New research method questions traditional efficacy trial model

From University of Manchester:

Traditional efficacy trials have limited relevance to everyday clinical practice and should be changed, according the authors of a new study into chronic obstructive pulmonary disease (COPD) treatments.

The report (Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice) published today (4 September 2016) in the New England Journal of Medicine details a new method of testing effectiveness of drugs which puts the patients’ clinical experience at the heart of the process.

Led by Professors Jorgen Vestbo and Ashley Woodcock from The University of Manchester’s School of Biological Sciences, the research team conducted an effectiveness and safety trial of fluticasone furoate-vilanterol to manage COPD. Instead of a traditional randomised cohort selected using strict criteria, the new study used specific, representative patients drawn directly from GP practices in which they were receiving care for COPD.

Entitled the Salford Lung Study, the clinical trial recruited 2799 patients with COPD from 75 GP practices in and around Salford in Greater Manchester. The GP practices were involved in ensuring the study not only had access to specific COPD patients but also that the usual clinical care provided by the practices was built into the trials – the study was therefore rooted in a real clinical environment unlike tradition efficacy trial model.

“Our findings challenge the automatic transfer of findings from efficacy studies to clinical guidelines or everyday clinical practice,” said Prof Vestbo.

“Involving the GP practices in the Salford Lung Study allowed the team to create an unsupervised environment for the patients, enabling important factors in usual clinical care – such as adherence, frequency of dosing and persistence of good inhaler technique – to rightly influence the trial outcomes.

“This is a major deviation from the traditional model, but one we believe will deliver a more accurate set of results regarding effectiveness and safety of new medicines and treatments.”

The trial …

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