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Clinical trial simulation

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https://www.readbyqxmd.com/read/28734644/postmastectomy-radiation-therapy-technique-and-cardiopulmonary-sparing-a-dosimetric-comparative-analysis-between-photons-and-protons-with-free-breathing-versus-deep-inspiration-breath-hold
#1
Sagar A Patel, Hsiao-Ming Lu, Jacqueline A Nyamwanda, Rachel B Jimenez, Alphonse G Taghian, Shannon M MacDonald, Nicolas Depauw
PURPOSE: Dosimetric studies have suggested greater cardiopulmonary sparing with protons over photons for left-sided postmastectomy radiation therapy (PMRT). Modern techniques such as deep inspiration breath hold (DIBH) can help spare the heart. This analysis compares photon and proton delivery with and without DIBH. METHODS AND MATERIALS: Ten women with left breast cancer referred for PMRT on a prospective clinical trial with unfavorable cardiac anatomy underwent free breathing (FB) and DIBH computed tomography simulation...
June 21, 2017: Practical Radiation Oncology
https://www.readbyqxmd.com/read/28732525/effectiveness-and-cost-effectiveness-of-embedded-simulation-in-occupational-therapy-clinical-practice-education-study-protocol-for-a-randomised-controlled-trial
#2
Christine Imms, Eli Mang Yee Chu, Stephen Guinea, Loretta Sheppard, Elspeth Froude, Rob Carter, Susan Darzins, Samantha Ashby, Susan Gilbert-Hunt, Nigel Gribble, Kelli Nicola-Richmond, Merrolee Penman, Elena Gospodarevskaya, Erin Mathieu, Mark Symmons
BACKGROUND: Clinical placements are a critical component of the training for health professionals such as occupational therapists. However, with growing student enrolments in professional education courses and workload pressures on practitioners, it is increasingly difficult to find sufficient, suitable placements that satisfy program accreditation requirements. The professional accrediting body for occupational therapy in Australia allows up to 200 of the mandatory 1000 clinical placement hours to be completed via simulation activities, but evidence of effectiveness and efficiency for student learning outcomes is lacking...
July 21, 2017: Trials
https://www.readbyqxmd.com/read/28728594/implementing-the-efftox-dose-finding-design-in-the-matchpoint-trial
#3
Kristian Brock, Lucinda Billingham, Mhairi Copland, Shamyla Siddique, Mirjana Sirovica, Christina Yap
BACKGROUND: The Matchpoint trial aims to identify the optimal dose of ponatinib to give with conventional chemotherapy consisting of fludarabine, cytarabine and idarubicin to chronic myeloid leukaemia patients in blastic transformation phase. The dose should be both tolerable and efficacious. This paper describes our experience implementing EffTox in the Matchpoint trial. METHODS: EffTox is a Bayesian adaptive dose-finding trial design that jointly scrutinises binary efficacy and toxicity outcomes...
July 20, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28728559/effect-of-insulin-therapy-and-dietary-adjustments-on-safety-and-performance-during-simulated-soccer-tests-in-people-with-type-1-diabetes-study-protocol-for-a-randomized-controlled-trial
#4
Javier Calvo-Marín, Gabriel Torrealba-Acosta, Matthew Campbell, Jesse Gaboury, Ajmol Ali, Chih Hao Chen-Ku
BACKGROUND: Despite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for its effectiveness with intermittent forms of exercise, such as soccer, is still lacking. METHODS/DESIGN: We designed a study protocol for a randomized, crossover, double-blinded, controlled trial, for the evaluation of the effect that a strategy of dietary and therapeutic modifications may have on safety and performance of persons with T1D in soccer training sessions and cognitive testing...
