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- Title
Continuous Toxicity Monitoring in Phase II Trials in Oncology.
- Authors
Ivanova, Anastasia; Qaqish, Bahjat F.; Schell, Michael J.
- Abstract
The goal of a phase II trial in oncology is to evaluate the efficacy of a new therapy. The dose investigated in a phase II trial is usually an estimate of a maximum-tolerated dose obtained in a preceding phase I trial. Because this estimate is imprecise, stopping rules for toxicity are used in many phase II trials. We give recommendations on how to construct stopping rules to monitor toxicity continuously. A table is provided from which Pocock stopping boundaries can be easily obtained for a range of toxicity rates and sample sizes. Estimation of the probability of toxicity and response is also discussed.
- Subjects
CLINICAL trials; CLINICAL medicine; THERAPEUTICS; TOXICITY testing; ESTIMATION theory; ONCOLOGY
- Publication
Biometrics, 2005, Vol 61, Issue 2, p540
- ISSN
0006-341X
- Publication type
Article
- DOI
10.1111/j.1541-0420.2005.00311.x