Introduction to clinical trials

History of clinical trials

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.

Our core functions

Project Coordination

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.

Administration

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.

Health Informatics

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.

Quality Assurance

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

Keele CTU is a partner of the NIHR Research Support Service (RSS) Hub delivered by the University of Birmingham and Partners.

The RSS provides support and advice to researchers developing funding applications and at all stages of the research pathway - from pre-application through to post-award support through collaboration with our CTUs. The service is delivered by eight ‘Hubs’, each a partnership of research groups, organisations and clinical trials units (CTUs) with expertise in applied health and care research (Birmingham, Imperial, Kings, Lancaster, Leicester, Newcastle, Southampton, York). There are Specialist Centres for Social Care - Lancaster and for Public Health – Newcastle and Southampton. The RSS is a national service, and each hub and Specialist Centre is open to researchers based anywhere in England. The RSS can support researchers in the devolved nations if they are working in collaboration with English partners. Please visit the RSS website for more information about the service and Hubs offerings - https://www.nihr.ac.uk/explore-nihr/support/research-support-service/.

Collaboration and contact details

If you would like to collaborate with Keele CTU or discuss any research ideas, please complete the CTU Collaboration Request Form or please email ctu.operations@keele.ac.uk.