, A Pétain
AIMS: Vinflunine is a novel tubulin-targeted inhibitor indicated as a single agent for the treatment of bladder cancers after failure of prior platinum-based therapy. Its pharmacokinetics (PK) and pharmacodynamics (PD) have been independently characterized through several phase I and phase II studies. However, no global pharmacometric analysis had been conducted yet. METHODS: Vinflunine concentrations and safety data from 18 phase I and phase II studies were used to conduct population PK and PK/PD analysis, using Nonmem...
January 17, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29339394/population-pharmacokinetics-of-finafloxacin-in-healthy-volunteers-and-patients-with-complicated-urinary-tract-infections
#11
Max Taubert, Mark Lückermann, Andreas Vente, Axel Dalhoff, Uwe Fuhr
Background: Finafloxacin is a novel fluoroquinolone with increased antibacterial activity at acidic pH and reduced susceptibility to several resistance mechanisms. A phase II study revealed a good efficacy/safety profile in patients with complicated urinary tract infections (cUTI) while pharmacokinetics was characterized by highly variable concentration vs. time profiles, suggesting the need for an elaborated pharmacokinetic model.Methods: Data from three clinical trials were evaluated; 127 healthy volunteers were dosed orally (N=77) or intravenously (N=50) and 139 patients with cUTI received finafloxacin intravenously...
January 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29336696/controlled-adverse-environment-chambers-in-dry-eye-research
#12
Margarita Calonge, Marc Labetoulle, Elisabeth M Messmer, Sunil Shah, Yonca A Akova, Kostas G Boboridis, Jesús Merayo-Lloves, Pasquale Aragona, José Benítez-Del-Castillo, Gerd Geerling, Maurizio Rolando, Christophe Baudouin
Dry eye disease (DED) is a common condition with signs and symptoms that vary depending on a wide range of environmental factors to which people are exposed in their daily lives. Factors such as variable temperature, airflow velocity, relative humidity, seasonality, and pollutants can alter the rate of tear film evaporation, improving or exacerbating symptoms of DED. Results from currently available clinical tests do not always correlate well with patient-reported symptoms, and the continually changing environment and variability in DED symptoms present challenges for the design and conduct of clinical trials...
January 16, 2018: Current Eye Research
https://www.readbyqxmd.com/read/29333672/controlled-pattern-imputation-for-sensitivity-analysis-of-longitudinal-binary-and-ordinal-outcomes-with-nonignorable-dropout
#13
Yongqiang Tang
The controlled imputation method refers to a class of pattern mixture models that have been commonly used as sensitivity analyses of longitudinal clinical trials with nonignorable dropout in recent years. These pattern mixture models assume that participants in the experimental arm after dropout have similar response profiles to the control participants or have worse outcomes than otherwise similar participants who remain on the experimental treatment. In spite of its popularity, the controlled imputation has not been formally developed for longitudinal binary and ordinal outcomes partially due to the lack of a natural multivariate distribution for such endpoints...
January 15, 2018: Statistics in Medicine
https://www.readbyqxmd.com/read/29332554/evaluating-the-dose-dependent-mechanism-of-action-of-trazodone-by-estimation-of-occupancies-for-different-brain-neurotransmitter-targets
#14
Luca Settimo, David Taylor
Trazodone is a drug that was introduced in the clinic almost 40 years ago. It is licensed to treat depression, but it is also commonly used off-label to treat insomnia. A recent study shows that it could be promising in preventing neurodegeneration in mice, and clinical trials to assess its possible beneficial effects on dementia and Alzheimer's disease are expected to start soon in humans. In this study, we describe the dose-dependent pharmacology of trazodone by carrying out pharmacokinetic simulations aiming to predict the brain concentrations of trazodone for different drug-dosing regimens and calculating occupancy for 28 different targets for which published trazodone-binding data are available...
January 2018: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/29329996/to-prep-or-not-to-prep-that-is-the-question-a-randomized-trial-on-the-use-of-antiflatulent-medication-as-part-of-bowel-preparation-for-patients-having-image-guided-external-beam-radiation-therapy-to-the-prostate
#15
Merrylee McGuffin, Naila Devji, Lyann Kehoe, Anne Carty, Steve Russell, Lisa Di Prospero, Carlo DeAngelis, Alex Kiss, Danny Vesprini, Andrew Loblaw, Laura D'Alimonte
INTRODUCTION: Radiation therapy is a standard treatment option for prostate cancer. With growing use of escalated doses and tighter margins, procedures to limit rectal size variation are needed to reduce prostate motion, increase treatment accuracy, and minimize rectal toxicity. This prospective study was done to determine whether the introduction of an antiflatulent medication would decrease rectal distention at computed tomography (CT) simulation and throughout a course of radiation therapy...