July 20, 2017: Trials
https://www.readbyqxmd.com/read/28725482/systems-biology-driving-drug-development-from-design-to-the-clinical-testing-of-the-anti-erbb3-antibody-seribantumab-mm-121
#5
REVIEW
Birgit Schoeberl, Art Kudla, Kristina Masson, Ashish Kalra, Michael Curley, Gregory Finn, Emily Pace, Brian Harms, Jaeyeon Kim, Jeff Kearns, Aaron Fulgham, Olga Burenkova, Viara Grantcharova, Defne Yarar, Violette Paragas, Jonathan Fitzgerald, Marisa Wainszelbaum, Kip West, Sara Mathews, Rachel Nering, Bambang Adiwijaya, Gabriela Garcia, Bill Kubasek, Victor Moyo, Akos Czibere, Ulrik B Nielsen, Gavin MacBeath
The ErbB family of receptor tyrosine kinases comprises four members: epidermal growth factor receptor (EGFR/ErbB1), human EGFR 2 (HER2/ErbB2), ErbB3/HER3, and ErbB4/HER4. The first two members of this family, EGFR and HER2, have been implicated in tumorigenesis and cancer progression for several decades, and numerous drugs have now been approved that target these two proteins. Less attention, however, has been paid to the role of this family in mediating cancer cell survival and drug tolerance. To better understand the complex signal transduction network triggered by the ErbB receptor family, we built a computational model that quantitatively captures the dynamics of ErbB signaling...
2017: NPJ Systems Biology and Applications
https://www.readbyqxmd.com/read/28723910/estimating-mono-and-bi-phasic-regression-parameters-using-a-mixture-piecewise-linear-bayesian-hierarchical-model
#6
Rui Zhao, Paul Catalano, Victor G DeGruttola, Franziska Michor
The dynamics of tumor burden, secreted proteins or other biomarkers over time, is often used to evaluate the effectiveness of therapy and to predict outcomes for patients. Many methods have been proposed to investigate longitudinal trends to better characterize patients and to understand disease progression. However, most approaches assume a homogeneous patient population and a uniform response trajectory over time and across patients. Here, we present a mixture piecewise linear Bayesian hierarchical model, which takes into account both population heterogeneity and nonlinear relationships between biomarkers and time...
2017: PloS One
https://www.readbyqxmd.com/read/28723718/three-dimensional-head-mounted-gaming-task-procedure-maximizes-effects-of-vestibular-rehabilitation-in-unilateral-vestibular-hypofunction-a-randomized-controlled-pilot-trial
#7
Alessandro Micarelli, Andrea Viziano, Ivan Augimeri, Domenico Micarelli, Marco Alessandrini
Considering the emerging advantages related to virtual reality implementation in clinical rehabilitation, the aim of the present study was to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing only vestibular rehabilitation and (ii) HMD procedure-related side effects. Therefore, 24 vestibular rehabilitation and 23-matched HMD unilateral vestibular hypofunction individuals simultaneously underwent a 4-week rehabilitation protocol...
July 18, 2017: International Journal of Rehabilitation Research. Revue Internationale de Recherches de Réadaptation
https://www.readbyqxmd.com/read/28722322/advanced-methods-for-dose-and-regimen-finding-during-drug-development-summary-of-the-ema-efpia-workshop-on-dose-finding-london-4-5-december-2014
#8
F T Musuamba, E Manolis, N Holford, Sya Cheung, L E Friberg, K Ogungbenro, M Posch, Jwt Yates, S Berry, N Thomas, S Corriol-Rohou, B Bornkamp, F Bretz, A C Hooker, P H Van der Graaf, J F Standing, J Hay, S Cole, V Gigante, K Karlsson, T Dumortier, N Benda, F Serone, S Das, A Brochot, F Ehmann, R Hemmings, I Skottheim Rusten
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014)...
July 19, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28721105/prediction-of-efficacy-for-conversion-from-adjunctive-therapy-to-monotherapy-with-eslicarbazepine-acetate-800-mg-once-daily-for-partial-onset-epilepsy
#9
Soujanya Sunkaraneni, Julie A Passarell, Elizabeth A Ludwig, Jill Fiedler-Kelly, Janet K Pitner, Todd A Grinnell, David Blum
PURPOSE: Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). Clinical studies of gradual conversion to ESL 1,200 and 1,600 mg QD monotherapies were previously conducted in patients with POS who were not well-controlled by 1 or 2 AEDs. This report describes modeling and simulation of plasma eslicarbazepine (primary active metabolite of ESL) concentrations and time to monotherapy study exit to predict efficacy for conversion to ESL monotherapy at a lower dose of 800 mg, as an option for patients requiring or not tolerating higher doses since this regimen is effective in adjunctive therapy for POS...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28720322/rodent-large-animal-and-non-human-primate-models-of-spinal-cord-injury
#10
REVIEW
Raffaele Nardone, Cristina Florea, Yvonne Höller, Francesco Brigo, Viviana Versace, Piergiorgio Lochner, Stefan Golaszewski, Eugen Trinka
In this narrative review we aimed to assess the usefulness of the different animal models in identifying injury mechanisms and developing therapies for humans suffering from spinal cord injury (SCI). Results obtained from rodent studies are useful but, due to the anatomical, molecular and functional differences, confirmation of these findings in large animals or non-human primates may lead to basic discoveries that cannot be made in rodent models and that are more useful for developing treatment strategies in humans...
