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A clinical phase I dose-finding design with adaptive shrinking boundaries for drug combination trials
BackgroundCombinations of drugs are becoming increasingly common in oncology treatment. In some cases, patients can benefit from the interaction...
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Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial
PurposeThe early identification of maximum tolerated dose (MTD) in phase I trial leads to faster progression to a phase II trial or an expansion...
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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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An adaptive gBOIN design with shrinkage boundaries for phase I dose-finding trials
BackgroundWith the emergence of molecularly targeted agents and immunotherapies, the landscape of phase I trials in oncology has been changed. Though...
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A dose-finding design for phase I clinical trials based on Bayesian stochastic approximation
BackgroundCurrent dose-finding designs for phase I clinical trials can correctly select the MTD in a range of 30–80% depending on various conditions...
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Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study
BackgroundEarly phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be...
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Protocol: Pentoxifylline optimal dose finding trial in preterm neonates with suspected late onset sepsis (PTX-trial)
BackgroundLate onset sepsis is a leading cause of death and morbidity in preterm infants. Despite optimal antibiotic treatment, sepsis related...
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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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TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis
BackgroundAdaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical...
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A flexible dose-response modeling framework based on continuous toxicity outcomes in phase I cancer clinical trials
BackgroundThe past few decades have seen remarkable developments in dose-finding designs for phase I cancer clinical trials. While many of these...
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Identification of an optimal dose of intravenous ketamine for late-life treatment-resistant depression: a Bayesian adaptive randomization trial
Evidence supporting specific therapies for late-life treatment-resistant depression (LL-TRD) is necessary. This study used Bayesian adaptive...
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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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Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic
BackgroundModern designs for dose-finding studies (e.g., model-based designs such as continual reassessment method) have been shown to substantially...
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Influenza A virus during pregnancy disrupts maternal intestinal immunity and fetal cortical development in a dose- and time-dependent manner
Epidemiological studies link exposure to viral infection during pregnancy, including influenza A virus (IAV) infection, with increased incidence of...
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Strategies for calculating contrast media dose for chest CT
BackgroundTotal body weight (TBW) is a frequently used contrast media (CM) strategy for dose calculation in enhanced CT, yet it is suboptimal as it...
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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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High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial
PurposeThis study aimed at evaluating the efficacy and safety of high-dose (> 0.2 L/kg of treated plasma per day) coupled plasma...
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The efficacy of low-dose CT with deep learning image reconstruction in the surveillance of incidentally detected pancreatic cystic lesions
PurposeTo evaluate the efficacy of low-dose CT (LDCT) with deep learning image reconstruction (DLIR) for the surveillance of pancreatic cystic...
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Machine learning for adaptive deep brain stimulation in Parkinson’s disease: closing the loop
Parkinson’s disease (PD) is the second most common neurodegenerative disease bearing a severe social and economic impact. So far, there is no known...
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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...
