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Adaptive trial design

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https://www.readbyqxmd.com/read/29039265/hiv-prevention-trial-design-in-an-era-of-effective-pre-exposure-prophylaxis
#1
Amy Cutrell, Deborah Donnell, David T Dunn, David V Glidden, Anneke Grobler, Brett Hanscom, Britt S Stancil, R Daniel Meyer, Ronnie Wang, Robert L Cuffe
Pre-exposure prophylaxis (PrEP) has demonstrated remarkable effectiveness protecting at-risk individuals from HIV-1 infection. Despite this record of effectiveness, concerns persist about the diminished protective effect observed in women compared with men and the influence of adherence and risk behaviors on effectiveness in targeted subpopulations. Furthermore, the high prophylactic efficacy of the first PrEP agent, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), presents challenges for demonstrating the efficacy of new candidates...
October 17, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29036330/adding-experimental-arms-to-platform-clinical-trials-randomization-procedures-and-interim-analyses
#2
Steffen Ventz, Matteo Cellamare, Giovanni Parmigiani, Lorenzo Trippa
Multi-arm clinical trials use a single control arm to evaluate multiple experimental treatments. In most cases this feature makes multi-arm studies considerably more efficient than two-arm studies. A bottleneck for implementation of a multi-arm trial is the requirement that all experimental treatments have to be available at the enrollment of the first patient. New drugs are rarely at the same stage of development. These limitations motivate our study of statistical methods for adding new experimental arms after a clinical trial has started enrolling patients...
July 17, 2017: Biostatistics
https://www.readbyqxmd.com/read/29030654/predictive-and-prognostic-value-of-tumor-volume-and-its-changes-during-radical-radiotherapy-of-stage%C3%A2-iii-non-small-cell-lung-cancer-a%C3%A2-systematic-review
#3
Lukas Käsmann, Maximilian Niyazi, Oliver Blanck, Christian Baues, René Baumann, Sophie Dobiasch, Chukwuka Eze, Daniel Fleischmann, Tobias Gauer, Frank A Giordano, Yvonne Goy, Jan Hausmann, Christoph Henkenberens, David Kaul, Lisa Klook, David Krug, Matthias Mäurer, Cédric M Panje, Johannes Rosenbrock, Lisa Sautter, Daniela Schmitt, Christoph Süß, Alexander H Thieme, Maike Trommer-Nestler, Sonia Ziegler, Nadja Ebert, Daniel Medenwald, Christian Ostheimer
PURPOSE: Lung cancer remains the leading cause of cancer-related mortality worldwide. Stage III non-small cell lung cancer (NSCLC) includes heterogeneous presentation of the disease including lymph node involvement and large tumour volumes with infiltration of the mediastinum, heart or spine. In the treatment of stage III NSCLC an interdisciplinary approach including radiotherapy is considered standard of care with acceptable toxicity and improved clinical outcome concerning local control...
October 13, 2017: Strahlentherapie und Onkologie: Organ der Deutschen Röntgengesellschaft ... [et Al]
https://www.readbyqxmd.com/read/29028418/cancer-center-clinic-and-research-team-perceptions-of-identity-and-interactions
#4
Torsten Reimer, Simon J Craddock Lee, Sandra Garcia, Mary Gill, Tobi Duncan, Erin L Williams, David E Gerber
PURPOSE: Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members' perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. METHODS: We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias...
October 13, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/29021945/an-evaluation-of-instructive-feedback-to-teach-play-behavior-to-a-child-with-autism-spectrum-disorder
#5
Laura L Grow, Tiffany Kodak, Andrea Clements
Instructive feedback is used to expose learners to secondary targets during skill acquisition programs (Reichow & Wolery, in Journal of Applied Behavior Analysis, 44, 327-340, 2011; Werts, Wolery, Gast, & Holcombe, in Journal of Behavioral Education, 5, 55-75, 1995). Although unrelated feedback may have clinical utility in practice, very little research has evaluated unrelated instructive feedback, particularly for promoting play behavior (Colozzi, Ward, & Crotty, in Education and Training in Developmental Disabilities, 43, 226-248, 2008)...
September 2017: Behavior Analysis in Practice
https://www.readbyqxmd.com/read/29017690/the-range-and-scientific-value-of-randomized-trials
#6
Stefan Lange, Stefan Sauerland, Jörg Lauterberg, Jürgen Windeler
BACKGROUND: The randomized, controlled trial (RCT) is the gold standard of scientific evidence for the attribution of clinical effects (benefits and harms) to medical interventions. Many different designs for RCTs have been developed in order to counter legitimate critical objections and to better adapt the trials to the continually changing challenges that face clinical research. METHODS: The diversity and adaptability of randomized trial designs are presented and discussed on the basis of a selective literature review and specific illustrative examples...
September 22, 2017: Deutsches Ärzteblatt International
https://www.readbyqxmd.com/read/29016865/inability-of-positive-phase-ii-clinical-trials-of-investigational-treatments-to-subsequently-predict-positive-phase-iii-clinical-trials-in-glioblastoma
#7
Jacob J Mandel, Shlomit Yust-Katz, Akash J Patel, David Cachia, Diane Liu, Minjeong Park, Ying Yuan, Thomas A Kent, John F de Groot
Background: Glioblastoma is the most common primary malignant brain tumor in adults, but effective therapies are lacking. With the scarcity of positive phase III trials, which are increasing in cost, we examined the ability of positive phase II trials to predict statistically significant improvement in clinical outcomes of phase III trials. Methods: A PubMed search was conducted to identify phase III clinical trials performed in the past 25 years for patients with newly diagnosed or recurrent glioblastoma...
July 31, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/28993313/checkpoint-inhibitors-spur-changes-in-trial-design
#8
(no author information available yet)
Given the success of checkpoint inhibitors and the desire to test them in combination with other immunotherapies and targeted therapies, hundreds of clinical trials have been launched. To most efficiently study these agents, researchers and the FDA are exploring the use of novel endpoints, the use of new preclinical models, and adaptive trial designs. However, the cost and demands associated with the conduct of increasingly sophisticated early-phase clinical trials are putting smaller companies and some academic medical centers at a disadvantage...
October 9, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28992168/pulmonary-hypertension-related-to-systemic-sclerosis-points-to-consider-for-clinical-trials
#9
REVIEW
Marc Humbert, Manjit Singh, Daniel E Furst, Dinesh Khanna, James R Seibold
There are proven successful approaches to clinical trial design in pulmonary arterial hypertension (PAH), which in turn have led to the licensing of a number of effective therapies. SSc has been included in trials of World Health Organization Group 1 PAH but has been under-represented. Responses in outcomes as diverse as exercise capacity, quality of life, durability of drug effect and survival have been reduced in comparison with those seen in idiopathic PAH. The PAH community has achieved international and interdisciplinary consensus guidelines for future studies...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28991832/adaptation-of-a-biomarker-based-sepsis-mortality-risk-stratification-tool-for-pediatric-acute-respiratory-distress-syndrome
#10
Nadir Yehya, Hector R Wong
OBJECTIVES: The original Pediatric Sepsis Biomarker Risk Model and revised (Pediatric Sepsis Biomarker Risk Model-II) biomarker-based risk prediction models have demonstrated utility for estimating baseline 28-day mortality risk in pediatric sepsis. Given the paucity of prediction tools in pediatric acute respiratory distress syndrome, and given the overlapping pathophysiology between sepsis and acute respiratory distress syndrome, we tested the utility of Pediatric Sepsis Biomarker Risk Model and Pediatric Sepsis Biomarker Risk Model-II for mortality prediction in a cohort of pediatric acute respiratory distress syndrome, with an a priori plan to revise the model if these existing models performed poorly...
October 6, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28988992/limb-leaf-designs-for-adaptive-exploration-of-the-dose-response-curve
#11
John Spivack, Bin Cheng, Bruce Levin
We propose a two-stage strategy, called the Limb-Leaf method, to explore the dose-response curve using dose promotion and addition in the context of adaptive seamless Phase II/III trials. Strong control of the overall type 1 familywise error rate of the proposed method is enforced by the closed testing principle. The design constants are determined to minimize the risk-adjusted expected total sample size while maintaining a target power. In the case of a nonmonotonic dose response curve where more doses are required to adequately explore the curve, substantial savings in sample size are achieved compared with a traditional strategy which offers only selection and promotion from among initial first stage doses...
October 6, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28987591/a-dynamic-model-to-simulate-potassium-balance-in-dairy-cows
#12
M Berg, J Plöntzke, S Leonhard-Marek, K E Müller, S Röblitz
High-performing dairy cows require a particular composition of nutritional ingredients, adapted to their individual requirements and depending on their production status. The optimal dimensioning of minerals in the diet, one being potassium, is indispensable for the prevention of imbalances. Potassium balance in cows is the result of potassium intake, distribution in the organism, and excretion, and it is closely related to glucose and electrolyte metabolism. In this paper, we present a dynamical model for potassium balance in lactating and nonlactating dairy cows based on ordinary differential equations...
