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Pragmatic Clinical Trials Unit

Our Clinical Strengths

The PCTU is a thriving and dynamic clinical trials unit supporting high quality research across many different clinical areas with particular strengths in primary care, bone and joint health, critical care, surgery, and psychiatry.

Follow the links below to find out more.

Primary Care

High quality trials in primary and community care are important – 90% of patient contact with the NHS happens in primary care and over the past few years the structure, organisation and workforce in primary care have all changed dramatically. The PCTU has both breadth and depth in expertise supporting trials in primary and community care in this changing environment. These trials almost always involve complex behavioural interventions. The settings and focus of currently supported trials vary. Current examples include: community pharmacy (STOP – smoking cessation), primary care and community services for patients with multi-morbidity (TANDEM – COPD with co-morbid anxiety or depression), and tackling the health consequences associated with deprivation (SWAP – peer support for weight management in deprived communities). All our trials in primary and community care address significant, major health problems for the NHS and the UK.  

Bone and Joint Health

Bone & Joint Health formed in August 2020 supported by the Barts and the London Charity and soon after became a PCTU affiliated research group. Our purpose is to transform research, education and care for people with bone & joint disorders.  Our vision is to become global leaders in bone & joint disorders and injuries. We recognise the need to bring together all aspects of orthopaedics to ensure that we provide our patients with the best possible care.

We work jointly with both our home institutions, Barts Health NHS Trust and Barts and the London School of Medicine & Dentistry at Queen Mary University London. 

Professor Xavier Griffin, Chair of Bone & Joint Health, is driven by having meaningful impact on patient care; his research is focused on the clinical and cost effectiveness of new and existing treatments to improve bone and joint health. He has a passion for developing methodologies which harness the speed, power and efficiency of routinely collected data but are coupled with the great advantages of randomisation.

PCTU supported studies

We are currently collaborating with PCTU on a number of exciting new studies with funding grants in development.

Key staff:

Xavier Griffin, Chair of Bone & Joint Health
Lauren Exell, Executive Assistant to Professor Xavier Griffin
Jamila Kassam, Academic Strategic Lead

Critical Care and Perioperative Medicine

Having collaborated with Critical Care and Perioperative Medicine Research Group (CCPMG) for over 5 years, in 2018, the PCTU proudly welcomed the CCPMG as the fifth official affiliate research group. This follows several successful perioperative research projects, including EPOCH and OPTIMISE II, with many more projects currently in set up with the PCTU. This latest collaboration marks the CCPMG as the fifth affiliated research group with the PCTU.

The CCPMG is led by Professor Rupert Pearse, NIHR Research Professor & Consultant in Intensive Care Medicine, who completed his fellowship with the PCTU and has been lead CI on a number of collaborations with the PCTU. The research group is based at the Royal London Hospital, and is also a part of the William Harvey Research Institute. The CCPMG is composed of a multidisciplinary team, including lecturers, research managers, research and clinical nurses, fellows, and assistants. Statistical resources are also shared between the PCTU and CCPMG. Priyanthi Dias and Ruzena Uddin are the senior research managers acting as the main contact between the PCTU and CCPMG.

Colorectal Surgery

A strong relationship has developed between investigators in the National Bowel Research Centre (NBRC), led by Prof Charles Knowles, and PCTU. This relationship has been built over the last 5 years based on the successful delivery of several NIHR funded RCTs including the CONFIDeNT study of percutaneous tibial nerve stimulation for adults with faecal incontinence (FI) [Knowles et al., Lancet 2016]. An ongoing portfolio of 3 national and 1 international (UK/EU) RCTs have led to this cooperation being formalised into a service level agreement between NBRC and PCTU to aid development of further new studies, including senior in house statistical support. The NBRC and PCTU share a vision that complex interventions for common colorectal conditions (and indeed more general surgical problems) could be much better evaluated by new methodological approaches, including improvements to observational studies. This drive has already led to collaborative bids for methodological funding. A team has been developed on this basis that includes a senior research programme manager (Shiva Taveri) as well as new NIHR faculty (lecturer and ACF).

 

Psychiatry

A major strength of the PCTU is the evaluation of complex interventions in mental health care. This includes completed trials on innovative interventions such as body psychotherapy in the treatment of negative symptoms of schizophrenia, using financial incentives to improve adherence to medication, and testing the DIALOG+ intervention in community care and forensic settings. Ongoing work includes feasibility and full trials on effects of support housing, new interventions to improve patients' quality of life through enhancing their social networks, testing DIALOG+ in patients with chronic depression, and evaluating the effects of peer support. 

Most of the studies require complex designs that are challenging to implement. The PCTU has an especially positive track record in completing these studies successfully.

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