The Future Glioblastoma Clinical Trials Landscape: Early Phase 0, Window of Opportunity, and Adaptive Phase I–III Studies
Abstract Purpose of Review Innovative clinical trial designs for glioblastoma (GBM) are
needed to expedite drug discovery. Phase 0, window of opportunity, and adaptive designs …
needed to expedite drug discovery. Phase 0, window of opportunity, and adaptive designs …
A survey of online experiment design with the stochastic multi-armed bandit
Adaptive and sequential experiment design is a well-studied area in numerous domains. We
survey and synthesize the work of the online statistical learning paradigm referred to as multi …
survey and synthesize the work of the online statistical learning paradigm referred to as multi …
On optimal designs for clinical trials: an updated review
Optimization of clinical trial designs can help investigators achieve higher quality results for
the given resource constraints. The present paper gives an overview of optimal designs for …
the given resource constraints. The present paper gives an overview of optimal designs for …
Dose optimization for novel oncology agents: design options and strategies
Over the past decade, drug development in oncology has shifted from cytotoxic agents to
drugs with new mechanisms of action, such as cancer immunotherapies, targeted …
drugs with new mechanisms of action, such as cancer immunotherapies, targeted …
Nonparametric overdose control with late-onset toxicity in phase I clinical trials
Under the framework of Bayesian model selection, we propose a nonparametric overdose
control (NOC) design for dose finding in phase I clinical trials. Each dose assignment is …
control (NOC) design for dose finding in phase I clinical trials. Each dose assignment is …
Designing phase I oncology dose escalation using dose–exposure–toxicity models as a complementary approach to model‐based dose–toxicity models
K Pantoja, S Lanke, A Munafo, A Victor… - CPT …, 2022 - Wiley Online Library
One of the objectives of oncology phase I dose‐escalation studies has been to determine
the maximum tolerated dose (MTD). Although MTD is no longer set as the dose for further …
the maximum tolerated dose (MTD). Although MTD is no longer set as the dose for further …
A flexible dose-response modeling framework based on continuous toxicity outcomes in phase I cancer clinical trials
SY Lee - Trials, 2023 - Springer
Background The past few decades have seen remarkable developments in dose-finding
designs for phase I cancer clinical trials. While many of these designs rely on a binary …
designs for phase I cancer clinical trials. While many of these designs rely on a binary …
Phase I dose-escalation oncology trials with sequential multiple schedules
Background Conventional methods for phase I dose-escalation trials in oncology are based
on a single treatment schedule only. More recently, however, multiple schedules are more …
on a single treatment schedule only. More recently, however, multiple schedules are more …
Pharmacometrics meets statistics—A synergy for modern drug development
Modern drug development problems are very complex and require integration of various
scientific fields. Traditionally, statistical methods have been the primary tool for design and …
scientific fields. Traditionally, statistical methods have been the primary tool for design and …
[HTML][HTML] Systematic comparison of the statistical operating characteristics of various Phase I oncology designs
R Ananthakrishnan, S Green, M Chang, G Doros… - Contemporary clinical …, 2017 - Elsevier
Dose finding Phase I oncology designs can be broadly categorized as rule based, such as
the 3+ 3 and the accelerated titration designs, or model based, such as the CRM and Eff-Tox …
the 3+ 3 and the accelerated titration designs, or model based, such as the CRM and Eff-Tox …