Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control
Joint Authors
Rogatko, André
Tighiouart, Mourad
Source
Journal of Probability and Statistics
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-16, 16 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-10-11
Country of Publication
Egypt
No. of Pages
16
Main Subjects
Abstract EN
The main objective of cancer phase I clinical trials is to determine a maximum tolerated dose (MTD) of a new experimental treatment.
In practice, most of these trials are designed so that three patients per cohort are treated at the same dose level.
In this paper, we compare the safety and efficiency of trials using the escalation with overdose control (EWOC) scheme designed with three or only one patient per cohort.
We show through simulations that the number of patients per cohort does not impact the proportion of patients given therapeutic doses, safety of the trial, and efficiency of the estimate of the MTD.
Additionally, we present guidelines and tabulated values on the number of patients needed to design a phase I cancer clinical trial using EWOC to achieve a given accuracy of the estimate of the MTD.
American Psychological Association (APA)
Tighiouart, Mourad& Rogatko, André. 2012. Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control. Journal of Probability and Statistics،Vol. 2012, no. 2012, pp.1-16.
https://search.emarefa.net/detail/BIM-491032
Modern Language Association (MLA)
Tighiouart, Mourad& Rogatko, André. Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control. Journal of Probability and Statistics No. 2012 (2012), pp.1-16.
https://search.emarefa.net/detail/BIM-491032
American Medical Association (AMA)
Tighiouart, Mourad& Rogatko, André. Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control. Journal of Probability and Statistics. 2012. Vol. 2012, no. 2012, pp.1-16.
https://search.emarefa.net/detail/BIM-491032
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-491032