Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control
Joint Authors
Cook-Wiens, Galen
Rogatko, André
Tighiouart, Mourad
Source
Journal of Probability and Statistics
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-10-02
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
We describe a design for cancer phase I clinical trials that takes into account patients heterogeneity thought to be related to treatment susceptibility.
The goal is to estimate the maximum tolerated dose (MTD) given patient’s specific dichotomous covariate value.
The design is Bayesian adaptive and is an extension of escalation with overdose control (EWOC).
We will assess the performance of this method by comparing the following designs via extensive simulations: (1) design using a covariate; patients are accrued to the trial sequentially and the dose given to a patient depends on his/her baseline covariate value, (2) design ignoring the covariate; patients are accrued to the trial sequentially and the dose given to a patient does not depend on his/her baseline covariate value, and (3) design using separate trials; in each group, patients are accrued to the trial sequentially and EWOC is implemented in each group.
These designs are compared with respect to safety of the trial and efficiency of the estimates of the MTDs via extensive simulations.
We found that ignoring a significant baseline binary covariate in the model results in a substantial number of patients being overdosed.
On the other hand, accounting for a nonsignificant covariate in the model has practically no effect on the safety of the trial and efficiency of the estimates of the MTDs.
American Psychological Association (APA)
Tighiouart, Mourad& Cook-Wiens, Galen& Rogatko, André. 2012. Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control. Journal of Probability and Statistics،Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-481344
Modern Language Association (MLA)
Tighiouart, Mourad…[et al.]. Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control. Journal of Probability and Statistics No. 2012 (2012), pp.1-10.
https://search.emarefa.net/detail/BIM-481344
American Medical Association (AMA)
Tighiouart, Mourad& Cook-Wiens, Galen& Rogatko, André. Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control. Journal of Probability and Statistics. 2012. Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-481344
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-481344