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Case study: Delivering commercial respiratory research in care homes

Community settings such as care homes and pharmacies offer unique opportunities to deliver research.

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Clinical need

Respiratory Syncytial Virus (RSV) can cause respiratory illnesses. Severe RSV illness can result in pneumonia (lung infection) and cause respiratory failure or death. So far, there is no effective treatment or vaccine available against RSV in adults.

Older adults have a higher risk of getting a severe RSV illness. This is due to weakening of the immune response and presence of additional diseases leading to an increased risk of serious illness. It is well known that RSV can cause severe respiratory illness in infants, but little is known about the severity of RSV respiratory illness in older adults living in the community or in long-term care facilities LTCF (e.g. care homes, residential homes, assisted living facilities).

Every year in the United States (US), about 207,000 people over age 65 will need to go to hospital because of RSV illness and about 16,000 die each year because of RSV illness. In Europe (including the UK), information on burden of disease due to RSV is limited.

Global pharmaceutical company, GlaxoSmithKline (GSK), is funding a prospective multi-centre study which is being conducted in various settings including hospitals, GP practices and care homes throughout Europe and US. The purpose of the study is to learn more about the burden of disease caused by RSV in people aged 50 years and older and to generate evidence which will support the development of an RSV vaccine by GSK in the future.

The community care home setting

About 2000 adults aged 50 years and above were invited to take part in this research study. In the UK approximately 100 participants were recruited in the community and 70 in LTCFs.

Participants will attend at least two scheduled visits and will then be followed by researchers for two years. During the study period participants will undergo a range of clinical assessments and fitness tests and will be regularly contacted during the RSV season (the winter months) for monitoring of respiratory illness. This will include blood samples and throat/nasal swabs being taken to check for RSV.

Sheena Gomez, GSK’s Clinical Trial Manager for the RSV study, explains the importance of being able to conduct this clinical study in care homes:

“This study is an epidemiological study, so it is looking at the incidence of RSV. By this we mean how many people are getting the virus and how it affects them”.

“All epidemiological studies require a good representation of the target patient population. In this case the target patient group is elderly people. We know that a large per cent of elderly people reside in care homes and Long Term Care Facilities, so it’s crucial that this setting is well represented in the research.

“At the same time, we know that there are challenges in achieving this as a low per cent of people in care homes tend to be involved in research. However, here in the UK research infrastructure exists to help us overcome that challenge.”

...here in the UK research infrastructure exists to help us overcome that challenge.

NIHR support and impact

In the UK the NIHR Clinical Research Network is funded by the government to support researchers to plan, set-up and deliver high quality research in England. Last year we recruited 870,250 participants into clinical studies and 46,064 of those participants were recruited into commercial clinical research. As you would expect, the majority of that recruitment took place in the UK’s National Health Service (NHS). However, the NIHR Clinical Research Network also supports research in community and social care settings. In 2013 the NIHR-funded Enabling Research In Care Homes (ENRICH) initiative was launched. The initiative has a dual purpose of helping researchers to access and engage care home residents and also to ensure that the care home residents have opportunities to take part in clinical research. There are currently over 850 research-ready care homes registered with ENRICH.  

This research infrastructure gave the GSK team confidence to bring this global study to the UK. Sheena Gomez continues:

We always look to work collaboratively with the NIHR Clinical Research Network on studies in the UK

“We always look to work collaboratively with the NIHR Clinical Research Network on studies in the UK and as soon as this study came to light we contacted the Network team. We looked to them for insight and support and also to assist with feasibility, and this is when they introduced us to the ENRICH initiative”.

“Care homes present a very different setting for delivering research. Knowing that there are care homes in the UK that are keen to be involved in delivering research and that are open and ready to collaborate with our principal investigators reassured us that the care home element of the study could be achieved. The Network team members also provided very useful insight into the operational side how care homes work which helped immensely in the planning.”

The study closed to recruitment at the end of September 2019 having achieved its recruitment target both globally and in the UK.

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