A massive “thank you” is being issued to 3,457 patients and more than 200 staff, after South Tees Hospitals NHS Foundation Trust enjoyed a record year in Research & Development (R&D).
The year 2016 to 2017 became South Tees Hospitals NHS Foundation Trust’s most successful in R&D to date, as the Trust boasted a 17% increase in the number of patients taking part in clinical trials compared with the previous year.
The recruitment of 3,457 patients across 195 different research studies the Trust is currently involved with also put it at the leading edge of research compared with other hospital trusts across England, as it smashed the national average increase in patients accessing clinical trials.
The South Tees Trust, which boasts an Institute for Learning, Research and Innovation (LRI) on its James Cook University Hospital site, also recruited the very first patient to one global study and the first patient in five separate UK studies.
Dr Caroline Wroe, the Trust’s director of Research and Innovation, said: “In 2016/17 we increased the number of patients involved in Research by 17%, compared to a National Average of 10%.
“So we’d like to say a massive thank you to the thousands of patients and over 200 staff involved in clinical trials in 2016 to 2017.
“We’re grateful for the hard work and dedication of all our staff involved in Research and Development as well as the thousands of patients who took part in clinical trials last year.
“Without them, our participation in research into new treatments that could benefit future patients for years to come would not be possible.”
The 195 trials South Tees took part in during the last financial year include the Mini Mitral trial, comparing the gold standard sternotomy (or open heart) procedure for treating a leaky heart valve with a keyhole technique, and the STAMPEDE Trial, which is investigating different drug treatments to prevent prostate tumour regrowth.
The trust has also recruited 44 women to the PRE-EMPT trial, looking at treatments for women with potentially debilitating and fertility-threatening endometriosis, while the Checkmate 227 trial, led by James Cook oncologists Dr Talal Mansy and Dr Louise Li is looking into new lung cancer treatments.
James Cook is one of just 10 centres in the world taking part in the global Checkmate 227 study, investigating the potential benefits of combining two immunotherapy drugs or immunotherapy with chemotherapy for lung cancer patients.
Another highlight for the year included the cardiothoracic team at James Cook, led by Dr Mark de Belder, being commended by the New York University-based leaders of the ISCHEMIA trial, set up to determine the best way to manage stable ischemic heart disease, for the high quality of its data and for being of the top recruiting teams in the UK.
R&D staff from across South Tees joined the National Institute of Health Research’s (NIHR) #IAmResearch campaign, celebrating their year of success as part of International Clinical Trials Day.
Staff shared the unique reasons they find research so rewarding on Twitter @SouthTees.
For more information on R&D at South Tees, visit https://www.southteeslri.co.uk/research-and-development
More on some of our Trials from 2016/2017
The National Institute for Health Research (NIHR) funded STAMPEDE Trial, is investigating new drug treatments for Prostate Cancer patients.
Most men with prostate cancer are given hormone therapy. This is often effective for a short time at stopping the tumour growing.
However in most cases over time the tumour will start to grow again. The aim of the STAMPEDE trial is to try to prevent the tumour re-growth by adding other treatment to the hormone therapy. The trial is currently using a drug called metformin in combination with hormone therapy.
Ken Bashford, 60, from New Marske, is one of the trust’s STAMPEDE patients. Speaking of his involvement in research, Ken says he “feels reassured” by the fact his condition is so closely monitored on the trial.
Ken was offered the opportunity to go on the trial after learning his prostate cancer was incurable, but containable and after he had already started having hormone therapy injections of Degarelix in his stomach.
The injections caused his stomach to swell “like a rugby ball” and caused pain and tiredness – but the treatment worked, as his PSA levels gradually came down.
After starting the additional hormone treatment as part of the STAMPEDE trial, he also began taking four Abiraterone Acetate tablets, followed by 160mg of Enzalutamide after breakfast – and a steroid tablet every day.
This doesn’t bother him too much now he is in the routine of taking them, but he began to dread the monthly injections in the stomach and has since switched to a three-monthly implant.
Thankfully, this combination seems to be working well for him at the present time and he says he is happy to be able to be involved in a clinical trial at the same time as raising awareness about Prostate Cancer.
He is looking forward to taking part in Sports TV celebrity Jeff Stelling’s Prostate Cancer march when it reaches the Riverside Stadium in Middlesbrough later this month.
Ken said: “The way I look at it is that this trial could help provide a cure for patients in future.”
Find out more on Ken’s story here.
THE PRE-EMPT TRIAL
The PRE-EMPT trial aims to discover the most suitable treatment options for women with endometriosis.
This is a painful and potentially debilitating condition, which can also lead to infertility and affect women’s emotional health and wellbeing, social lives, relationships and careers.
Cells similar to those within the lining of the womb are found in abnormal locations elsewhere in the body, commonly within the pelvis, such as the ovary, bowel or bladder – although they can also migrate further.
