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A systematic review of randomised controlled trials with adaptive and traditional group sequential designs – applications in cardiovascular clinical trials
BackgroundTrial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over...
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Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation
BackgroundGroup sequential designs are one of the most widely used methodologies for adaptive design in randomized clinical trials. In settings where...
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Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs
BackgroundAssessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant...
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Multi-arm multi-stage (MAMS) randomised selection designs: impact of treatment selection rules on the operating characteristics
BackgroundMulti-arm multi-stage (MAMS) randomised trial designs have been proposed to evaluate multiple research questions in the confirmatory...
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Adaptive designs in critical care trials: a simulation study
BackgroundAdaptive clinical trials are growing in popularity as they are more flexible, efficient and ethical than traditional fixed designs....
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Comparison of analysis methods and design choices for treatment-by-period interaction in unidirectional switch designs: a simulation study
BackgroundDue to identifiability problems, statistical inference about treatment-by-period interactions has not been discussed for stepped wedge...
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Adaptive designs were primarily used but inadequately reported in early phase drug trials
BackgroundFaced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive...
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The Sequential Therapy in Osteoporosis
BackgroundOsteoporosis management often involves a sequential treatment approach to optimize patient outcomes and minimize fracture risks. This...
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Evaluation by simulation of clinical trial designs for evaluation of treatment during a viral haemorrhagic fever outbreak
BackgroundViral haemorrhagic fevers are characterized by irregular outbreaks with high mortality rate. Difficulties arise when implementing...
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A gated group sequential design for seamless Phase II/III trial with subpopulation selection
BackgroundDue to the high cost and high failure rate of Phase III trials where a classical group sequential design (GSD) is usually used, seamless...
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Randomized and non-randomized designs for causal inference with longitudinal data in rare disorders
In the United States, approximately 7000 rare diseases affect 30 million patients, and only 10% of these diseases have existing therapies. Sound...
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Optimality criteria for futility stop** boundaries for group sequential designs with a continuous endpoint
BackgroundIn clinical trials with fixed study designs, statistical inference is only made when the trial is completed. In contrast, group sequential...
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Randomized test-treatment studies with an outlook on adaptive designs
BackgroundDiagnostic accuracy studies aim to examine the diagnostic accuracy of a new experimental test, but do not address the actual merit of the...
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Leveraging Single-Case Experimental Designs to Promote Personalized Psychological Treatment: Step-by-Step Implementation Protocol with Stakeholder Involvement of an Outpatient Clinic for Personalized Psychotherapy
Our objective is to implement a single-case experimental design (SCED) infrastructure in combination with experience-sampling methods (ESM) into the...
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baymedr: an R package and web application for the calculation of Bayes factors for superiority, equivalence, and non-inferiority designs
BackgroundClinical trials often seek to determine the superiority, equivalence, or non-inferiority of an experimental condition (e.g., a new drug)...
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Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization
BackgroundAdaptive interventions are often used in individualized health care to meet the unique needs of clients. Recently, more researchers have...
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Efficacy of sequential TACE on primary hepatocellular carcinoma with microvascular invasion after radical resection: a systematic review and meta-analysis
ObjectivesThe purpose of this study is to examine the impact of sequential transcatheter arterial chemoembolization (TACE) on the prognosis of...
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A meta-analysis and trial sequential analysis of randomised controlled trials comparing nonoperative and operative management of chest trauma with multiple rib fractures
BackgroundOperative treatment of traumatic rib fractures for better outcomes remains under debate. Surgical stabilization of rib fractures has...
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Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial
BackgroundTreating Helicobacter pylori is becoming increasingly difficult with the development of bacterial resistance to many established treatment...
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Cancer-Net SCa: tailored deep neural network designs for detection of skin cancer from dermoscopy images
BackgroundSkin cancer continues to be the most frequently diagnosed form of cancer in the U.S., with not only significant effects on health and...
