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Clinical trial simulation

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https://www.readbyqxmd.com/read/29148070/growth-factors-for-diabetic-foot-ulcers-mixed-treatment-comparison-analysis-of-randomized-clinical-trials
#1
Kannan Sridharan, Gowri Sivaramakrishnan
AIMS: Topical growth factors accelerate wound healing in patients with diabetic foot ulcers (DFU). Due to the absence of head to head comparisons, we carried out Bayesian network meta-analysis to compare the efficacy and safety of growth factors. METHODS: Using an appropriate search strategy, randomized controlled trials on topical growth factors compared with standard of care in patients with DFU, were included. Proportion of patients with complete healing was the primary outcome...
November 17, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29145886/are-mice-good-models-for-human-neuromuscular-disease-comparing-muscle-excursions-in-walking-between-mice-and-humans
#2
Xiao Hu, James P Charles, Turgay Akay, John R Hutchinson, Silvia S Blemker
BACKGROUND: The mouse is one of the most widely used animal models to study neuromuscular diseases and test new therapeutic strategies. However, findings from successful pre-clinical studies using mouse models frequently fail to translate to humans due to various factors. Differences in muscle function between the two species could be crucial but often have been overlooked. The purpose of this study was to evaluate and compare muscle excursions in walking between mice and humans. METHODS: Recently published musculoskeletal models of the mouse hindlimb and human lower limb were used to simulate muscle-tendon dynamics during mouse and human walking, a key daily activity...
November 16, 2017: Skeletal Muscle
https://www.readbyqxmd.com/read/29145878/improving-readiness-for-recruitment-through-simulated-trial-activation-the-adjuvant-steroids-in-adults-with-pandemic-influenza-asap-trial
#3
Wei Shen Lim, Garry Meakin, Clare Brittain, Thomas Bewick, Lelia Duley
BACKGROUND: Research in public health emergencies requires trials to be set up in readiness for activation at short notice and in anticipation of limited timelines for patient recruitment. We conducted a simulated activation of a hibernating pandemic influenza clinical trial in order to test trial processes and to determine the value of such simulation in maintaining trial readiness. METHODS: The simulation involved the Nottingham Clinical Trials Unit, one participating hospital, one manufacturing unit and the Investigational Medicinal Product (IMP) supplier...
November 16, 2017: Trials
https://www.readbyqxmd.com/read/29143400/pharmacokinetics-of-concentrated-naloxone-nasal-spray-for-opioid-overdose-reversal-phase-i-healthy-volunteer-study
#4
Rebecca McDonald, Ulrike Lorch, Jo Woodward, Björn Bosse, Helen Dooner, Gill Mundin, Kevin Smith, John Strang
BACKGROUND AND AIMS: Take-home naloxone can prevent death from heroin/opioid overdose, but pre-provision is difficult because naloxone is usually given by injection. Non-injectable alternatives, including naloxone nasal sprays, are currently being developed. To be effective, the intranasal (i.n.) spray dose must be adequate but not excessive, and early absorption must be comparable to intramuscular (i.m.) injection. We report on the pharmacokinetics (PK) of a specially produced concentrated novel nasal spray...
November 16, 2017: Addiction
https://www.readbyqxmd.com/read/29141153/using-observational-data-to-calibrate-simulation-models
#5
Eleanor J Murray, James M Robins, George R Seage, Sara Lodi, Emily P Hyle, Krishna P Reddy, Kenneth A Freedberg, Miguel A Hernán
BACKGROUND: Individual-level simulation models are valuable tools for comparing the impact of clinical or public health interventions on population health and cost outcomes over time. However, a key challenge is ensuring that outcome estimates correctly reflect real-world impacts. Calibration to targets obtained from randomized trials may be insufficient if trials do not exist for populations, time periods, or interventions of interest. Observational data can provide a wider range of calibration targets but requires methods to adjust for treatment-confounder feedback...
