A new pragmatic design for dose escalation in phase 1 clinical trials using an adaptive continual reassessment method.

ABSTRACT:

Background

A key challenge in phase I trials is maintaining rapid escalation in order to avoid exposing too many patients to sub-therapeutic doses, while preserving safety by limiting the frequency of toxic events. Traditional rule-based designs require temporarily stopping recruitment whilst waiting to see whether enrolled patients develop toxicity. This can be both inefficient and introduces logistic challenges to recruitment in the clinic. We describe a novel two-stage dose assignment procedure designed for a phase I clinical trial (STARPAC), where a good estimation of prior was possible.

Methods

The STARPAC design uses rule-based design until the first patient has a dose limiting toxicity (DLT) and then switches to a modified CRM, with rules to handle patient recruitment

SUBMITTER: North B 

PROVIDER: S-EPMC6595589 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature