Research at SWFT

Research could not happen without the support of patients, carers and members of the public. Your help to assist us improve services is vital, both for the present and future generations. Each year about 750 new patients take part in our studies and we currently have approximately 40 studies open.

Taking part in a trial may include any of the following:

• Talking to researchers
• Completing questionnaires
• Letting us take blood samples or other measurements e.g. blood pressure, urine tests
• Taking a new medicine or trying a new treatment

Why take part?

• You may benefit from a new treatment or test or others may benefit in the future
• You may want to contribute to improving care for others
• You may feel that you like the extra attention and time that sometimes participation in a trial can provide.
• You may want to increase your knowledge about your condition.

Research Studies

Research Studies that we are currently involved in include the following specialities:

• Diabetes
• Critical Care
• Cancer and haematology
• Heart disease
• Surgery
• Midwifery
• Emergency Medicine
• Gastroenterology
• Trauma and Orthopaedics
• Paediatrics
• Rheumatology

We support clinicians to open studies and actively seek to open studies in new specialities. Participation as a patient is voluntary and patients who do not wish to participate will still receive the best care that we can offer.

All research conducted within the Trust has been reviewed by the Research Governance department within the Research and Development team, to ensure robust standards are maintained.

Performance

You can see our performance here.

Should you wish to know more about the studies open to recruitment within any particular specialty please email research@swft.nhs.uk.

SWFT is one of the Partnership Trusts for the Comprehensive Research Network – West Midlands - https://local.nihr.ac.uk/lcrn/west-midlands

• To see if your idea is research, click here.
• For research planning, click here.
• For the approval process, click here.
• For roles and responsibilities, click here.

Please contact research@swft.nhs.uk for advice and guidance regarding Trust approval for Service Evaluations, Clinical and Educational Research.

SWFT Staff** When undertaking research, staff must adhere to the Trust's procedure in line with the Research Governance Framework.

GEH SWFT Knowledge and Library Service team are proud to help support colleagues undertaking research at both our NHS Trusts. Whether you are an experienced researcher or just starting the research project for your Apprenticeship, foundation degree or Masters, we are on site and online to help. The Research webpage on the library website is a good starting point but please don’t hesitate to contact any of our team. Here’s just some of the ways we can help:

• Information Skills training

We provide regular group sessions on how to plan and do an effective literature search. Visit our training webpages to view details of our next sessions. Our Clinical Librarians can also provide 1:1 advice on refining search strategies, database selection and signpost you to further reading to support your research. Contact us here

• Critical appraisal training

Why not book on one of our regular Critical Appraisal training sessions to develop or practise your skills in evaluating research? Click here for more information and future dates.

• Access to major research databases

Visit the NHS Knowledge and Library Service Hub where you can find links to clinical and health management databases and other useful resources such as the National Grey Literature Collection and Cochrane Library

• Current awareness

We can help you keep up to date in your area of research. Sign up here to receive personalised email bulletins from KnowledgeShare.

• Books for researchers

The Library collection includes books on all aspects of research from doing a literature or systematic review to critical appraisal and research methods. Search our regional library catalogue HeLM here.

• Article request service

Having trouble finding the full text of an article? Click here for handy search tips or complete our online request form

The NIHR Clinical Research Network (CRN) supports patients, the public and health and care organisations across England to participate in high-quality research, thereby advancing knowledge and improving care.

The CRN West Midlands (CRN WM) is the largest of 15 local Networks across England providing the infrastructure that allows high-quality research to take place in our area, so that people can benefit from new and better care and treatments.

The CRN WM help to increase opportunities for people to take part in research, ensure that studies are carried out efficiently and provide researchers with the practical support they need to carry out their research.

An up to date list of Portfolio trials recruiting across the country can be found via the link below. If you are interested in becoming a PI please contact the individual trial centres for further information.


Find Out More:

NIHR Website (https://www.nihr.ac.uk/explore-nihr/support/clinical-research-network.htm)
CRN West Midlands: (https://local.nihr.ac.uk/lcrn/west-midlands/)

Clinical Research Network Portfolio (https://www.nihr.ac.uk/researchers/collaborations-services-and-support-for-your-research/run-your-study/crn-portfolio.htm

Research Governance

Associate Medical Director of Research

Head of Research & Development

Email: Research@swft.nhs.uk Twitter: @Research_SWFT

Core Research

Senior Research Nurse

Email: Research.Nurses@swft.nhs.uk

Cancer Research

Rigby Lead Nurse – Cancer Research

Email: cancerresearch@swft.nhs.uk Twitter: @CancerWarwick

Family Health Research

Lead Research Midwife

Email: ResearchMidwife@swft.nhs.uk

The clinical benefit of undertaking cancer research includes access to the most novel and innovative cancer therapies. It has led to new drug treatments, a greater understanding of how to prevent cancer, new ways of delivering treatments and new surgical techniques. Cancer clinical trials are critical to advances in the understanding and treatment of cancer and to ensure patients have the opportunity to access world-class cancer treatments.