November 1, 2017: Medical Decision Making: An International Journal of the Society for Medical Decision Making
https://www.readbyqxmd.com/read/29140414/dose-finding-designs-for-cumulative-toxicities-using-multiple-constraints
#6
Shing M Lee, Moreno Ursino, Ying Kuen Cheung, Sarah Zohar
This article addresses the concern regarding late-onset dose-limiting toxicities (DLT), moderate toxicities below the threshold of a DLT and cumulative toxicities that may lead to a DLT, which are mostly disregarded or handled in an ad hoc manner when determining the maximum tolerated dose (MTD) in dose-finding cancer clinical trials. An extension of the Time-to-Event Continual Reassessment Method (TITE-CRM) which allows for the specification of toxicity constraints on both DLT and moderate toxicities, and can account for partial information is proposed...
November 13, 2017: Biostatistics
https://www.readbyqxmd.com/read/29138584/repeated-intermittent-ulipristal-acetate-in-the-treatment-of-uterine-fibroids-a-cost-effectiveness-analysis
#7
Kirk Geale, Ertan Saridogan, Matthieu Lehmann, Pablo Arriagada, Marcus Hultberg, Martin Henriksson
There are limited treatment options available for women with moderate to severe symptoms of uterine fibroids (UFs) who wish to avoid surgery. For these women, treatment with standard pharmaceuticals such as contraceptives is often insufficient to relieve symptoms, and patients may require surgery despite their wish to avoid it. Clinical trials demonstrate that ulipristal acetate 5 mg (UPA) is an effective treatment for this patient group, but its cost-effectiveness has not been assessed in this population. A decision-analytic model was developed to simulate a cohort of patients in this population under treatment with UPA followed by surgery as needed compared to treatment with iron and non-steroidal anti-inflammatory drug (NSAID) followed by surgery as needed (best supportive care, BSC)...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29135775/adjustment-for-variable-adherence-under-hierarchical-structure-instrumental-variable-modeling-through-compound-residual-inclusion
#8
Tyson H Holmes, Donna M Zulman, Clete A Kushida
BACKGROUND: Variable adherence to assigned conditions is common in randomized clinical trials. OBJECTIVES: A generalized modeling framework under longitudinal data structures is proposed for regression estimation of the causal effect of variable adherence on outcome, with emphasis upon adjustment for unobserved confounders. RESEARCH DESIGN: A nonlinear, nonparametric random-coefficients modeling approach is described. Estimates of local average treatment effects among compliers can be obtained simultaneously for all assigned conditions to which participants are randomly assigned within the trial...
December 2017: Medical Care
https://www.readbyqxmd.com/read/29133566/use-of-pharmacokinetic-and-pharmacodynamic-analyses-to-determine-the-optimal-fixed-dosing-regimen-of-iclaprim-for-treatment-of-serious-gram-positive-infections
#9
Thomas Lodise, John Bosso, Colleen Kelly, Paul J Williams, James R Lane, David B Huang
Iclaprim is a bacterial dihydrofolate reductase inhibitor that is currently being evaluated in two Phase 3 trials for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Prior animal infection models studies suggest that the pharmacokinetic and pharmacodynamics (PK/PD) drivers for efficacy are area under the curve from 0-24 hours at steady state (AUC0-24hss), AUC/minimum inhibitory concentration (MIC), and time above the MIC during the dosing interval (T > MIC) while QTc prolongation was associated to maximal concentration at steady state (Cmaxss) in a thorough QTc Phase 1 study...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29126314/cost-effectiveness-analysis-of-nivolumab-for-treatment-of-platinum-resistant-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck
#10
Kathryn R Tringale, Kate T Carroll, Kaveh Zakeri, Assuntina G Sacco, Linda Barnachea, James D Murphy
Background: The CheckMate 141 trial found that nivolumab improved survival for patients with recurrent or metastatic head and neck cancer (HNC). Despite the improved survival, nivolumab is much more expensive than standard therapies. This study assesses the cost-effectiveness of nivolumab for the treatment of HNC. Methods: We constructed a Markov model to simulate treatment with nivolumab or standard single-agent therapy for patients with recurrent or metastatic platinum-refractory HNC...