This causes lesions and scar tissue and internal bleeding within the body, leading to a range of painful and potentially embarrassing symptoms.
James Cook research nurse Helen Cuthbert is leading the recruitment of women with endometriosis at South Tees to the trial.
The Trust has now reached its recruitment target, with 44 patients with endometriosis now taking part in the trial at South Tees.
Helen, who has been a research nurse for just one year, says she finds the role hugely rewarding.
She says: “It’s really positive to be involved in research that could be hugely beneficial to women with endometriosis, which can be debilitating and can also affect fertility.
“According to our endometriosis specialist nurse, we have seen women in their thirties having hysterectomies as a result of the condition.
“There is a lot still to discover about the condition as there is no definitive treatment, but this study is looking at three different options for women with endometriosis.”
The randomised controlled clinical trial sees women who are undergoing surgery for endometriosis randomly allocated to take long acting progestogens, which are also used as forms of contraception. The trial is looking at three monthly depo provera injection, an intra-uterine device (coil), or long term treatment with the oral contraceptive pill as possible methods of treatment for the condition.
The trial will provide information on which treatment is the most effective in terms of symptom relief, side-effects, acceptability and costs. This information will be vital in terms of future clinical decision making in an area of uncertainty.
More information about the trial can be found on the University of Birmingham website.
Helen was a nurse at the Trust for 14 years before moving into research and is glad she made the move to such a rewarding role, which sees her act as a link between the more scientific elements of research and providing high quality care to patients taking part.
“My interest has always been women’s health so after a move to surgical admissions, it felt like coming home,” she explained.
“I think people have misconceptions about what being involved in research is all about. People think it’s all about statistics, but our role as research nurses is patient-facing.
“It’s great to be involved in research that could potentially transform your patient’s life and see them benefiting from that.”
The trial finishes later this year and results will be expected after that.
James Cook is one of ten centres taking part in this global research project to investigate the benefits of combining two immunotherapy drugs or immunotherapy with chemotherapy for lung cancer patients.
Medical oncologists Dr Talal Mansy and Dr Louise Li worked with a number of teams to bring the trial to James Cook including trials officers, the R&D department, histopathology, radiology, nuclear medicine, pharmacy, the chemotherapy day unit and schedulers – a real team effort!
Lung cancer still has some of the lowest survival rates of all cancers, but progress is slowly being made to try to improve patient outcomes.
Immunotherapy drugs are an exciting part of ongoing research as they “switch on the immune system” to fight cancer. Research is showing they are more effective and less toxic than chemotherapy for patients who have already had chemotherapy and have discovered their tumour is growing again.
The three key areas of the trial aim to determine whether:
- Immunotherapy is more effective treating patients in the first line setting (patients who have not received any treatment for their lung cancer so far)
- Combining immunotherapy with chemotherapy results in an even greater benefit
- Combining two immunotherapy drugs together will increase any patient benefit even further
THE ISCHEMIA TRIAL
Cardiologists were praised for their role in a major international study looking at the effectiveness of different treatments for patients with Ischemic Heart Disease.
The cardiothoracic team, led by Dr Mark de Belder, were commended by the New York University-based leaders of the ISCHEMIA trial, which has been set up to determine the best way to manage stable ischemic heart disease, for the high quality of the data submitted and being of the top recruiting teams in the UK.
THE MINI MITRAL TRIAL
The Cardiothoracic Team received £1.6m NHS funding as the leading clinical centre for the largest study of its kind in the world, comparing a highly invasive sternotomy procedure, in which the breast bone or sternum is prised open, with a keyhole technique.
The sternotomy is the current gold standard treatment option for patients suffering from ‘leaky’ heart valves or ‘mitral valve regurgitation’ – which can lead to heart failure requiring open heart surgery when it can no longer be managed by medication.
Patients’ symptoms range from shortness of breath and fainting, dizziness or tiredness to chest pains and faster than normal pulse rates.
The ongoing research will see half of patients having the conventional and gold-standard sternotomy, while the other 50% are operated on using a keyhole technique in the right hand side of the ribcage below the breast area. The research will look at whether this “less invasive” technique will deliver the same treatment results as the current gold standard sternotomy and compare the risks and benefits of both options.
The James Cook University Hospital has been using this technique for a number of years, but the trial, which will involve 400 patients across a number of hospital sites, will follow the patients taking part in detail for more than four years after their surgery, to assess whether there is a difference in patients’ recovery and subsequent health.
It will also look at whether there are any cost benefits to the newer technique.
The UK Mini Mitral Trial is being run by Durham University Clinical trials Unit, including academics from Newcastle University, with the Trust’s Consultant Cardiothoracic Surgeon Mr Enoch Akowuah as the chief investigator and surgeon Andrew Goodwin also involved.