Why you should deliver respiratory disorders research in the UK
The Respiratory Disorders Specialty is one of the top 10 specialties within the NIHR Clinical Research Network (CRN) for study activity. Our membership is made up of research-interested clinicians and practitioners at both national and local levels, who work to ensure that over 200 studies included in the NIHR CRN Portfolio of clinical research receive the right support to be delivered successfully at sites within the NHS and the wider health and social care environment in England. We cover common respiratory disorders such as asthma and Chronic Obstructive Pulmonary Disease (COPD) (10 per cent and up to five per cent of the UK population respectively). We are increasingly involved in traditionally neglected areas now having a resurgence in research such as pulmonary fibrosis and bronchiectasis.
Leadership
The Respiratory Disorders Specialty comprises of national and international key opinion leaders. All regions in England and the devolved nations of Scotland, Wales and Northern Ireland have representation in our group. We have a dedicated National Industry Lead for commercial studies who provides strategic direction as well as an operational link between industry, the NIHR and researchers.
The Specialty also connects with global research leaders delivering research in all areas of respiratory medicine.
Access to patients
The Respiratory Disorders Specialty is active in common diseases such as asthma and COPD. Importantly there is now significant expertise, activity and success in trials in areas that include more rare diseases such as cystic fibrosis, idiopathic pulmonary fibrosis (IPF), bronchiectasis, pulmonary hypertension, sarcoidosis and many others.
More than 24,000 participants were recruited into CRN Respiratory Disorders studies in 2018/19 and approximately 78 per cent of acute trusts recruited a respiratory participant into a study.
Track record
In 2018/19, 84 per cent of Respiratory Disorders studies recruited to time and target - both commercial and non-commercial sponsored studies attained the NIHR benchmark of 80 per cent or beyond.
This reflects the rigorous processes in place for setting accurate recruitment targets. We have set national targets for industry studies (across common and rare respiratory diseases), and welcome a collaborative approach to working with industry including feedback on target setting.
We are now active in both drug treatment and medical technology trials, such as endobronchial devices and pleural catheters.
We have mapped the most successful respiratory sites over the last six years and are keen to ensure these sites continue to be offered new industry studies.
We work across several specialties including Primary Care, Ear, Nose and Throat (ENT), Musculoskeletal, Children, Critical Care and Cardiovascular Disease.
Exemplars of this cross specialty working include the recruitment of participants in primary care in industry sponsored studies such as the Salford Lung study (more than 2,800 participants recruited) and academic studies such as the NIHR Heath Technology assessment funded TWICS study (more than 1,500 participants recruited).
Our impact case studies include those leading to Mepoluzimab being adopted into UK practice in asthma management.
We work collaboratively with national charities such as Asthma UK, British Lung Foundation and the Cystic Fibrosis Trust.
Support
We actively manage study performance through direct involvement of the National Specialty Lead, specific members of the specialty group and the NIHR CRN Industry team. We can identify experts for protocol review across medical and nursing backgrounds to provide in-depth advice on deliverability.
We facilitate discussions with sponsors, providing early feedback and suggesting strategies for site selection and improved recruitment. Our strategic analysis from over five years of performance data provides us with a broad overview to advise on site selection.
Case studies: Salford Lung study
GlaxoSmithKline’s (GSK) Salford Lung study is considered the first of its kind globally – a large, prospective, real-world trial conducted across a patient population within a single geographical setting.
The study evaluated a new treatment for COPD and asthma patients in a way that combines the robust scientific methodology of a randomised controlled trial - the gold standard in clinical trials - with the benefits of observing ‘real patients’ in a ‘real-setting’. It demonstrated a major advance in the way we do clinical trials.
- 77 GP sites in Salford and Manchester took part in the study.
- 2,800 participants were recruited to the study within a seven month period.
“... As you can imagine, when we are looking to involve so many practices within a small geography, many had never been involved in delivering research before and needed a lot of support and encouragement.”
“The Network has been crucial in developing relationships with the practices, getting them on board, explaining what’s involved, providing Good Clinical Practice Training, and advising on the delivery of the study in this real-world setting. Without the support of the Clinical Research Network at a local level this study would never have happened.”
Dr Sue Collier, Head of Medical Operations - GSK
TWICS study
A randomised, double-blind placebo controlled trial of the effectiveness of low dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of COPD.
This novel study recruited over 1,500 participants from a primary care setting into an academic clinical trial of an investigational product.
This multisite study definitively showed that the addition of theophylline added no benefit to those patients with COPD on inhaled therapy.
Read more about this study at: www.nihr.ac.uk/twics
LIBERATE
The LIBERATE trial used novel treatment for Emphysema, a severe form of COPD and tested if the use of Endobronchial valves helped with lung function breathing tests and quality of life for participants . The one-way valves were placed into target areas of the lungs without the need for invasive surgery.
The valves caused the more damaged areas to deflate and the healthier areas of the lung to work more effectively. The study results, in combination with others, have led to the valves being used in more than 10 centres in the UK after recommendation by NICE.
LIBERATE was a randomised controlled trial, recruiting 190 participants at 23 clinical research sites across four countries. The NIHR CRN supported the study, recruiting 14 participants across two sites in England.