Series: Pragmatic trials and real world evidence: Paper 7. Safety, quality and monitoring

Journal of Clinical Epidemiology
Elaine IrvingGetReal Work Package 3

Abstract

Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorization. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials. This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that all serious adverse events and all drug-related events must be reported in an interventional trial. In line with current guidance, we propose a risk-based approach to the collection of non-drug-related non-serious adverse events and even serious events not related to treatment based on the risk profile of the medicine/class in the patient population of interest. Different options available to support the collection and reporting of safety data while minimizing study-related follow-up visits are discussed. A risk-based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials and the careful consideration...Continue Reading

References

Feb 20, 2008·Clinical Trials : Journal of the Society for Clinical Trials·Colin BaigentDouglas G Altman
May 20, 2008·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Joyce de LangenKees van Grootheest
Nov 10, 2009·Clinical Trials : Journal of the Society for Clinical Trials·Oana BrosteanuUlrike Zettelmeyer
Aug 13, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·David J McLernonUNKNOWN Yellow Card Collaboration
Jul 7, 2011·Clinical Trials : Journal of the Society for Clinical Trials·Briggs W MorrisonJames D Neaton
Aug 26, 2011·Thorax·George N Konstantinou
May 4, 2012·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Anjan K Banerjee, Simon Ingate
Mar 20, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Keith B HoffmanBrian M Overstreet
May 16, 2017·Journal of Clinical Epidemiology·Sally D WorsleyUNKNOWN GetReal Work Package 3
May 28, 2017·Journal of Clinical Epidemiology·Mira G P ZuidgeestUNKNOWN GetReal Work Package 3

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