Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control
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 efficienc...
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| Format: | Article |
| Language: | English |
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Wiley
2012-01-01
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| Series: | Journal of Probability and Statistics |
| Online Access: | http://dx.doi.org/10.1155/2012/692725 |
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| _version_ | 1832549080122785792 |
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| author | Mourad Tighiouart André Rogatko |
| author_facet | Mourad Tighiouart André Rogatko |
| author_sort | Mourad Tighiouart |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-22e062d34fa246b88c3be1e8946e5094 |
| institution | Kabale University |
| issn | 1687-952X 1687-9538 |
| language | English |
| publishDate | 2012-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Probability and Statistics |
| spelling | doaj-art-22e062d34fa246b88c3be1e8946e50942025-02-03T06:12:17ZengWileyJournal of Probability and Statistics1687-952X1687-95382012-01-01201210.1155/2012/692725692725Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose ControlMourad Tighiouart0André Rogatko1Samuel Oschin Comprehensive Cancer Institute, 8700 Beverly Boulevard, Los Angeles, CA 90048, USASamuel Oschin Comprehensive Cancer Institute, 8700 Beverly Boulevard, Los Angeles, CA 90048, USAThe 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.http://dx.doi.org/10.1155/2012/692725 |
| spellingShingle | Mourad Tighiouart André Rogatko Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control Journal of Probability and Statistics |
| title | Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control |
| title_full | Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control |
| title_fullStr | Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control |
| title_full_unstemmed | Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control |
| title_short | Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control |
| title_sort | number of patients per cohort and sample size considerations using dose escalation with overdose control |
| url | http://dx.doi.org/10.1155/2012/692725 |
| work_keys_str_mv | AT mouradtighiouart numberofpatientspercohortandsamplesizeconsiderationsusingdoseescalationwithoverdosecontrol AT andrerogatko numberofpatientspercohortandsamplesizeconsiderationsusingdoseescalationwithoverdosecontrol |