Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

ABSTRACT:

Background

The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records.

Objective

The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications.

Achievements<

SUBMITTER: Collier S 

PROVIDER: S-EPMC5347861 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature