Challenges, opportunities, and innovative statistical designs for precision oncology trials.

ABSTRACT: In the era of precision oncology, improved understanding of tumor heterogeneity, particularly at the molecular level, has caused a shift from traditionally histology based cancer drug development to molecularly targeted drug development. The shift to the molecular view of cancer leads to increasingly small cancer populations for clinical trials which may be underpowered using traditional statistical designs. This paradigm shift lead to the recent developments of innovative clinical trial designs to address the challenges from precision oncology clinical trials. Hence, this paper reviewed and described innovative trial designs for precision oncology. Different strategies were discussed to account patient and treatment effect heterogeneity, including precision dose-finding designs that tailo

SUBMITTER: Yin J 

PROVIDER: S-EPMC9577796 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature