multi-arm clinical trial
A multi stage drop the losers design for multi arm clinical trials
... same trial provides several advantages over doing so in separate ...one multi-arm clinical trial compared to several traditional ...1 Multi-arm multi-stage (MAMS) ...
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Preventing recurrence of endometriosis by means of long acting progestogen therapy (PRE EMPT): report of an internal pilot, multi arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment
... Flexible trial designs have proved beneficial in other trial situations [17, 18], allowing multiple ques- tions to be simultaneously addressed, but often the flexi- bility is provided to accommodate ...
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Uniformly minimum variance conditionally unbiased estimation in multi arm multi stage clinical trials
... Multi-arm multi-stage clinical trials compare several treatments to a common control treatment in a single trial with treatments dropped at interim analyses if, based on observed data, ...
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Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial
... Methods/Design: This article presents the study protocol of a multi-centre two-arm cluster randomised controlled trial (RCT). The research is conducted in Dutch specialised mental health care teams ...
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The R package MAMS for designing multi arm multi stage clinical trials
... In the early stages of drug development there is often uncertainty about the most promising among a set of different treatments, different doses of the same treatment, or combinations of treatments. ...
25
Decision theoretic designs for small trials and pilot studies : a review
... for clinical trials conducted in a single stage so that decisions considered are those taken at the end of the trial and those taken regarding trial design prior to the start of the trial ...
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The World Health Organization ACTION I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: a multi country, multi centre, two arm, parallel, double blind, placebo controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low resource countries
... this trial will use dexa- methasone on account of its wider availability, lower cost, and listing on the WHO Essential Medicines ...The trial regimen is in line with WHO recommendations, namely: 1) a single ...
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Comparison of Bayesian and frequentist group sequential clinical trial designs
... We have focussed on comparison of Bayesian and frequentist group-sequential designs for single-arm and comparative studies. These are just one type of adaptive design, which can include many other features includ- ...
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A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis
... TB trial (controlled comparison of two moxi- floxacin containing treatment shortening regimens in pul- monary tuberculosis) that investigates the effect of two four month regimens against the standard six month ...
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Issues in applying multi arm multi stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial
... The trial addresses this by using a two-part patient information sheet (PIS) where the information about the trial given before randomisation includes only summary information on the individual trial ...
16
Epidemiology and burden of influenza in healthy children aged 6 to 35 months: analysis of data from the placebo arm of a phase III efficacy trial
... placebo-controlled clinical trial con- ducted in several countries in the Northern and Southern Hemispheres examined the efficacy, immunogenicity, and safety of an inactivated quadrivalent influenza vaccine ...
6
A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease
... a multi-centre randomised controlled non-blinded parallel arm ...The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and ...
11
Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols
... This is the first systematic review-based bibliometric analysis of master protocols. The number of master pro- tocols, especially in the last five years, has increased dra- matically and we anticipate that this trend ...
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“I didn’t really understand it, I just thought it’d help”: exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non placebo clinical IMP trial
... non-placebo trial design add the following more specific reasons for in-depth, qualitative investigation of patient perspectives and experiences in this and other similar ...the trial or intervention ...
12
Management of severe COPD exacerbations: focus on beclomethasone dipropionate/formoterol/glycopyrronium bromide
... the trial was mortality rate, which was not met, but at the end of the 3-year follow-up, patients in the combination treatment group had the lowest annual rate ratio of moderate and severe exacerbations ( - 25% vs ...
15
The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial
... Adverse events (AE) are defined as untoward medical in- cidents occurring during the conduct of a research study, which may or may not have a causal relationship with the study procedures [63]. AEs are regarded as ser- ...
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Study protocol for a randomised controlled double-blinded trial of the dose-dependent efficacy and safety of primaquine for clearance of gametocytes in children with uncomplicated falciparum malaria in Uganda
... and how it should be measured. 31 60 The safety pro fi le may best be de fi ned by the incidence of endpoints that could compromise health, such as signs of severe haem- olysis, and the need for interventions such as ...
9
Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial
... controlled trial at three pediatric university dental clinics in Germany: the Charité - Universitätsmedizin Berlin, the Ernst-Moritz-Arndt University Greifswald and the RWTH University of ...
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Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial
... Exploratory univariate analysis and test statistics will be conducted to examine variable distribution. Outliers defined as more than two standard deviations from the mean will be detected. All biomarker variables will ...
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Apatinib treatment combined with chemotherapy for advanced epithelial ovarian cancer: a case report
... Abstract: Apatinib is a novel oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, which has been proved by clinical trials to be effective and safe for patients with ...
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