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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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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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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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Improving clinical trials using Bayesian adaptive designs: a breast cancer example
BackgroundTo perform virtual re-executions of a breast cancer clinical trial with a time-to-event outcome to demonstrate what would have happened if...
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Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing
In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials...
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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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The Future Glioblastoma Clinical Trials Landscape: Early Phase 0, Window of Opportunity, and Adaptive Phase I–III Studies
Purpose of ReviewInnovative clinical trial designs for glioblastoma (GBM) are needed to expedite drug discovery. Phase 0, window of opportunity, and...
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Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs
Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical,...
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Optimizing clinical nutrition research: the role of adaptive and pragmatic trials
Evidence-based nutritional recommendations address the health impact of suboptimal nutritional status. Efficacy randomized controlled trials (RCTs)...
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Evaluation of two-stage designs of Phase 2 single-arm trials in glioblastoma: a systematic review
BackgroundDue to economical and ethical reasons, the two-stage designs have been widely used for Phase 2 single-arm trials in oncology because the...
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Patient and public involvement and engagement in the development of innovative patient-centric early phase dose-finding trial designs
BackgroundIn light of the FDA’s Project Optimus initiative, there is fresh interest in leveraging Patient-reported Outcome (PRO) data to enhance the...
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A novel Bayesian adaptive design incorporating both primary and secondary endpoints for randomized IIB chemoprevention study of women at increased risk for breast cancer
BackgroundOur randomized controlled clinical trial will explore the potential of bazedoxifene plus conjugated estrogen to modulate breast...
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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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Practical guidance for planning resources required to support publicly-funded adaptive clinical trials
Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent...
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Bayesian adaptive design for pediatric clinical trials incorporating a community of prior beliefs
BackgroundPediatric population presents several barriers for clinical trial design and analysis, including ethical constraints on the sample size and...
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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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Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project
BackgroundAdaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further...
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A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial
The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is a multifactorial Bayesian adaptive platform trial that aims to improve the way...
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Interventional Study Designs
Interventional studies are specifically designed to evaluate direct impact of therapeutic or preventive measures on outcomes by assigning...