Introduction to clinical trials
RCTs are widely regarded as the principal approach to obtain a reliable evaluation of the effectiveness of healthcare interventions, treatments and therapies. The design, implementation and analysis of these trials must be of the highest quality to ensure that the conclusions drawn from them are accurate. Keele Clinical Trials Unit has strong collaborations with clinical partners, and proven capacity and expertise in running pragmatic RCTs of complex interventions in a range of settings.
International Clinical Trials Day celebrates the anniversary of the first clinical trial conducted, in 1747 by Naval Surgeon James Lind on board the HMS Salisbury. Twelve men suffering from scurvy were grouped into pairs and given a variety of dietary supplements, as follows; 1.1 litres of cider; twenty-five millilitres of elixir vitriol (dilute sulphuric acid); 18 millilitres of vinegar three times throughout the day before meals; half a pint of seawater; two oranges and one lemon (continued for six days only when the supply was exhausted); and a medicinal paste made up of garlic, mustard seed, dried radish root and gum myrrh. Within six days Lind registered a noticeable improvement in the group eating the citrus fruits, providing him with the evidence required linking lack of citrus fruits (vitamin C) and the development of scurvy.
Clinical Research is vital to provide the evidence and ensure patients receive the optimum care and treatment that can be made available. On the 20th May 2020, we celebrate our achievements and take time out to be grateful to the participants and NHS staff who have helped us to achieve the improvements we have made within Primary Care. Please feel free to raise research with your GP, who will be aware of available recruiting studies for you to consider taking part in.
Visit our meet the team page to learn more about the team.
Here, Professor Gillian Lancaster provides some information on the benefits of clinical trials and Sarah Lawton explains a little more about who we are, where we are and what we do:
The 6 core functions of Keele CTU include;
Excellent Project Coordination is the key to successful trial delivery. The Trial Manager/Study Coordinator coordinates and is responsible for the day-to-day activities of a trial. Our successful trial managers/study coordinators are multitalented with good leadership skills, they are well organised with an ability to multi-task, capable of decision-making and are excellent communicators.
Our Trial Managers and Study Coordinators are members of the UK Trial Managers' Network. The aim of the network is to facilitate development, provide training and share best practice for trial managers and study coordinators who make an important contribution to the delivery of trials. For the latest news and updates from the UKTMN follow their Twitter account.
Our trial administrators work closely with the Trial Managers/Study Coordinators and support the whole trial team. The CTU has study administrators, customer service administrators and data management administrators. They have good communication skills and attention to detail.
Data Management & Software Development
The Data Manager ensures that all necessary data is collected in a timely manner by working closely with the Software Developer and project coordination team, to ensure that the database design will allow for the necessary prompts and reports to facilitate timely data collection. The Software Developer develops computer programs for trial data management, trial administration, analyses and for general trial monitoring systems. Please look here again on Wednesday, where you can find out more about the electronic data capture (EDC) innovations that Keele CTU are working on.
Take a look at this poster which will provide you with some ways in which Keele CTU use Health Informatics to enhance the conduct of research and improve recruitment and retention rates.
Statistics and Analysis
Our Statisticians are core members of a research study team. Their role is to ensure that an appropriate study methodology is selected, the sample size estimation is accurate, that the interim and final analyses mirror the outcomes in the protocol and that the analyses are conducted according to a Statistical Analysis Plan. The Statistician is committed and involved from the start of the trial.
In order to deliver a clinical trial to meet the trial objectives successfully, we ensure that our trials are conducted at the highest level of quality. We work closely with our Health and Social Care Standard Operating Procedures (SOPs) to do so: https://www.keele.ac.uk/research/raise/governanceintegrityandethics/
Keele CTU has established a number of Working Groups to: ensure that project management skills and knowledge are consistent; to evaluate risk and plan contingency; establish clear processes; coordinate resources; monitor progress and quality assurance; and to recognise where processes could be improved.
Research Design Service (RDS) West Midlands provides support to those preparing research proposals for submission to peer-reviewed funding competitions for applied health or social care research. Please visit their website.
Keele CTU have just started working on a newly awarded, £1.5 million research grant to help reduce sickness absence, see this link for more information.