Trends in the crossover of patients in phase III oncology clinical trials in the USA.

ABSTRACT:

Background

The incorporation of crossover in randomised controlled trials is accepted as an ethical obligation, especially in cancer clinical trials. The more common type of crossover is crossover allowance, which allows patients assigned to one arm to switch to another arm if there is an established benefit in the crossover arm. In contrast, crossover-designed studies involve switching patients from all arms to a different arm as part of the study design. Crossover allowance may have advantages in patient recruitment and incorporating crossover after initial positive results fulfil ethical requirements. However, crossover can also contribute to confounding major endpoints of studies, such as overall survival or the second progression-free survival interval. For this reason, it is

SUBMITTER: Yeh J 

PROVIDER: S-EPMC7738270 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature