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Rapid enrollment design for finding the optimal dose in immunotherapy trials with ordered groups
Xiaoqiang Xue1, Matthew C Foster2, Anastasia Ivanova3
1a Decision Sciences, Data Science Safety and Regulatory, IQVIA Inc. , Durham , NC , USA.
Journal of Biopharmaceutical Statistics
|June 29, 2019
Summary
This study extends the rapid enrollment design for immunotherapy dose-finding trials to identify optimal doses. It also addresses using this design for trials with ordered groups, improving dose estimation by considering toxicity and response monotonicity.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Immunotherapy dose-finding trials differ from cytotoxic therapies due to unique toxicity-response relationships.
- Longer follow-up periods for toxicity and response are crucial in immunotherapy trials.
- The rapid enrollment design facilitates timely patient allocation in dose-finding studies.
Purpose of the Study:
- To extend the rapid enrollment design for optimal dose finding in immunotherapy trials.
- To adapt the design for immunotherapy trials involving ordered groups with varying efficacy and toxicity.
- To enhance optimal dose estimation by leveraging monotonicity across groups.
Main Methods:
- Extension of the rapid enrollment design for immunotherapy dose-finding.
- Application of the design to immunotherapy trials with ordered groups.
- Utilizing toxicity and response monotonicity for improved dose estimation.
Main Results:
- The extended rapid enrollment design effectively identifies optimal doses in immunotherapy.
- The design is adaptable for trials with ordered groups, accommodating inter-group variations.
- Monotonicity of toxicity and response across groups can improve optimal dose estimation.
Conclusions:
- The rapid enrollment design offers a viable approach for immunotherapy dose-finding.
- The methodology accommodates complex trial designs, including those with ordered subgroups.
- Leveraging group-wise monotonicity enhances the precision of optimal dose selection in immunotherapy.
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