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

ConclusionIntegration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Source: Pharmacoepidemiology and Drug Safety - October 31, 2016 Category: Drugs & Pharmacology Authors: Sue Collier, Catherine Harvey, Jill Brewster, Nawar Diar Bakerly, Hanaa F. Elkhenini, Roxana Stanciu, Claire Williams, Jacqui Brereton, John P. New, John McCrae, Sheila McCorkindale, David Leather Tags: Original Report Source Type: research