International Clinical Trials Day is an annual event acknowledged around the world to commemorate what is thought to be ‘the first ever’ clinical trial which was conducted in 1747 by Naval Surgeon, James Lind aboard HMS Salisbury.
Covid-19 trials and the clinical teams working on them
Research nurses, midwives, practitioners and the pharmacy clinical trials team across Royal Derby Hospital and Queen's Hospital Burton, along with the pharmacy clinical trials team have joined the battle to find out more information and look for a treatment for Covid-19.
Since the pandemic began the research teams across the Trust have focussed resources on implementing and supporting Covid-19 studies. The Trust is part of national and international teams of researchers working to develop new investigations into treatments and to build and share our knowledge of this virus.
We have a team of research nurses, midwives and practitioners at both Royal Derby and Queen's Hospital who are working with clinicians and other specialist colleagues to recruit people into the Covid-19 trials running at UHDB.
How to get involved in clinical research
The Research and Development teams at UHDB are at present focussing on Covid-19 trials and also on the many patients who are currently recruited to a vast array of existing non Covid-19 trials.
However, in the near future, we are hoping to return to inviting new patients to join clinical trials, as well as starting to set up new clinical trials which are not about Covid-19.
Getting involved in research doesn’t always mean becoming a patient participant though, there are other ways that you can help.
Clinical research myth buster
Clinical research is strictly regulated by the MHRA (Medicines and Healthcare products Regulatory Authority) and the Health Research Authority (HRA) and must adhere to guidance set out in the UK Policy Framework for Health and Social Care Research. This is not only to protect patients’ welfare but also to produce trusted evidence at the end of each trial. Many research studies impact on the introduction of new treatments including medicines and medical devices, which can benefit patient care now and in the future.
There are many myths about clinical trials. Here are some of the most common ones:
Research is experimentation on patients
Clinical research is about finding what works best in patient care in specific areas through a ‘clinical research study’. Each study aims to answer a specific question about patient care with the use of a carefully designed method. Patients participate in studies after they have gone through carefully regulated ‘informed consent’ procedures and the main reason commonly stated for volunteering to take part is because of the importance of improving knowledge and treatments. This collaborative decision-making process is an ethical and legal obligation of healthcare providers. A 2018 survey of 8,500 patient research participants showed that 88% of patients who took part in a research project at UHDB volunteered so that they could help future generations, 46% to improve their own or their child’s health and 38% to access new treatments not otherwise available in routine care.
Research in the NHS is a luxury, not a priority
Providing everyone in the NHS with the correct care and treatment is a priority, and as this is only achieved through research then research is a priority. Everyone providing care in the NHS uses research but not everyone is aware of it. The core of all good training is that it is based on evidence which can be trusted.
Research costs the NHS and takes away resources from patient care
There is much evidence to show that patients in research active hospitals have lower mortality rates so rather than taking away resources, clinical research activity in the NHS improves patient outcomes. Research in the NHS is not funded by the NHS itself but rather by charity, educational facility or commercial organisations and in some cases, clinical research is cost neutral or even a source of revenue for the NHS.
Patients refusing to participate in clinical research receive a poor level of care
Whether a patient agrees to participate in a research study or not, the patients’ standard of care will NEVER be compromised because of that decision. As part of a research study patients may find that their condition is more closely monitored but this is in addition to receiving their usual standard of care. This is due to the additional information that has to be collected and recorded to provide reliable results.
Research happens in a lab, not within the NHS
The majority of clinical research activity in the UK takes place in the NHS. The NIHR have stated that over 850,000 people participated in NHS related research during 2018/19. Research can help to identify effective and cost efficient treatments, processes and systems that can be used in healthcare.
Research is always funded by commercial companies who only want to make money
According to information from the NIHR, the vast majority of new medicines and medical devices that have come out in the last 50 years, have been made possible from research funded by ‘high revenue’ companies. This would not have been affordable through public funds alone. However, research in the UK NHS is carefully regulated to focus on patient benefit and there are many examples of jointly funded studies between commercial, charity and public sources where the benefits within healthcare are very apparent.
The first ever clinical trial - on this day in 1747
James Lind was a naval Surgeon on HMS Salisbury. During his time at sea in 1747, many of the crew were experiencing symptoms of scurvy for which there was no cure. Lind decided to investigate the cause of the illness.
On 20 May of that year, he selected 12 men to help with this investigation, all of whom had symptoms of scurvy. In addition, these 12 men had similar basic diets and were also sharing the same living quarters. Lind then divided the group of 12 into six pairs and over the course of 14 days gave them a variety of additions to their basic diet.
One pair of men drank cider, a second pair was given spoonful’s of vinegar, the next two had oranges and lemons, another pair ingested sea water, a further pair had diluted sulphuric acid, and the last pair was given a paste of mustard seeds, garlic, radish root and myrrh. The two men who consumed citrus fruits showed enough improvement within six days that they were deemed well enough to return to their duties.
As a result of this trial, albeit over 40 years later, an admiralty order ruled that all naval ships had to be stocked with lemon juice before they went on their voyages.