Table 4.

Key points from Salford Lung Study

Trial name (registration)	Salford lung Study21 (Extension=NCT03152669)
Sponsorship	Industry – GlaxoSmithKline.
Clinical setting	Chronic obstructive pulmonary, UK only: regional.
Design	Early-phase, cluster randomised trial run in one geographic location.
Size	N=7200.
Key outcome measure	COPD exacerbation rates.
Rationale for presentation	Conduct and follow-up, collecting data on benefits and harms.
Key discussion points	The study was the first in the world to have evaluated the effectiveness and safety of a prelicenced medicine compared with standard of care when used in every day clinical practice in patients with COPD. Patients were randomised at their routine GP respiratory review visit and constant monitored through the 12-month study via real time data collection from GP and hospitals. Data was also collected from participating community pharmacies and from Office For National Statistics mortality and Secondary User Service national datasets and an out of hours phone service. A safety alerting and reporting system was established based on serious adverse events being initially flagged in the EHR followed by review by the safety team and the principal investigator prior to submission to the sponsor as appropriate. Lessons learnt were to ensure at the design phase that all the safety and endpoints of the study could be readily captured and the importance of early engagement with the regulators and National Institute of Health and Care Excellence. The study demonstrated that safety monitoring in this type of real-wold study was effective, could be done close to real time and was highly configurable. Widespread adoption could improve safety and such systems lend themselves to novel trial designs.

COPD, chronic obstructive pulmonary disease; EHR, electronic healthcare record.