Ear Nose and Throat Specialty Profile
Why you should deliver ear nose and throat research in the UK
The Clinical Research Network (CRN) provides researchers with the practical support they need to make research happen in the NHS and the wider health and social care environment. As well as providing research delivery staff, we also bring together communities of clinical practice to provide national networks of research expertise. The Ear, Nose and Throat (ENT) Specialty is one of 30 such communities and is made up of leading research-interested ENT surgeons, audiologists, audiovestibular physicians and speech and language therapists operating at both national and local levels. Our job is to ensure that the ENT, hearing and balance studies we support are delivered to time and target.
Our specialty covers all conditions of the ears, nose and throat, including hearing and balance. ENT problems impact upon important daily functions including communication, breathing, swallowing, smell and taste. However rare or common these conditions are, they span the age spectrum, from newborns to the elderly. Research areas of focus in ENT have included hearing, tinnitus, balance, allergies, infections, and head and neck cancers. As such, we work closely with health care professionals in the community and primary care and with clinicians in related fields such as neurology, old age psychiatry, oncology, paediatrics, allergy and respiratory medicine.
We support and oversee a wide range of studies; from single-centre early stage evaluation of a medical technology or drug therapy, through to larger multicentre observational studies and randomised controlled trials of medical and surgical interventions. Current industry-led ENT trials on the NIHR CRN Portfolio include those testing novel auditory devices and drugs for the treatment of hearing loss, tinnitus and Ménière’s disease, and biologicals to treat nasal polyps. We can provide the following support:
Our membership consists of a UK-wide network of research active clinicians experienced in the efficient delivery of high quality studies in all areas related to ENT, hearing and balance disorders.
Access to patients
Over 3,700 participants across England were recruited into 54 ENT research studies in 2018/19. We can support study teams and commercial partners with access to a range of patient populations.
Throughout our portfolio of studies we work closely with patients and members of the public to ensure our research is patient-centred and we connect with hard-to-reach patient groups and those with rare diseases.
We can provide advice and guidance on recruitment strategies and approaches to overcoming potential barriers to successful study delivery.
Collaboration with other clinical specialties is integral to the service delivery and research into ENT, hearing and balance problems.
The ENT Specialty works closely with other NIHR CRN specialties, such as Children, Mental Health, Primary Care, Cancer, Dementias and Neuro-degeneration.
This helps to maximise opportunities for recruitment of study participants, as well as providing access to the support and expertise of other specialties.
ENT research is undertaken not only by ENT clinicians and audiovestibular physicians, but also allied health professionals such as audiologists, respiratory physiotherapists, speech and language therapists, and research nurses. The NIHR CRN can help you to access the most appropriate professionals to carry out your trial.
Regional teams have been developed which include ENT, hearing and balance research staff specifically trained in the recruitment and retention of study participants. These efforts ensure that ENT studies on the NIHR CRN Portfolio are consistently delivered successfully.
Over 75 per cent of ENT studies we have supported in the last 3 years successfully reached their target number of participants within their specified timeframes.
REGAIN: open-label safety and efficacy study of the Notch inhibitor LY3056480 in patients with mild to moderate sensorineural hearing loss.
Hearing loss affects 1 in 6 people in the UK, and it is estimated that half a billion people are affected worldwide. Sensorineural hearing loss is the most common cause of hearing loss in adults, which can be caused by damage to the hair cells lining the inner ear that has long been considered irreversible.
REGAIN is a Phase I/II study that is looking at assessing the safety, tolerability and efficacy of the Notch inhibitor LY3056480, a compound thought to help regenerate hearing in adults with sensorineural hearing loss.
REGAIN opened for recruitment in 2017, with the aim of recruiting 30 participants from across England.
The Chief Investigator Anne Schilder shared:
“With support of the NIHR and clinicians from across the UK referring patients interested in taking part to the Royal National Throat Nose and Ear Hospital in London, we were able to successfully deliver the phase I trial and are well on our way to complete the phase II trial to time and target.”
Baha 5 SuperPower Sound Processor on the Baha Attract System
Surgically implanted bone conduction hearing devices build on the body’s natural ability to transfer sound. They are offered to patients with certain types of hearing loss who cannot wear ‘in the ear’ or ‘behind the ear’ hearing aids.
The aim of this study was to evaluate the hearing
performance with a new and more powerful sound processor for the Cochlear Baha Attract System. This Baha 5 SuperPower sound processor is designed for people with higher degrees of hearing loss and is engineered to make difficult hearing situations easier.
The NIHR supported the delivery of the study which recruited six participants from one site. It also achieved the status of recruiting the first global patient - a key performance indicator for the life-sciences industry, demonstrating which countries can support the rapid set-up of studies.
The NIHR provided a range of support from portfolio adoption to funding for research staff and publicity of the study to aid recruitment.
The study has recently closed and initial study results are positive, showing participants felt the new sound processor improved their ability to hear.