UK shows lead in real-world research after lung trial success

The UK is positioning itself as a one-stop shop for clinical research, following a ground-breaking respiratory “real world” study undertaken by GSK.

GlaxoSmithKline and Innoviva’s Salford Lung Study this week showed that Relvar Ellipta (fluticasone+vilanterol) achieved a superior reduction in exacerbations versus usual care in patients with chronic obstructive pulmonary disease (COPD) in an everyday clinical practice setting.

Safety data showed that in pneumonia, a serious adverse event of special interest, Relvar Ellipta demonstrated non-inferiority versus usual care – a post-marketing endpoint requested by the European Medicines Agency.

The Westminster Health Forum conference heard that the UK aims to become a centre of excellence for such “real world” trials, which, aside from helping pharma clear regulatory hurdles, can be used to generate data for pricing discussions.

The conference heard from Howard Overy, IT director of North West eHealth, an IT company that provided support for the Salford study, which tracked patients in real-world settings to gather data on COPD exacerbations leading to hospital visits.

This kind of study will also provide patient-reported data on how patients value their drugs, said Overy, who added that such patient-reported outcomes should be incorporated into trial designs.

“A patient might be more interested in walking up a flight of stairs to play with their grandchildren – we need to build patient related endpoints into clinical trials,” said Overy at the conference on priorities for healthcare research.

Meanwhile, Dr Janet Valentine, director of the Clinical Practice Research Datalink, a government funded database containing anonymised information from the UK’s GP practice network, also outlined how she hoped the UK will become global centre for real world studies.

Valentine told pharmaphorum that she hoped the UK’s Medical Research Council could provide initial support and funding for pre-clinical research, while the Clinical Research Network would support phase 3 trials.

The CPRD could then be used to provide “real world” data post-approval. She said: “It is a really cheap way of doing it – it is the way of the future. I want to build our reputation for post-marketing work.”

As the CPRD is jointly funded by the UK’s regulator and the National Institute of Health Research it cannot provide real world data for clinical trials as this could be a conflict of interest – but Valentine said can help identify patients to streamline the recruitment process.

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