October 4, 2017: Journal of Dairy Science
https://www.readbyqxmd.com/read/28982263/a-simulation-study-of-outcome-adaptive-randomization-in-multi-arm-clinical-trials
#13
J Kyle Wathen, Peter F Thall
Randomizing patients among treatments with equal probabilities in clinical trials is the established method to obtain unbiased comparisons. In recent years, motivated by ethical considerations, many authors have proposed outcome adaptive randomization, wherein the randomization probabilities are unbalanced, based on interim data, to favor treatment arms having more favorable outcomes. While there has been substantial controversy regarding the merits and flaws of adaptive versus equal randomization, there has not yet been a systematic simulation study in the multi-arm setting...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28982262/adaptive-designs-the-swiss-army-knife-among-clinical-trial-designs
#14
Frank Bretz, Paul Gallo, Willi Maurer
There has been considerable progress in the development and implementation of adaptive designs over the past 30 years. A major driver for this class of novel designs is the possibility to increase the information value of clinical trial data to enable better decisions, leading to more efficient drug development processes and improved late-stage success rates. In the first part of this article, we review the development of adaptive designs from different perspectives. We trace back key historical papers, report on landmark adaptive design clinical trials, review major cross-industry collaborations, and highlight key regulatory guidance documents...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28980435/a-bayesian-sequential-design-with-adaptive-randomization-for-2-sided-hypothesis-test
#15
Qingzhao Yu, Lin Zhu, Han Zhu
Bayesian sequential and adaptive randomization designs are gaining popularity in clinical trials thanks to their potentials to reduce the number of required participants and save resources. We propose a Bayesian sequential design with adaptive randomization rates so as to more efficiently attribute newly recruited patients to different treatment arms. In this paper, we consider 2-arm clinical trials. Patients are allocated to the 2 arms with a randomization rate to achieve minimum variance for the test statistic...
October 4, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28973741/performance-of-grain-sorghum-hybrids-under-drought-stress-using-gge-biplot-analyses
#16
P S C Batista, C B Menezes, A J Carvalho, A F Portugal, E A Bastos, M J Cardoso, C V Santos, M P M Julio
The objective of this study was to estimate the adaptability and stability of grain sorghum hybrids grown under post-flowering water stress and non-stress conditions. The trials were carried out in Nova Porteirinha-MG during the season of 2014 and 2015, and in Teresina-PI in the 2014 season. Twenty-nine-grain sorghum hybrids were evaluated, in a randomized complete block design, with three replications. Plots consisted of four lines with 3 m long. The grain yield data were submitted to the individual variance analysis, having considered the effects of the hybrids as fixed and the other effects as random...
September 21, 2017: Genetics and Molecular Research: GMR
https://www.readbyqxmd.com/read/28971312/the-transition-into-young-adulthood-a-critical-period-for-weight-control
#17
REVIEW
Autumn Lanoye, Kristal L Brown, Jessica G LaRose
PURPOSE OF REVIEW: Emerging adulthood (age 18-25) represents a critical period for weight control: rate of weight gain is greatest during these years and the prevalence of overweight and obesity is estimated to be at least 40% among emerging adults. Unique behavioral, psychosocial, and cognitive risk factors among this population must be specifically addressed within weight management programs. We review extant treatment approaches, including lessons learned from the nascent literature specifically targeting this population...
October 2, 2017: Current Diabetes Reports
https://www.readbyqxmd.com/read/28971281/model-informed-pediatric-development-applied-to-bilastine-ontogenic-pk-model-development-dose-selection-for-first-time-in-children-and-pk-study-design
#18
Valvanera Vozmediano, Ander Sologuren, John C Lukas, Nerea Leal, Mónica Rodriguez
PURPOSE: Bilastine is an H1 antagonist whose pharmacokinetics (PK) and pharmacodynamics (PD) have been resolved in adults with a therapeutic oral dose of 20 mg/day. Bilastine has favorable characteristics for use in pediatrics but the PK/PD and the optimal dose in children had yet to be clinically explored. The purpose is to: (1) Develop an ontogenic predictive model of bilastine PK linked to the PD in adults by integrating current knowledge; (2) Use the model to design a PK study in children; (3) Confirm the selected dose and the study design through the evaluation of model predictability in the first recruited children; (4) Consider for inclusion the group of younger children (< 6 years)...
October 2, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28969702/crowdsourcing-to-promote-hiv-testing-among-msm-in-china-study-protocol-for-a-stepped-wedge-randomized-controlled-trial
#19
Joseph D Tucker
BACKGROUND: HIV testing for marginalized populations is critical to controlling the HIV epidemic. However, the HIV testing rate among men who have sex with men (MSM) in China remains low. Crowdsourcing, the process of shifting individual tasks to a group, has been increasingly adopted in public health programs and may be a useful tool for spurring innovation in HIV testing campaigns. We designed a multi-site study to develop a crowdsourced HIV test promotion campaign and evaluate its effectiveness against conventional campaigns among MSM in China...
October 2, 2017: Trials
https://www.readbyqxmd.com/read/28969588/design-considerations-and-analysis-planning-of-a-phase-2a-proof-of-concept-study-in-rheumatoid-arthritis-in-the-presence-of-possible-non-monotonicity
#20
Feng Liu, Stephen J Walters, Steven A Julious
BACKGROUND: It is important to quantify the dose response for a drug in phase 2a clinical trials so the optimal doses can then be selected for subsequent late phase trials. In a phase 2a clinical trial of new lead drug being developed for the treatment of rheumatoid arthritis (RA), a U-shaped dose response curve was observed. In the light of this result further research was undertaken to design an efficient phase 2a proof of concept (PoC) trial for a follow-on compound using the lessons learnt from the lead compound...
October 2, 2017: BMC Medical Research Methodology
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