November 4, 2017: Practical Radiation Oncology
https://www.readbyqxmd.com/read/29326414/-effect-of-debriefing-based-on-the-clinical-judgment-model-on-simulation-based-learning-outcomes-of-end-of-life-care-for-nursing-students-a-non-randomized-controlled-trial
#16
Kyung In Jeong, Ja Yun Choi
PURPOSE: This study was conducted to identify effects of debriefing based on the clinical judgment model for nursing students on their knowledge, skill performance, clinical judgment, self-confidence and learner satisfaction during simulation based end-of-life care (ELC) education. METHODS: Simulation based ELC education was developed in six steps as follows: selection of learning subjects and objects, development of learning tools, a trial run of simulation-based education, students' skill training, and evaluators' training...
December 2017: Journal of Korean Academy of Nursing
https://www.readbyqxmd.com/read/29324411/virtual-activities-of-daily-living-for-recovery-of-upper-extremity-motor-function
#17
Richard J Adams, Matthew D Lichter, Allison Ellington, Marga White, Kate Armstead, James T Patrie, Paul T Diamond
A study was conducted to investigate the effectiveness of virtual activities of daily living (ADL) practice using the SaeboVR software system for the recovery of upper extremity (UE) motor function following stroke. The system employs Kinect sensor-based tracking to translate human UE motion into the anatomical pose of the arm of the patient's avatar within a virtual environment, creating a virtual presence within a simulated task space. Patients gain mastery of 12 different integrated activities while traversing a metaphorical "road to recovery" that includes thematically linked levels and therapist-selected difficulty settings...
January 2018: IEEE Transactions on Neural Systems and Rehabilitation Engineering
https://www.readbyqxmd.com/read/29324183/technologies-for-measuring-pharmacokinetic-profiles
#18
A A Heller, S Y Lockwood, T M Janes, D M Spence
The creation of a pharmacokinetic (PK) curve, which follows the plasma concentration of an administered drug as a function of time, is a critical aspect of the drug development process and includes such information as the drug's bioavailability, clearance, and elimination half-life. Prior to a drug of interest gaining clearance for use in human clinical trials, research is performed during the preclinical stages to establish drug safety and dosing metrics from data obtained from the PK studies. Both in vivo animal models and in vitro platforms have limitations in predicting human reaction to a drug due to differences in species and associated simplifications, respectively...
January 11, 2018: Annual Review of Analytical Chemistry
https://www.readbyqxmd.com/read/29320694/dynamic-structural-differences-between-human-and-mouse-sting-lead-to-differing-sensitivity-to-dmxaa
#19
Amy Y Shih, Kelly L Damm-Ganamet, Taraneh Mirzadegan
The stimulator-of-interferon-genes (STING) protein is involved in innate immunity. It has recently been shown that modulation of STING can lead to an aggressive antitumor response. DMXAA is an antitumor agent that had shown great promise in murine models but failed in human clinical trials. The molecular target of DMXAA was subsequently shown to be murine STING (mSTING); however, human STING (hSTING) is insensitive to DMXAA. Molecular dynamics simulations were employed to investigate the differences between hSTING and mSTING that could influence DMXAA binding...
January 9, 2018: Biophysical Journal
https://www.readbyqxmd.com/read/29319155/economic-evaluation-and-cost-of-interventions-for-cerebral-palsy-a-systematic-review
#20
REVIEW
Sophy T F Shih, Utsana Tonmukayakul, Christine Imms, Dinah Reddihough, H Kerr Graham, Liz Cox, Rob Carter
AIM: Economic appraisal can help guide policy-making for purchasing decisions, and treatment and management algorithms for health interventions. We conducted a systematic review of economic studies in cerebral palsy (CP) to inform future research. METHOD: Economic studies published since 1970 were identified from seven databases. Two reviewers independently screened abstracts and extracted data following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines...
January 10, 2018: Developmental Medicine and Child Neurology
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