Incorporating Toxicity Considerations Into the Design of Two-Stage Phase II Clinical Trials

DOI10.2307/2533268zbMATH Open0871.62090OpenAlexW1980032822WikidataQ70971469 ScholiaQ70971469MaRDI QIDQ4335635FDOQ4335635

Authors: John Bryant, Roger S. Day

Publication date: 12 June 1997

Published in: Biometrics (Search for Journal in Brave)

Full work available at URL: https://doi.org/10.2307/2533268

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zbMATH Keywords

phase II trials early stopping toxicity multiple endpoints group sequential designs control of error rates clinical response maximum expected accrual Simon designs two-stage clinical trials

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Sequential statistical analysis (62L10)

Cited In (24)

Designs for phase II trials with trade-of between efficacy and toxicity
Bayesian predictive monitoring with bivariate binary outcomes in phase II clinical trials
Some geometric methods for constructing decision criteria based on two-dimensional parame\-ters
Treatment Comparisons Based on Two‐Dimensional Safety and Efficacy Alternatives in Oncology Trials
On the maximum total sample size of a group sequential test about bivariate binomial propor\-tions
Decision-Theoretic Designs for Pre-Phase II Screening Trials in Oncology
Exact power calculations for detecting hypotheses involving two correlated binary outcomes
A Geometric Approach to Comparing Treatments for Rapidly Fatal Diseases
Ethical issues in oncology biostatistics
A curtailed procedure for selecting among treatments with two Bernoulli endpoints
Multivariate Markov models for the conditional probability of toxicity in phase II trials
A Bayesian Group Sequential Approach for Multiple Endpoints
Finding confidence bound using two-stage data
Group sequential designs for clinical trials with bivariate endpoints
Directed walk designs for dose-response problems with competing failure modes
On construction of single-arm two-stage designs with consideration of both response and toxicity
Efficacy and toxicity monitoring via Bayesian predictive probabilities in phase II clinical trials
Monitoring the rates of composite events with censored data in phase II clinical trials
Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes
Bayesian randomized clinical trials: A decision-theoretic sequential design
Testing statistical hypotheses on stochastic ordering of discrete distributions
Two-stage phase II trials with early stopping for effectiveness and safety as well as ineffectiveness or harm
A hybrid geometric phase II/III clinical trial design based on treatment failure time and toxicity
A review of phase 2-3 clinical trial designs

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