Medications for chronic obstructive pulmonary disease: a historical non-interventional cohort study with validation against RCT results

Autor: Kevin Wing, Elizabeth Williamson, James R Carpenter, Lesley Wise, Sebastian Schneeweiss, Liam Smeeth, Jennifer K Quint, Ian Douglas

Publikováno v: Health Technology Assessment, Vol 25, Iss 51 (2021)

Background: Chronic obstructive pulmonary disease treatment is informed by randomised controlled trial results, but it is unclear if these findings apply to people excluded from these trials. We used data from the TORCH (TOwards a Revolution in COPD

Externí odkaz: https://doaj.org/article/03acb4f3e3334bcdb6244d11fc5e3e4c

Real world effects of COPD medications:a cohort study with validation against results from randomised controlled trials

Autor: Elizabeth A. Williamson, Ian J. Douglas, Liam Smeeth, Lesley Wise, Kevin Wing, Jennifer K Quint, James R. Carpenter, Sebastian Schneeweiss

Publikováno v: Wing, K, Williamson, E, Carpenter, J R, Wise, L, Schneeweiss, S, Smeeth, L, Quint, J K & Douglas, I 2021, ' Real world effects of COPD medications : a cohort study with validation against results from randomised controlled trials ', European Respiratory Journal, vol. 57, no. 3, 2001586 . https://doi.org/10.1183/13993003.01586-2020
The European Respiratory Journal
article-version (VoR) Version of Record

Real-world data provide the potential for generating evidence on drug treatment effects in groups excluded from trials, but rigorous, validated methodology for doing so is lacking. We investigated whether non-interventional methods applied to real-wo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0243acce4fb27067a906053d149c45f6
https://www.pure.ed.ac.uk/ws/files/313308535/Real_world_effects_of_COPD_medications.pdf

Real World Effects of Medications for COPD - a UK Population-Based Non-Interventional Cohort Study With Validation Against Randomised Trial Results

Autor: Elizabeth Williamson, Jennifer K Quint, Lesley Wise, Ian J. Douglas, James R. Carpenter, Liam Smeeth, Kevin Wing, Sebastian Schneeweiss

Publikováno v: Airway pharmacology and treatment.

Background: COPD treatment is informed by RCT results, which may not apply to all patients. Non-interventional studies include groups excluded from trials, but their use to estimate treatment effectiveness is unproven. Objectives: To use (1) individu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ef35ea4a79d951533dd66a3a343d77b0
https://doi.org/10.1183/13993003.congress-2019.pa2508

The changing face of (benefit-)risk management

Autor: Lesley Wise

Publikováno v: Medical Writing. 24:62-65

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning pharmacovigilan

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::8a748077fc296419902af10a370f8006
https://doi.org/10.1179/2047480615z.000000000286

Development of a Novel Regulatory Pharmacovigilance Prioritisation System: An Evaluation of Its Performance at the UK Medicines and Healthcare products Regulatory Agency

Autor: Suzie Seabroke, Lesley Wise, Patrick Waller

Publikováno v: Drug Safety. 36:1025-1032

The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::438cf8eadb7317b15c7dddf5d545a5a4
https://doi.org/10.1007/s40264-013-0081-3