PT - JOURNAL ARTICLE AU - Catherine Harvey AU - Ashley Woodcock AU - Jørgen Vestbo AU - Courtney Crim AU - Lucy Frith AU - Nawar Diar Bakerly AU - John P. New AU - Claire Williams AU - Hanaa Elkhenini AU - Nasir Majeed AU - Glenn Cardwell AU - Susan Collier AU - Loretta Jacques AU - Joanne Fletcher TI - Safety data in randomised real-world evidence studies: Salford Lung Study learnings AID - 10.1183/23120541.00966-2020 DP - 2021 Jan 01 TA - ERJ Open Research PG - 00966-2020 4099 - http://openres.ersjournals.com/content/early/2021/02/04/23120541.00966-2020.short 4100 - http://openres.ersjournals.com/content/early/2021/02/04/23120541.00966-2020.full AB - 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 actual treatment exposure.We demonstrate that analysing safety data by actual treatment received (i.e. accounting for the treatment modifications that occur routinely in the primary care setting) provides additional insight beyond analysing according to randomised treatment strategy only.It is therefore proposed that understanding of safety data from RRWE trials can be optimised by analysing both by randomised group and by actual treatment received.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: C. Harvey reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and she is an employee of and holds shares/options in GlaxoSmithKline.Conflict of interest: A. Woodcock reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and a speaker fee and expenses ($3491.62) from GlaxoSmithKline, and advisory fees and expenses ($4998.95) from Chiesi, outside the submitted work. He is also chairman/shareholder of Reacta Biotech, a university spinout manufacturing food challenge materials for allergy.Conflict of interest: J. Vestbo reports fees for attending six steering committee meetings over the study period from GlaxoSmithKline; and consultancy for COPD phase 2 and 3 programmes and payment for lectures including service in speaker bureaus from GlaxoSmithKline and Chiesi Pharmaceuticals, consultancy for COPD phase 2 and 3 programmes and payment for lectures including service in speaker bureau, and a biomarker study grant from Boehringer-Ingelheim, and consultancy for COPD phase 2 and 3 programes and payment for lectures including service in speaker bureaus from Novartis and AstraZeneca, outside the submitted work.Conflict of interest: C. Crim reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and she is an employee of and holds shares/options in GlaxoSmithKline.Conflict of interest: L. Frith reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and she is an employee of and holds shares/options in GlaxoSmithKline.Conflict of interest: N.D. Bakerly reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and grants and personal fees from GlaxoSmithKline and Novartis, support for congress attendance from Boehringer Ingelheim, and grants and personal fees from Almirall/AstraZeneca, outside the submitted work.Conflict of interest: J.P. New reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline.Conflict of interest: C. Williams reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; in addition, she was an employee of GlaxoSmithKline during the Salford Lung Studies.Conflict of interest: H. Elkhenini rreports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline.Conflict of interest: N. Majeed reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline.Conflict of interest: G. Cardwell reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and he is an employee of and holds shares/options in GlaxoSmithKline.Conflict of interest: Dr. Collier reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.Conflict of interest: L. Jacques reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and she is an employee of and holds shares/options in GlaxoSmithKline.Conflict of interest: J. Fletcher reports reports this study was funded by GlaxoSmithKline and medical writing support by Gardiner-Caldwell Communications was also funded by GlaxoSmithKline; and she is an employee of and holds shares/options in GlaxoSmithKline.