There is evidence to suggest that clinical research activity is a driver for high-quality cancer care with better outcomes for patients who are treated in research-intensive hospitals (National Institute for Health Research, 2014).

We have highlighted three of our current trials below:

TROPION-Breast02 is recruiting patients with previously untreated triple negative breast cancer (TNBC) that has spread (metastatic) or TNBC that has come back and cannot be removed. This international AstraZeneca Phase III study is assessing whether a new treatment, datopotamab deruxtecan (Dato-DXd), is better than current treatments. TNBC affects 1 in 5 women with breast cancer and is more common in women <40 and black women. It is the most aggressive type of breast cancer and cannot be treated with hormonal or targeted therapies. The outcome for patients with metastatic TNBC is usually worse than other types of breast cancer, with overall survival generally less than two years and five-year survival around 12%. Current treatment options may be poorly tolerated by patients and reduce quality of life. Dato-DXd is an antibody-drug conjugate, a treatment that can target breast cancer cells and deliver a drug that stops the cells growing. Warwick Hospital is offering the promising new treatment to patients across The Midlands.

Myeloma XV (RADAR) is recruiting patients newly diagnosed with Multiple Myeloma (MM) who are able to have a stem cell transplant. MM, also known as Myeloma, is a cancer that affects the bone marrow, spongy tissue found inside some bones that produces blood cells. Over 5,500 patients are diagnosed with MM each year in the UK. MM is an incurable relapsing-remitting cancer, meaning there are periods where the disease is active (relapsing) and requires treating, followed by periods where treatment may not be required (remitting). Significant progress has been made in developing new lines of treatment over the past 15 years. Newly diagnosed patients now survive on average 5-6 years, with 37% of men and 28% of women surviving 10 years. Currently all MM patients are given the same treatment, this UK-based Phase III study is investigating the personalisation of MM care. Some patients will have genetic markers that suggest their cancer will be more difficult to treat. These higher-risk patients, along with those whose cancer has not responded well to initial treatment, are offered more intensive therapy to extend the remitting period, while lower risk patients can receive reduced treatment with the aim of reducing side effects.

However, some women are at higher risk of becoming resistant to these treatments. Poetic-A is a phase III multicentre trial that assesses whether a new drug, abemaciclib, can be given to make treatment more effective than giving ET alone. This will aim to personalise care by looking at biological markers of risk, such as Ki67, to target treatment for women who are less responsive or resistant to ET and are therefore at higher risk of breast cancer coming back.

We are also recruiting to the following trials: COSMOS (Smouldering Myeloma), Cutaneous Tumour (Keratoacanthoma), Mithridate (Polycythemia vera), Nerlyfe (early-stage HR+/HER- breast cancer being treated with Neratinib), Rampart (Renal Cell Carcinoma), Rudy (AML), Stampede (Metastatic/Advancing Prostate Cancer), TransRampart (Renal Cell Carcinoma), UKGPCS (Prostate Cancer) and UKAITPR (Idiopathic Thrombocytopenic Purpura). For more information visit Be Part of Research or contact us directly.Oncology and Haematology Trials

BaBi Warwick will collect data from each woman who agrees to participate in the study to answer relevant research questions around our local population. This data will be kept secure and used only for research and service planning.

GBS3 trial is looking at whether testing pregnant women for Group B Streptococcus reduces the risk of infection in newborn babies compared to the current strategy in place in the UK. The current strategy in the UK is to offer antibiotics during labour to women who are considered at raised risk of their baby developing a group B Strep infection.

There are two different tests, which the study is comparing against the current strategy. Hospitals are randomly allocated to 1 of 3 groups:

• Lab Based Test at 3-5 weeks before anticipated delivery date (Enriched Culture Medium Testing)
• Bedside Test at start of labour (Intrapartum Rapid Testing)
• Risk Factor Based testing (Usual Care)

SWFT has been randomised to the Risk Factor Based testing group. This means no additional procedures (outside of the usual care) will be undertaken. Women will be treated for group B Strep in accordance with SWFT hospital policy and the current UK strategy.

