Design and Analysis of Phase I Clinical Trials

Recommendations

The treatment versus experimentation dilemma in dose finding studies
A new look at evaluating MTD designs in cancer research
Bayesian optimal designs for phase I clinical trials
Phase I (or Phase II) Dose-Ranging Clinical Trials: Proposal of a Two-Stage Bayesian Design
An assessment of up- and down designs and associated estimators in phase I trials

Cited in

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Performance Measures in Dose‐Finding Experiments
An application of reinforced urn processes to determining maximum tolerated dose
Competing designs for drug combination in phase I dose-finding clinical trials
Continual reassessment and related dose-finding designs
Stochastic approximation and modern model-based designs for dose-finding clinical trials
Group up-and-down designs for dose-finding
Design efficiency in dose finding studies
Sequential designs for ordinal phase I clinical trials
Two-stage phase II trials with early stopping for effectiveness and safety as well as ineffectiveness or harm
Phase I/II adaptive design for drug combination oncology trials
A method based on isotonic regression estimation for identifying the maximum tolerated dose
A hierarchical Bayesian design for phase I trials of novel combinations of cancer therapeutic agents
scientific article; zbMATH DE number 6428891 (Why is no real title available?)
Dose-finding design using mixed-effect proportional odds model for longitudinal graded toxicity data in phase I oncology clinical trials
A conversation with Nancy Flournoy
Flexible link continual reassessment methods for trivariate binary outcome phase I/II trials
Adaptive dose modification for phase I clinical trials
Escalation with overdose control for phase I drug-combination trials
The rapid enrollment design for phase I clinical trials
A new look at evaluating MTD designs in cancer research
A class of designs for phase I cancer clinical trials combining Bayesian and likelihood approaches
A simple technique to evaluate model sensitivity in the continual reassessment method
Approximate dynamic programming and its applications to the design of Phase I cancer trials
The treatment versus experimentation dilemma in dose finding studies
PoD-BIN: a probability of decision Bayesian interval design for time-to-event dose-finding trials with multiple toxicity grades
Design and Analysis of Clinical Trials
Dose-finding designs using a novel quasi-continuous endpoint for multiple toxicities
Adaptive prior variance calibration in the Bayesian continual reassessment method
A new design of the continual reassessment method
A note on continual reassessment method
Two-stage dose finding for cytostatic agents in phase I oncology trials
Statistical frameworks for oncology dose-finding designs with late-onset toxicities: a review
An assessment of up- and down designs and associated estimators in phase I trials
Utility-Based Optimization of Combination Therapy Using Ordinal Toxicity and Efficacy in Phase I/II Trials
STEIN: a simple toxicity and efficacy interval design for seamless phase I/II clinical trials
Operating characteristics of the standard phase I clinical trial design.
A Bayesian adaptive dose-finding algorithm for balancing individual- and population-level ethics in phase I clinical trials
Toxicity-dependent feasibility bounds for the escalation with overdose control approach in phase I cancer trials
Designs foe phase i cancer clinical trials with differentiation of graded toxicity
Bayesian optimal designs for phase I clinical trials
Optimal designs for dose-escalation trials and individual allocations in cohorts
Developing a Bayesian adaptive design for a phase I clinical trial: a case study for a novel HIV treatment
A default method to specify skeletons for Bayesian model averaging continual reassessment method for phase I clinical trials
A Bayesian adaptive phase I-II trial design for optimizing the schedule of therapeutic cancer vaccines
A robust two-stage design identifying the optimal biological dose for phase I/II clinical trials
The adaptive accelerated biased coin design for phase I clinical trials
Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
Bayesian Dose-Finding in Phase I/II Clinical Trials Using Toxicity and Efficacy Odds Ratios
PA‐CRM: A continuous reassessment method for pediatric phase I oncology trials with concurrent adult trials
Time-to-event continual reassessment method incorporating treatment cycle information with application to an oncology phase I trial
Optimal Bayesian-feasible dose escalation for cancer phase I trials
Designs for Phase I Clinical Trials with Multiple Courses of Subjects at Different Doses
Unifying CRM and EWOC designs for phase I cancer clinical trials
A continual reassessment method without undue risk of toxicity
Testing simultaneous hypotheses in pharmaceutical trials: a bayesian approach
Continual reassessment method for partial ordering
scientific article; zbMATH DE number 7370531 (Why is no real title available?)
Sequential method of estimating the LD₅₀ using a modified up-and-down rule
A Latent Contingency Table Approach to Dose Finding for Combinations of Two Agents
Incoherent dose-escalation in phase I trials using the escalation with overdose control approach
The Continual Reassessment Method for Multiple Toxicity Grades: A Bayesian Quasi‐Likelihood Approach
A modified Huber loss function for continual reassessment methods in clinical trials
A simulation-free approach to assessing the performance of the continual reassessment method
Fractional accumulative calibration-free odds (f-aCFO) design for delayed toxicity in phase I clinical trials
REDOMA: Bayesian random-effects dose-optimization meta-analysis using spike-and-slab priors
Likelihood‐Based Experimental Design for Estimation of Ed 50
A novel approach for propensity score matching and stratification for multiple treatments: application to an electronic health record-derived study
A combined criterion for optimizing doses in phase I clinical trials
Applying the partial order continual reassessment method to high-dimensional treatment combinations
Patient retreat in dose escalation for phase I clinical trials with rare diseases
scientific article; zbMATH DE number 590042 (Why is no real title available?)
Comparative review of novel model-assisted designs for phase I/II clinical trials
A nonparametric Bayesian method for dose finding in drug combinations cancer trials
A machine learning compatible method for ordinal propensity score stratification and matching
A Bayesian adaptive phase i/II platform trial design for pediatric immunotherapy trials
Bayesian modeling of a bivariate toxicity outcome for early phase oncology trials evaluating dose regimens
Early completion of phase I cancer clinical trials with Bayesian optimal interval design
Methodology and application of adaptive and sequential approaches in contemporary clinical trials
Number of patients per cohort and sample size considerations using dose escalation with overdose control
Determining a Maximum‐Tolerated Schedule of a Cytotoxic Agent
Comment on: ``Improving the performance of Bayesian logistic regression model with overdose control in oncology dose-finding studies
Dose finding studies for therapies with late-onset toxicities: a comparison study of designs
Bayesian optimization for personalized dose-finding trials with combination therapies
A semi-Markov model for patient progression through clinical trials
A semi-Markov process for the K-in-a-Row design
Theoretical study of the continual reassessment method
Motivating sample sizes in adaptive phase I trials via Bayesian posterior credible intervals
Analyzing longitudinal count data from adaptive clinical trials: a weighted generalized quasi-likelihood approach
Semiparametric Dose Finding Methods for Partially Ordered Drug Combinations
Adaptive clinical trial designs for phase I cancer studies
SEQUENTIAL METHODS IN CLINICAL TRIALS*
Dose-finding with two agents in phase I oncology trials
A Parallel Phase I/II Clinical Trial Design for Combination Therapies
The locally active-controlled optimal design: applications in oncology clinical studies
Bayesian phase I/II adaptively randomized oncology trials with combined drugs
Review of Statistical Treatment for Oncology Dose-Escalation Trial with Prolonged Evaluation Window or Fast Enrollment
Causal inference in early phase clinical trials: variance decomposition and order of patient inclusion
The role of minimal sets in dose finding studies
A sequential design for maximizing the probability of a favourable response
A Comparative Analysis of Phase I Dose-Finding Designs Incorporating Pharmacokinetics Information

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