November 3, 2017: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/29125220/a-dynamic-power-prior-for-borrowing-historical-data-in-noninferiority-trials-with-binary-endpoint
#11
G Frank Liu
Traditionally, noninferiority hypotheses have been tested using a frequentist method with a fixed margin. Given that information for the control group is often available from previous studies, it is interesting to consider a Bayesian approach in which information is "borrowed" for the control group to improve efficiency. However, construction of an appropriate informative prior can be challenging. In this paper, we consider a hybrid Bayesian approach for testing noninferiority hypotheses in studies with a binary endpoint...
November 10, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29124676/cost-effectiveness-analysis-of-the-gonadotropin-treatments-hp-hmg-and-rfsh-for-assisted-reproductive-technology-in-france-a-markov-model-analysis
#12
Paul Barriere, Géraldine Porcu-Buisson, Samir Hamamah
OBJECTIVES: The objectives of this study were to assess (1) the expected cost of a live birth (LB) after in vitro fertilization with two different gonadotropin treatments [high purified human menopausal gonadotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH)] as the single cost variable, and (2) the cost effectiveness of HP-hMG relative to rFSH in the context of the routine practice of assisted reproductive technology (ART) in France. METHODS: A Markov model was developed to simulate the therapeutic management, the in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) courses, and the effects of complications in hypothetical cohorts of 30,000 patients undergoing IVF/ICSI with fresh embryo transfer (up to four attempts) using data from the MERIT and MEGASET clinical trials or from French routine ART practice...
November 9, 2017: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/29122445/a-method-for-the-topographical-identification-and-quantification-of-high-frequency-oscillations-in-intracranial-electroencephalography-recordings
#13
Zachary J Waldman, Shoichi Shimamoto, Inkyung Song, Iren Orosz, Anatol Bragin, Itzhak Fried, Jerome Engel, Richard Staba, Michael R Sperling, Shennan A Weiss
OBJECTIVE: To develop a reliable software method using a topographic analysis of time-frequency plots to distinguish ripple (80-200 Hz) oscillations that are often associated with EEG sharp waves or spikes (RonS) from sinusoid-like waveforms that appear as ripples but correspond with digital filtering of sharp transients contained in the wide bandwidth EEG. METHODS: A custom algorithm distinguished true from false ripples in one second intracranial EEG (iEEG) recordings using wavelet convolution, identifying contours of isopower, and categorizing these contours into sets of open or closed loop groups...
October 21, 2017: Clinical Neurophysiology: Official Journal of the International Federation of Clinical Neurophysiology
https://www.readbyqxmd.com/read/29121828/preference-option-randomized-design-pord-for-comparative-effectiveness-research-statistical-power-for-testing-comparative-effect-preference-effect-selection-effect-intent-to-treat-effect-and-overall-effect
#14
Moonseong Heo, Paul Meissner, Alain H Litwin, Julia H Arnsten, M Diane McKee, Alison Karasz, Paula McKinley, Colin D Rehm, Earle C Chambers, Ming-Chin Yeh, Judith Wylie-Rosett
Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29116303/non-invasive-brain-stimulation-and-computational-models-in-post-stroke-aphasic-patients-single-session-of-transcranial-magnetic-stimulation-and-transcranial-direct-current-stimulation-a-randomized-clinical-trial
#15
Michele Devido Dos Santos, Vitor Breseghello Cavenaghi, Ana Paula Machado Goyano Mac-Kay, Vitor Serafim, Alexandre Venturi, Dennis Quangvinh Truong, Yu Huang, Paulo Sérgio Boggio, Felipe Fregni, Marcel Simis, Marom Bikson, Rubens José Gagliardi
CONTEXT AND OBJECTIVE: Patients undergoing the same neuromodulation protocol may present different responses. Computational models may help in understanding such differences. The aims of this study were, firstly, to compare the performance of aphasic patients in naming tasks before and after one session of transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS) and sham, and analyze the results between these neuromodulation techniques; and secondly, through computational model on the cortex and surrounding tissues, to assess current flow distribution and responses among patients who received tDCS and presented different levels of results from naming tasks...
