Safety data in randomised real-world evidence studies: Salford Lung Study learnings
| Autor: | Joanne L Fletcher, Nawar Diar Bakerly, Susan Collier, Courtney Crim, Hanaa Elkhenini, Ashley Woodcock, Lucy Frith, John P. New, Catherine Harvey, Jørgen Vestbo, Loretta Jacques, Claire Williams, Nasir Majeed, Glenn Cardwell |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pulmonary and Respiratory Medicine
medicine.medical_specialty business.industry MEDLINE Reviews Primary care Real world evidence 03 medical and health sciences 0302 clinical medicine 030228 respiratory system Clinical decision making Medicine Treatment strategy Narrative review Routine clinical practice In patient Medical physics 030212 general & internal medicine business |
| Zdroj: | ERJ Open Research, Vol 7, Iss 2 (2021) ERJ Open Research article-version (VoR) Version of Record |
| ISSN: | 2312-0541 |
| Popis: | 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. Using results from the Salford Lung Study, this review demonstrates that the understanding of safety data from randomised real-world evidence studies can be optimised by analysing both actual treatment received and randomisation group https://bit.ly/3p7zPXU |
| Databáze: | OpenAIRE |
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