269 years ago the first ever clinical trial was carried out, looking into the link between vitamin C and scurvy. Since then clinical trials have developed into a vital tool for healthcare. To celebrate the importance of James Lind’s pioneering work, each year on May 20 International Clinical Trials Day is held.
Lind's experiments in 1747 were run under very different conditions to today. He was serving as a surgeon on HMS Salisbury. His trial consisted of just 12 men, grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons. The trial only lasted six days but, within that time, there was a noticeable improvement in the group eating the fruit, providing Lind with evidence of the link between citrus fruits and scurvy. Now almost 300 years after this breakthrough work, why is research in healthcare still so important and how does it benefit patients today?
A clinical trial is a type of clinical research that compares one treatment with another. It may involve patients or healthy people, or both. Small studies produce less reliable results than large ones, so studies often have to be carried out on a large number of people before the results are considered sufficiently reliable.
Doctors and other healthcare professionals and patients need evidence from clinical trials to know which treatments work best. Without this evidence, there is a risk that people could be given treatments that have no advantage, waste NHS resources, and might even be harmful.
Clinical trials help to find out if treatments are safe, if they have any side effects and if new treatments are better than the standard available treatments.
Professor Steve Bain, ABMU Health Board’s Assistant Medical Director (Research and Development), says International Clinical Trials Day is a great way to help people understand the importance of this type of research work.
Professor Bain said: “International Clinical Trials Day is a great opportunity to celebrate the crucial role of research and clinical trials to the NHS. From paracetamol and chemotherapy to treatments for depression and diabetes -without research, many of the treatments and types of care that we receive today just wouldn’t be available.
“And members of the public have an essential role to play, since without people agreeing to take part in research studies these improved treatments and care wouldn’t exist.”
And South West Wales’s reputation for clinical research excellence is growing through the ambitious aims of the ARCH Programme. ARCH (A Regional Collaboration for Health), is a unique partnership between Swansea University and ABMU and Hywel Dda health boards.
Through ARCH, there are plans to expand the clinical trials and research activity across the entire region of South West Wales. The Joint Clinical Research Facility (J-CRF), which is currently shared by Swansea University and ABMU health board, undertakes patient research and serves a population of 500,000. Through the ARCH partnership, this benefit will extend to almost 1 million people.
Professor Bain explains: “Through the ambitions of ARCH, our patients and staff can gain great benefits from an expanded clinical research environment. We have existing J-CRF activity at Singleton, Morriston and Prince Philip hospitals, but through the collaborative approach of ARCH, we now have plans to expand this activity across the entire region.
“The J-CRF provides an important platform for translation of research into clinical innovation for meaningful patient benefit. This expansion will all us to undertake a broader and much larger portfolio of projects ranging from pharmaceutical to medical device innovation.
“What makes the ARCH region special is its unusually stable population of around a million people, many with chronic illnesses which plague the modern world such as cancer, cardiovascular disease and diabetes. This combination is potentially a huge draw for research and development companies, meaning that as well as the benefits to the NHS, in terms of better availability of leading technologies and therapies, the expansion will boost economic growth through potential investment from industry partners.
“We will be able to maximise the potential of the 1 million ARCH population to position this region, and indeed Wales, as a leader in championing clinical research within the NHS.”
Professor Bain added that Swansea already has a good track record of working with new drugs for treating diabetes: “We already see ourselves as a leading centre and already attract work from global pharmaceutical companies. Hopefully, the development of ARCH will lead to an upscaling of our activities so we can become a major player in the global search for new medicines.
“Instead of a trial taking place in perhaps six centres around the UK, ARCH gives the opportunity to have them all in South West Wales. If it can be done in one area it will save time and money, and boost the whole economy.”
The J-CRF in Swansea was established in 1990 and has a team of highly trained research nursing staff and an excellent track record for recruitment and randomisation. Kathie Wareham, director of clinical research at J-CRF, said: “We are fortunate here in South West Wales to have vibrant research departments which allows our patients participate in the development of future medicines and devices.
“Clinical trials are not only income-generating for the health board and the university’s medical school, they save the NHS money because the medicines are provided free by the companies trying to license them. Having people on these trials also frees up places within hospitals so NHS patients can be treated more quickly.”
Dr Phil Kloer, Hywel Dda’s medical director and ARCH lead, explains how valuable this sort of work is to the NHS in terms of treatments but also how they can help people stay well without medical intervention. Dr Kloer said: “Clinical trials can help us learn how to prevent illnesses by testing a vaccine for example, detect or diagnose illnesses by testing a scan or blood test, treat illnesses by testing new or existing medicines, find out how best to provide psychological support and also importantly help find out how people can control their symptoms or improve their quality of life – for example, by testing how a particular diet or activity affects a condition.”
But Dr Kloer also stressed the rigorous protocols around clinical trials to ensure safety is paramount at all times: “Trials follow a set of rules, known as a protocol, to ensure they are well designed and as safe as possible, they measure the right things in the right way, and the results are meaningful. All trials are closely monitored.”
Clinical research is funded through a number of routes, Welsh Government funds research in Wales through Health and Care Research Wales and each health board has a budget for R&D. Dr Jon Bisson, director of Health and Care Research Wales, said Wales has a huge role to play in delivering clinical trials research.
Dr Bisson said: “Clinical Trials Units offer expertise in specialist trial design, conduct and analysis to researchers in Wales and beyond. They facilitate high-quality, timely and successful trial conduct and ensure regulatory and governance requirements are met.
“Through Health and Care Research Wales, the Welsh Government is investing in Clinical Trials Units including Swansea Trials Unit (STU). International Clinical Trials Day is a great way to showcase the work going on here in Wales.”
Swansea Trials Unit (STU), which is based at Swansea University’s Medical School on the Singleton Campus, works closely with researchers rather than the industry & patient facing work carried out at J-CRF. The Swansea unit has run nearly 40 trials valued at more than £20 million.
STU manager Gail Holland added: “We aim to improve the health of the people of South West Wales and beyond by enhancing the number, progress and quality of trials, with particular reference to secondary and emergency care.
“Thanks to funding from Health and Care Research Wales we are able to provide training to build capacity in clinical trials. We also offer advice and support for trial design, regulation, recruitment, data collection, management and analysis.”
Dr Bisson added: “We want more people to understand the value and importance of clinical trials and research and hopefully they will consider taking part. Without members of the public taking part in research, improvements to treatments and care cannot be made.
“By taking part in a research study, you could benefit future generations and play a really important role in medical progress.”
To find out more about clinical trials you can attend Health and Care Research Wales’s free event at Swansea’s Waterfront Museum on Friday, May 20 from 12pm to 2pm to mark International Clinical Trials Day.