November 6, 2017: São Paulo Medical Journal, Revista Paulista de Medicina
https://www.readbyqxmd.com/read/29115209/exploring-the-use-of-ingenol-mebutate-to-prevent-non-melanoma-skin-cancer
#16
Andrés Már Erlendsson
Non-melanoma skin cancer is the most frequently occurring cancer in Caucasians today. Incidence rates in Europe have increased steadily since the 1960s and more than tripled over the last 50 years. Despite primary preventative efforts, incidences of non-melanoma skin cancer continue to rise and development of effective chemopreventative strategies is needed. In 2013, ingenol mebutate was approved in Denmark as a new topical drug for field-directed treatment for actinic keratoses. Ingenol mebutate has a dual mechanism of action, causing initial cell death, followed by an immune activation...
November 2017: Danish Medical Journal
https://www.readbyqxmd.com/read/29110613/a-biomarker-combining-imaging-and-neuropsychological-assessment-for-tracking-early-alzheimer-s-disease-in-clinical-trials
#17
Nishant Verma, S Natasha Beretvas, Belen Pascual, Joseph C Masdeu, Mia K Markey, The Alzheimer S Disease Neuroimaging Initiative
BACKGROUND: Combining optimized cognitive (Alzheimer's Disease Assessment Scale-Cognitive subscale, ADAS-Cog) and atrophy markers of Alzheimer's disease for tracking progression in clinical trials may provide greater sensitivity than currently used methods, which have yielded negative results in multiple recent trials. Furthermore, it is critical to clarify the relationship among the subcomponents yielded by cognitive and imaging testing, to address the symptomatic and anatomical variability of Alzheimer's disease...
November 6, 2017: Current Alzheimer Research
https://www.readbyqxmd.com/read/29110140/economic-evaluation-of-implementing-a-novel-pharmacogenomic-test-idgenetix-%C3%A2-to-guide-treatment-of-patients-with-depression-and-or-anxiety
#18
Mehdi Najafzadeh, Jorge A Garces, Alejandra Maciel
BACKGROUND: The response to therapeutics varies widely in patients with depression and anxiety, making selection of an optimal treatment choice challenging. IDgenetix(®), a novel pharmacogenomic test, has been shown to improve outcomes by predicting the likelihood of response to different psychotherapeutic medications. OBJECTIVE: The objective of this study was to estimate the cost effectiveness of implementing a novel pharmacogenomic test (IDgenetix(®)) to guide treatment choices in patients with depression and/or anxiety compared with treatment as usual from the US societal perspective...
November 6, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29103925/challenges-of-assessing-therapeutic-or-diagnostic-outcomes-with-observational-data
#19
William S Weintraub, Robert W Yeh
• Observational assessments of therapeutic or diagnostic options are subject to treatment selection bias. • Statistical methods can reduce treatment selection bias cannot account for unmeasured confounders. • Simulation modeling can help assess whether there is residual selection bias. • Sample size cannot overcome bias. • Data are most believable when randomized clinical trial data and observational point in the same direction.
November 2, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/29103755/a-failure-type-specific-risk-prediction-tool-for-selection-of-head-and-neck-cancer-patients-for-experimental-treatments
#20
Katrin Håkansson, Jacob H Rasmussen, Gregers B Rasmussen, Jeppe Friborg, Thomas A Gerds, Barbara Malene Fischer, Flemming L Andersen, Søren M Bentzen, Lena Specht, Ivan R Vogelius
OBJECTIVES: The objective of this work was to develop a tool for decision support, providing simultaneous predictions of the risk of loco-regional failure (LRF) and distant metastasis (DM) after definitive treatment for head-and-neck squamous cell carcinoma (HNSCC). MATERIALS AND METHODS: Retrospective data for 560HNSCC patients were used to generate a multi-endpoint model, combining three cause-specific Cox models (LRF, DM and death with no evidence of disease (death NED))...
November 2017: Oral Oncology
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