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Abstract: Background: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional...

RESEARCH ARTICLE adaptive designs Adaptive clinical trials Clinical Trials Efficiency Resource requirements Trial coordination

One family of designs that can noticeably improve efficiency in later stages of drug development are multi-arm multi-stage (MAMS) designs. They allow several arms to be studied concurrently and gain efficiency by dropping poorly...

adaptive designs Infectious Diseases Multi-arm multi-stage order restriction Clinical Trials as Topic Humans Research Design Sample Size

adaptive designs CARA randomization ethics multi-armed bandit Sequential allocation Clinical Trials as Topic Humans Models Statistical Random Allocation therapeutics Treatment Failure

INTRODUCTION: The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the...

adaptive designs Continual reassessment method dose escalation Dose-finding Maximum Tolerated Dose phase I trials Clinical Trials Phase I as Topic Computer Simulation Dose-Response Relationship Drug Humans Maximum Tolerated Dose Research Design

adaptive designs Bayesian methods Clinical Trials dose escalation Model-free Time-to-event

Bayesian methods adaptive designs dose-toxicity modelling Drug Combinations phase I trials Algorithms Antineoplastic Agents Antineoplastic Combined Chemotherapy Protocols Biostatistics Clinical Trials Phase I as Topic Cohort Studies Computer Simulation Dose-Response Relationship Drug Drug Administration Schedule Humans Interatrial Block Models Statistical Neoplasms

We propose a novel response-adaptive randomization procedure for multi-armed trials with continuous outcomes that are assumed to be normally distributed. Our proposed rule is non-myopic, and oriented toward a patient benefit...

Gittins index adaptive designs continuous endpoint dichotomization missing data unknown variance Adaptive Clinical Trials as Topic Algorithms Biometry Clinical Trials Phase II as Topic Computer Simulation Endpoint Determination Humans Models Statistical Neoplasms Patient Dropouts Randomized Controlled Trials as Topic Treatment Outcome

BACKGROUND: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resources are...

Adaptive clinical trials adaptive designs Clinical Trials Efficiency Resource requirements Trial coordination Cost-Benefit Analysis Humans Research Design Research Personnel Workforce

Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations where they have...

Efficiency Clinical Trials adaptive designs Adaptive clinical trials Resource requirements Trial coordination Humans Research Design

BACKGROUND: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resources are...

Adaptive clinical trials adaptive designs Clinical Trials Efficiency Resource requirements Trial coordination Cost-Benefit Analysis Humans Research Design Research Personnel Workforce