Estimands in CNS trials - A review of strategies for addressing intercurrent events.

ABSTRACT:

Background

The estimands framework represents a significant innovation for the design, conduct, analysis, and interpretation of clinical trials. An aim of the framework is to increase precision and transparency on the handling of intercurrent events (IEs), defined as events occurring after treatment initiation and affecting the endpoint. While the experience in constructing and reporting estimands in the published literature is limited, developers performing confirmatory studies are already making use of the new paradigm, allowing to survey the strategies proposed by applicants and endorsed by regulators.

Methods

To identify strategies for handling IEs in confirmatory central nervous system (CNS) trials, we searched scientific advice letters issued by the European Medicines

SUBMITTER: Meszaros L 

PROVIDER: S-EPMC10878841 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature