Phase I Designs that Allow for Uncertainty in the Attribution of Adverse Events.
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ABSTRACT:
SUBMITTER: Iasonos A
PROVIDER: S-EPMC5659366 | biostudies-literature | 2017 Nov
REPOSITORIES: biostudies-literature
Publications
Phase I Designs that Allow for Uncertainty in the Attribution of Adverse Events.
Iasonos Alexia A O'Quigley John J
Journal of the Royal Statistical Society. Series C, Applied statistics 20161107 5
In determining dose limiting toxicities in Phase I studies, it is necessary to attribute adverse events (AE) to being drug related or not. Such determination is subjective and may introduce bias. In this paper, we develop methods for removing or at least diminishing the impact of this bias on the estimation of the maximum tolerated dose (MTD). The approach we suggest takes into account the subjectivity in the attribution of AE by using model-based dose escalation designs. The results show that g ...[more]
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