June 21, 2017: Zoology: Analysis of Complex Systems, ZACS
https://www.readbyqxmd.com/read/28720054/impact-of-novel-agents-on-patient-relevant-outcomes-in-patients-with-previously-untreated-cll-who-are-not-eligible-for-fludarabine-based-therapy
#11
Moushmi Singh, Stuart Mealing, Simona Baculea, Sarah Cote, Jo Whelan
BACKGROUND: Chronic lymphocytic leukemia (CLL) is an orphan disease that primarily affects the elderly. The majority of symptomatic patients eligible for frontline treatment are unfit for fludarabine based chemoimmunotherapy. Historical treatment includes chlorambucil (Chl), bendamustine/rituximab (BR), and chlorambucil/rituximab/ChlR combination. Clinical guidelines now recommend the use of novel agents, such as ibrutinib (Ibr), in both frontline and relapse settings and other novel agents, such as idelalisib (with rituximab), in relapse settings...
July 19, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28717987/interventions-for-refractory-trigeminal-neuralgia-a-bayesian-mixed-treatment-comparison-network-meta-analysis-of-randomized-controlled-clinical-trials
#12
Kannan Sridharan, Gowri Sivaramakrishnan
INTRODUCTION: Patients with trigeminal neuralgia (TN) are often refractory to recommended first-line agents. Due to the absence of a systematic review, we undertook a network meta-analysis to assess various interventions that can be used to manage refractory TN. METHODS: Electronic databases were searched using appropriate strategies to identify randomized controlled clinical trials in patients with refractory TN, evaluating the proportion of patients with a minimum of 50% reduction in pain or a minimum of 2 cm reduction in score in an appropriate pain scale or complete pain relief by subjective pain scales...
July 17, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28716797/a-pragmatic-phase-iii-multisite-double-blind-placebo-controlled-parallel-arm-dose-increment-randomised-trial-of-regular-low-dose-extended-release-morphine-for-chronic-breathlessness-breathlessness-exertion-and-morphine-sulfate-beams-study-protocol
#13
David Currow, Gareth John Watts, Miriam Johnson, Christine F McDonald, John O Miners, Andrew A Somogyi, Linda Denehy, Nicola McCaffrey, Danny J Eckert, Philip McCloud, Sandra Louw, Lawrence Lam, Aine Greene, Belinda Fazekas, Katherine C Clark, Kwun Fong, Meera R Agar, Rohit Joshi, Sharon Kilbreath, Diana Ferreira, Magnus Ekström
INTRODUCTION: Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD...
July 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28715911/hepatitis-c-treatment-regimens-are-cost-effective-but-compared-with-what
#14
T Joseph Mattingly, Julia F Slejko, C Daniel Mullins
BACKGROUND: Numerous economic models have been published evaluating treatment of chronic hepatitis C virus (HCV) infection, but none provide a comprehensive comparison among new antiviral agents. OBJECTIVE: Evaluate the cost-effectiveness of all recommended therapies for treatment of genotypes 1 and 4 chronic HCV. METHODS: Using data from clinical trials, observational analyses, and drug pricing databases, Markov decision models were developed for HCV genotypes 1 and 4 to compare all recommended drugs from the perspective of the third-party payer over a 5-, 10-, and 50-year time horizon...
