Umbrella and basket trials in oncology: ethical challenges.

ABSTRACT:

Background

Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute - Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study.

Main body

We discuss three ethical requirements for clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunit

SUBMITTER: Strzebonska K 

PROVIDER: S-EPMC6708208 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature