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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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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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Safe Exploration in Dose Finding Clinical Trials with Heterogeneous Participants
In drug development, early phase dose-finding clinical trials are carried out to identify an optimal dose to administer to patients in larger...
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Dose-Finding and Dose-Ranging Studies
There is a growing recognition of the importance of well-designed dose-finding studies in the overall development process. This chapter is an...
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A new function for drug combination dose finding trials
Combination drugs play an essential role in treating cancers. The challenging part of the combination drugs are to specify the dose-toxicity...
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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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Dose Finding for Drug Combinations
We present early phase cancer clinical trial designs for drug combinations focusing on continuous dose levels. For phase I trials, the goal is to...
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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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Introduction to Phase I Dose-Finding Clinical Trials
The primary objective of phase I oncology trials is to identify the maximum tolerated dose (MTD) of an investigational drug to inform the dose to be...
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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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Efficacy-Driven Dose Finding with Toxicity Control in Phase I Oncology Studies
Traditionally, dose-finding process for oncology compound is carried out in phase I dose escalation study and is driven by safety in order to find...
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Oral mannitol for bowel preparation: a dose-finding phase II study
BackgroundSuccessful bowel preparation (BP) for colonoscopy depends on the instructions, diet, the laxative product, and patient adherence, which all...
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Measuring Adaptive Responses Following Chronic and Low Dose Exposure in Amphibians
Adaptive responses can be used as biological indicators of chronic low dose exposure to ionizing radiation. The micronucleus assay has been used to...
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Dose-Finding and Dose-Ranging Studies
There is a growing recognition of the importance of well-designed dose-finding studies in the overall development process. This chapter is an...
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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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Adaptive immune responses to two-dose COVID-19 vaccine series in healthy Canadian adults ≥ 50 years: a prospective, observational cohort study
To evaluate immune responses to COVID-19 vaccines in adults aged 50 years and older, spike protein (S)-specific antibody concentration, avidity, and...
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Approaches to Combining Phase II Proof-of-Concept and Dose-Finding Trials
There are two objectives in Phase II clinical development: establishing proof-of-concept that the drug is efficacious (PoC) and identifying an...
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Optimal Biological Dose and Phase I/II Trials
The conventional phase I trial design paradigm is based on the more-is-better assumption, which may not be true for immunotherapies and targeted...