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A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials
A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials
Dr. Bernard Fisher (1918-2019) was an early proponent of evidence-based medicine using the mechanism of prospective, multi...
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States
BackgroundIndigenous peoples are overrepresented with chronic health conditions and experience suboptimal outcomes compare...
Protecting blinded trials in electronic hospital systems
Protecting blinded trials in electronic hospital systems
Access to society journal content varies across our titles. If you have access to a journal via a society or association ...
Influential methods reports for group-randomized trials and related designs
Influential methods reports for group-randomized trials and related designs
Background. This article identifies the most influential methods reports for group-randomized trials and related designs p...
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model
Background/aimsThis work is motivated by the HEALing Communities Study, which is a post-test only cluster randomized trial...
A survey of patients with laryngotracheal stenosis on future clinical trial design
A survey of patients with laryngotracheal stenosis on future clinical trial design
Background/AimsLaryngotracheal stenosis is a rare but devastating proximal airway fibrosis that restricts a patient’s abil...
Time trends with response-adaptive randomization: The inevitability of inefficiency
Time trends with response-adaptive randomization: The inevitability of inefficiency
Response-adaptive randomization, which changes the randomization ratio as a randomized clinical trial progresses, is ineff...
Contrasting approaches for addressing non-adherence in randomized controlled trials: An illustration from the REFLUX trial
Contrasting approaches for addressing non-adherence in randomized controlled trials: An illustration from the REFLUX trial
Background:In many randomized controlled trials, a substantial proportion of patients do not comply with the treatment pro...
Clarifying selection bias in cluster randomized trials
Clarifying selection bias in cluster randomized trials
BackgroundIn cluster randomized trials, patients are typically recruited after clusters are randomized, and the recruiters...
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm
Background/AimsGeneralized estimating equations are commonly used to fit logistic regression models to clustered binary da...
Design of a novel clinical trial of prehospital pediatric airway management
Design of a novel clinical trial of prehospital pediatric airway management
Emergency Medical Services personnel are often the first to intervene in the care of critically ill children. Airway manag...
Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention
Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention
BackgroundEnsuring protocol visit compliance and maintaining high participant retention remain critical elements of clinic...
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement
Background and AimsWe need more pragmatic trials of interventions to improve care and outcomes for people living with Alzh...
Abstracts from the SCT 42nd annual meeting (2021)
Abstracts from the SCT 42nd annual meeting (2021)
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Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations
Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, th...
Clinical Trials to authors: Please pre-register your studies!
Clinical Trials to authors: Please pre-register your studies!
1. The World Medical Association (WMA) . WMA Declaration of Helsinki—ethical principles for medical research involving hum...
Can quality management drive evidence generation?
Can quality management drive evidence generation?
Recent guidance documents from international regulators emphasize the importance of thoughtful trial design and risk-based...
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens
The use of the controlled human infection model to facilitate product development and to advance understanding of host-pat...
Data monitoring committee interim reports: We must get there soon!
Data monitoring committee interim reports: We must get there soon!
Currently, too many Data Monitoring Committee Reports for interim review of trial progress are quite inadequate for Data M...
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Background/AimsWhen participants in individually randomized group treatment trials are treated by multiple clinicians or i...
Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials
Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials
BackgroundLimited information exists about the design of placebo-controlled cancer trials. Through a systematic review of ...
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials
BackgroundContemporary Phase I oncology trials often include efficacy expansion in various tumor indications post dose fin...
Choosing and changing the analysis scale in non-inferiority trials with a binary outcome
Choosing and changing the analysis scale in non-inferiority trials with a binary outcome
BackgroundThe size of the margin strongly influences the required sample size in non-inferiority and equivalence trials. W...
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)
BackgroundAddressing recruitment and retention challenges in trials is a key priority for methods research, but navigating...
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date
BackgroundThe Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Foo...
Commentary on Price and Scott: Complex innovative trial design
Commentary on Price and Scott: Complex innovative trial design
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Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)
Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)
Background/aimsSafe and effective therapies for COVID-19 are urgently needed. In order to meet this need, the Accelerating...
Clinical studies sponsored by digital health companies participating in the FDA’s Precertification Pilot Program: A cross-sectional analysis
Clinical studies sponsored by digital health companies participating in the FDA’s Precertification Pilot Program: A cross-sectional analysis
Victoria L Bartlett1, Sanket S Dhruva2, Nilay D Shah3, Joseph S Ross4, 51Yale School of Medicine, New Haven, CT, USA2S...
Why restricted mean survival time methods are especially useful for non-inferiority trials
Why restricted mean survival time methods are especially useful for non-inferiority trials
Access to society journal content varies across our titles. If you have access to a journal via a society or association ...
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial
Research in rapidly evolving policy contexts can lead to the following ethical challenges for sponsors and researchers: th...
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