The Salford lung study in COPD

Published on November 1, 2017   32 min

A selection of talks on Pharmaceutical Sciences

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My name is Dave Leather, and I work for GSK in the Global Respiratory Franchise. Today I'm going to be talking about the Salford lung study, in COPD. And I was one of the leads on the Salford lung study. What I'm going to be talking about, is a little bit about the background of this study, why we did it, a little about how we did it, and also tell you a bit about the results, and some of the outcomes from this study.
My conflict of interests, clearly, I'm a full time employee of GSK, and I hold stocks and shares in GSK.
Throughout this presentation, the investigational product in this study is Relvar Breo Ellipta device. This is a fluticasone vilanterol combination inhaler. And from here on, I'll refer to that as, FF/VI just for simplicity reasons.
So firstly a little bit about the background. Why did we decide to do a study that was different? Well, we've been hearing calls from different groups about the needs for different types of data. People have been used to looking at the efficacy data, but there was a call coming out now for looking at effectiveness. This is really thinking about the effect of a medicine in everyday clinical practice, not just from its efficacy perspective, but from a safety perspective, the risk benefit, value for money, and thinking not just about the individual, but the community. These calls have been coming from a variety of corners particularly from payers, and Health Technology Assessment groups who've long struggled with trying to take efficacy data from double blind randomized controlled trials, and translate that into relevant populations, who ultimately receive the medicine. Guideline writers I think have also struggled with the same problem. How do you translate very strictly controlled trial data, into a clinical guideline? I think generally health care professionals also found that some of the data that they were looking at wasn't relevant to their everyday clinical practice. So there was a sort of sense in the background, that maybe new types of data would be useful to inform the users and payers and patients actually taking medicines.