The Giant PANDA Trial is looking at evaluating the effects of different antihypertensive drugs in women with pregnancy hypertension on maternal and foetal/neonatal outcomes.

The study is a randomised control trial, which means women who want to take part are randomised into one of two medication groups, both of which can be used to treat raised blood pressure in pregnancy.

The aim of the trial is to identify which is the most suitable medication to use, therefore the Research Midwife team at SWFT will follow the participant’s pregnancy and birth, providing anonymised data to the trial team. If the medication that the participant is randomised to isn’t working to treat their raised blood pressure, they can be reverted back to the alternative medication.

PETS is a randomised trial, and several hospital sites will provide elastic stockings to some patients undergoing short-stay surgery, and other hospitals will not provide stockings. Warwick Hospital is not providing stockings to some people who are eligible for the study. Patients will be approached on the day of their surgery.

If patients choose to be involved in the research, their participation will last 3-months from entry. They will be contacted at 7 and 90 days after their surgery to answer short questions about their health and see if they have developed a blood clot.

For more information please click here.

Both FREMS and TENS give electrical pulses delivered through stickers on the skin. The nature of these pulses is different between FREMS and TENS, resulting in different biological effects on pain and different responses (short term pain reductions for TENS, usually days, and 3-4 months for FREMS).

The study aims to evaluate the efficacy of FREMS (Frequency Rhythmic Electrical Modulated System) in patients with painful diabetic peripheral neuropathy (PDPN, painful feet from nerve damages caused by diabetes) who have not responded to the NICE (National Institute for Health and Care Excellence) recommended treatments. FREMS delivers electrical pulses via stickers that are placed on the feet and legs; these pulses can reduce the pain in patients with PDPN.

For more information visit: https://frems.digitrial.com

Perioperative Quality Improvement Programme (PQIP)

PQIP is a national research and quality improvement initiative which is looking at the perioperative care of patients having elective surgery. The aim is to investigate how these patients are treated, how they feel their care and recovery has been and if any complications have occurred. This data can then be used to improve patient care and ensure best practice is maintained throughout the whole country.

Here at Warwick Hospital, we have successfully recruited over 250 colorectal patients to the study.

For more information go to www.pqip.org.uk

OPTIMISE Study

Research Question: Can we predict which patients with Psoriatic Arthritis will respond to treatment using precision medicine?

This study is supporting patients with Psoriatic Arthritis who do not respond to standard arthritis drugs. There are two different types of biologic drugs available (Adalimumab and Secukinumab).

In patients taking either of these drugs about 50 % will find the drug relieves their symptoms, however importantly 50 % will not respond well. Trying each drug can take time and patients have to wait to see if another drug works.

We do not currently know how to predict in advance which patient will respond best to each drug. The study aim is to test whether we can predict, using blood tests, if people with Psoriatic Arthritis will respond to either biologic drug leading to a reduction in inflamed joints and pain.

The Surviving Crying project was created to support parents and carers who have babies up to five months old who cry for prolonged periods. Excessive crying affects one in five babies, with peak crying often happening around five weeks of age. This is sometimes known as infant ‘colic’, although it often has nothing to do with digestion or any physical illness.

The project team has developed a support package to help parents understand and cope with prolonged crying, which can be extremely traumatic for parents and carers. This includes written and online materials and a support programme provided by specially trained health visitors.

This trial aims to find out if our support package used in conjunction with standard health visits is more effective in helping parents and carers cope with an excessively crying baby than standard health visits alone.

Fast Track Faecal Calprotectin

Changes in bowel habits are common in the general population. The Fast Track Faecal Calprotectin Study aims to collect information from patients referred from primary care with fast track lower gastrointestinal symptoms, who have been recommended for further investigation of their bowel symptoms, or who are scheduled for routine bowel surveillance, such as a colonoscopy, a CT colonography, or a Colon Capsule Endoscopy (which is being piloted by the NHS) to compare the three different tests to see how effective they are at identifying bowel disease.

• Find out more about the National Institute for Health Research (NIHR).
• More information about what clinical trials are, why you should join, and what’s typically involved here.
• Be Part of Research allows users to search for opportunities to participate in research.
• An online resource where researchers and research organisations advertise opportunities for members of the public to get involved in research.