Welcome to our second blog. This month we are introducing you to the Trust’s Clinical Research Unit (CRU).
The CRU is embedded within the Royal Liverpool University Hospital and has been open since 2009. It currently consists of 12 beds and is primarily designed to support and conduct early phase academic and commercial clinical trials in patients and healthy volunteers.
In 2012, the unit was the first NHS organisation in England to achieve MHRA Phase 1 Accreditation which we have continued to maintain; we employ Principal Investigators who can conduct First in Human (FIH) Clinical Trials. FIH clinical trials are part of the exploratory phase of drug development. These trials are relatively small, typically having 20-80 subjects.
The safety of our participants is paramount and all of our clinical staff regularly undertake Intermediate Life Support training and keep their clinical skills updated in line with NHS guidelines. Being embedded in the hospital provides direct access to 24 hour emergency coverage (including ITU).
As a relatively new CRU, it continues to build on its excellent track record year on year. For example the number of overnight stays in 2016 was almost three times that seen in the previous 12 months. Along with the overnight stays, the intensity of the studies has also increased as a result of us moving away from ‘later phase’ clinical trials and conducting much more ‘early phase’ work in a variety of disease areas. In order to support this increased workload, the CRU is now fully staffed including some bespoke positions such as Recruitment Management and Project Management which are already proving as valuable additions. These positions join our Senior Management, Physicians, Data Management, Laboratory Team and Nursing Teams to provide an efficient and effective service to our clients and volunteers.
In order to assist in effective and efficient recruitment the CRU manages the Trust’s validated database of volunteers (Consent 4 Consent), consisting of both healthy and patient populations. With direct links to clinics within the hospital, primary and community care settings, and recruitment staff working within such settings, these numbers are constantly growing. The database can be used to quickly extract metric and contact information of potential participants and to produce reports about the feasibility for potential trials.
Like other services we are passionate about continuous improvement and request and respond to feedback from our participants (and more recently our clients). Last month we received the following letter from a participant and his wife following their experience of the CRU:
“M and I would like to say what a pleasure it has been over the last 17 months to take part in the research programme. You have all been so very kind and thoughtful looking after M and myself on our visits to the unit. We are going to miss you all. Good luck for the future and the results of all your hard work”.
Are current trial portfolio includes clinical trials into potential new medicines for Alzheimer’s disease, asthma, osteoarthritis, psoriasis and cancer. Although we conduct clinical trials in a wide variety of disease areas, we have a number of areas that we will be focusing on one over the next few years:
- Inflammatory conditions with a focus on nephrology
- Neurodegenerative diseases
- Pancreatic and digestive diseases
In 2018 the new Royal Liverpool Hospital will be opened and will contain a purpose built, state of the art, 26 bed CRU to support the continued growth of Early Phase Clinical Trials and Experimental Medicine within the region as well as internationally.
If you would like to learn more about our Clinical Research Unit you can visit our website at www.clinicalresearchliverpool.nhs.uk.
Stay tuned for next month’s blog where we will have a guest blogger talking about the work they are doing in respiratory research!