July 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28712629/the-prime-diabetes-model-novel-methods-for-estimating-long-term-clinical-and-cost-outcomes-in-type-1-diabetes-mellitus
#15
William J Valentine, Richard F Pollock, Rhodri Saunders, Jay Bae, Kirsi Norrbacka, Kristina Boye
BACKGROUND: Recent publications describing long-term follow-up from landmark trials and diabetes registries represent an opportunity to revisit modeling options in type 1 diabetes mellitus (T1DM). OBJECTIVES: To develop a new product-independent model capable of predicting long-term clinical and cost outcomes. METHODS: After a systematic literature review to identify clinical trial and registry data, a model was developed (the PRIME Diabetes Model) to simulate T1DM progression and complication onset...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28710902/a-brief-psychological-intervention-for-mothers-of-children-with-food-allergy-can-change-risk-perception-and-reduce-anxiety-outcomes-of-a-randomised-controlled-trial
#16
Robert J Boyle, Thisanayagam Umasunthar, Jared G Smith, Heather Hanna, Annabella Procktor, Katherine Phillips, Camila Pinto, Claudia Gore, Helen E Cox, John O Warner, Bea Vickers, Matthew Hodes
BACKGROUND: Mothers of children with food allergy have increased anxiety, which may be influenced by healthcare professionals' communication of risk. OBJECTIVE: To evaluate a brief psychological intervention for reducing anxiety in mothers of children with food allergy. METHODS: Two hundred mothers of children with food allergy were recruited from allergy clinics. A computer-generated randomization list was used to allocate participants to a single-session Cognitive Behavioural Therapy intervention including a risk communication module, or standard care...
July 15, 2017: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28710715/clinical-utility-of-a-blood-based-protein-assay-to-increase-screening-of-elevated-risk-patients-for-colorectal-cancer-in-the-primary-care-setting
#17
John Peabody, David Paculdo, Eric Swagel, Steven Fugaro, Mary Tran
PURPOSE: Colorectal cancer (CRC) screening is effective in finding early stage CRC and dramatically improves survival rates. Despite this, the number of eligible patients who do not obtain CRC screening is unacceptably high. METHODS: We conducted a longitudinal, randomized controlled trial investigating the utility of a blood-based protein assay on the quality of care delivered by practicing PCPs in the United States. We used standardized simulated patients (CPVs), presenting with symptoms suggestive of a higher likelihood of CRC, to measure how frequently these PCPs ordered diagnostic colonoscopy...
July 14, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28709989/evaluating-biapenem-dosage-regimens-in-intensive-care-unit-patients-with-pseudomonas-aeruginosa-infections-a-pharmacokinetic-pharmacodynamic-analysis-using-monte-carlo-simulation
#18
Yongfu Hang, Yafang Chen, Ling Xue, Shusen Sun, Long Liu, Jie Gao, Cheng Xie, Xianfeng Zhang, Jianguo Zhu, Jun Jin, Liyan Miao
This study sought to both identify optimal dosage regimens and estimate pharmacokinetic/pharmacodynamics characteristics of short-infusion (SI) versus extended-infusion (EI) for the use of biapenem against Pseudomonas aeruginosa infections in Chinese Intensive Care patients. A total of 85 strains of P. aeruginosa were collected, and the minimum inhibitory concentration (MIC) of biapenem was measured by the serial two-fold agar dilution method. We designed four frequently used clinical regimens: biapenem 300mg I...
July 11, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28706157/a-bayesian-pick-the-winner-design-in-a-randomized-phase-ii-clinical-trial
#19
Dung-Tsa Chen, Po-Yu Huang, Hui-Yi Lin, Alberto A Chiappori, Dmitry I Gabrilovich, Eric B Haura, Scott J Antonia, Jhanelle E Gray
PURPOSE: Many phase II clinical trials evaluate unique experimental drugs/combinations through multi-arm design to expedite the screening process (early termination of ineffective drugs) and to identify the most effective drug (pick the winner) to warrant a phase III trial. Various statistical approaches have been developed for the pick-the-winner design but have been criticized for lack of objective comparison among the drug agents. METHODS: We developed a Bayesian pick-the-winner design by integrating a Bayesian posterior probability with Simon two-stage design in a randomized two-arm clinical trial...
July 7, 2017: Oncotarget
https://www.readbyqxmd.com/read/28705082/projected-improvements-in-accelerated-partial-breast-irradiation-using-a-novel-breast-stereotactic-radiotherapy-device-a-dosimetric-analysis
#20
James W Snider, Yildirim Mutaf, Elizabeth Nichols, Andrea Hall, Patrick Vadnais, William F Regine, Steven J Feigenberg
Accelerated partial breast irradiation has caused higher than expected rates of poor cosmesis. At our institution, a novel breast stereotactic radiotherapy device has demonstrated dosimetric distributions similar to those in brachytherapy. This study analyzed comparative dose distributions achieved with the device and intensity-modulated radiation therapy accelerated partial breast irradiation. Nine patients underwent computed tomography simulation in the prone position using device-specific immobilization on an institutional review board-approved protocol...
January 1, 2017: Technology in Cancer Research & Treatment
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