Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control

المؤلفون المشاركون

Cook-Wiens, Galen
Rogatko, André
Tighiouart, Mourad

المصدر

Journal of Probability and Statistics

العدد

المجلد 2012، العدد 2012 (31 ديسمبر/كانون الأول 2012)، ص ص. 1-10، 10ص.

الناشر

Hindawi Publishing Corporation

تاريخ النشر

2012-10-02

دولة النشر

مصر

عدد الصفحات

10

التخصصات الرئيسية

الرياضيات

الملخص 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.

نمط استشهاد جمعية علماء النفس الأمريكية (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

نمط استشهاد الجمعية الأمريكية للغات الحديثة (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

نمط استشهاد الجمعية الطبية الأمريكية (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

نوع البيانات

مقالات

لغة النص

الإنجليزية

الملاحظات

Includes bibliographical references

رقم السجل

BIM-481344