GSK teams up with NHS for ‘real world’ data study

GlaxoSmithKline (GSK) is collaborating with several NHS organisations, the University of Manchester and not-for-profit organisation Northwest e-Health to study the value of an investigational respiratory drug in a 'real world' setting in the UK.

The year-long Salford Lung Study will compare GSK's Relovair against current treatments for chronic obstructive pulmonary disease (COPD) and asthma, using electronic data collated in Salford's e-Health database to keep track of patient's progress outside a clinical trial setting.

The announcement of the study, the first of its kind, follows a muted response in January to top-line phase III data for the drug, which is one of the most important products in GSK's pipeline.

GSK says the new study will collect data from a variety of healthcare services in Salford including NHS Salford and the Salford Royal NHS Foundation, and that this will an advantage over clinical trial data because of the greater understanding of a patient's actual treatment and the real value of a medicine it can provide.

The Salford Lung Study team

Around 4,000 patients with COPD and 5,000 patients with asthma from Salford, will be enrolled in the study, with recruitment commencing in March for COPD patients, and May for asthma patients.

Half of each group will receive Relovair, while the other half of each group will receive their existing therapies. Patients will be monitored throughout the study using the e-Health database, with 'minimal intrusion' into their everyday lives. Other advantages over clinical trials include the removal of the need for enforced interventions and controls, according to GSK.

The company said this is the first time a 'large, prospective, “real-world” study has been performed on a pre-licence medicine, across a large population within one geographical setting'.

In a statement, the company said: "There is an increasing need for pharmaceutical companies to provide health technology assessment agencies and other healthcare decision makers with additional information on the health outcomes delivered by a medicine in the real world to establish the potential benefits and true value of a medicine."

Acknowledging this, GSK said it has discussed the study with UK health technology assessment (HTA) body the National Institute for Health and Clinical Excellence (NICE) and the country's regulator the Medicines and Healthcare products Regulatory Agency (MHRA).

The study would still be subject to "the usual regulatory and ethical requirements for traditional clinical trials", GSK said.

GSK's CEO Sir Andrew Witty recently questioning the way HTA bodies like NICE assess a drug's worth, and he claimed innovative oncology drugs suffered systematically delays before they could reach the market because they were deemed too expensive.

Responding to Witty's comments, NICE denied the accusations and said it produces evidence-based guidance on treatments and assesses whether the additional value of the technology justifies the price that the NHS is being asked to pay.

Other supporters of using real-world data to assess medicines include CEO of the UK's Association for the British Pharmaceutical Industry (ABPI) Stephen Whitehead.

In a speech announcing the ABPI report The Vision for Real World Data – Harnessing the Opportunities in the UK in September, Whitehead said the benefits of greater collaboration between NHS and industry to engage in such research would mean better management of chronic conditions and increased NHS savings.

Previously, in May 2011, the body published practical guidance on how to carry out a study in a real world setting and how to generate relevant data.