Safety data in randomised real-world evidence studies: Salford Lung Study learnings.

ABSTRACT: Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of medicines in patients and settings representative of routine clinical practice. However, elements that underpin the design of RRWE studies can have a significant impact upon the analysis, interpretation and implications of safety data. In this narrative review, we use data from the Salford Lung Study; two prospective, 12-month, open-label, parallel-group, phase III randomised controlled trials conducted in primary care in the UK; to highlight the importance of capturing treatment modifications when attempting to evaluate safety events according to

SUBMITTER: Harvey C 

PROVIDER: S-EPMC8165374 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature