What is clinical research?

It is essential to improve our understanding of how new medicines and technologies can be developed to help in the fight against diseases such as cancer, heart disease, arthritis and diabetes. Scientists in laboratories across the world are tirelessly working to unlock the key to fighting disease by studying the basic mechanisms underpinning life and by doing this are able to create new medicines and techniques. However, these need to be tested in real people to make sure they are effective, and any side effects are kept to a minimum. This is called clinical research.

Clinical research seeks to address two fundamental questions:

• Does a new treatment work in people living with a particular disease? Is the new treatment more effective than existing treatments? Does it have fewer side effects than existing treatments? Is the new treatment a step forward in the treatment of the disease?
• Is a new treatment safe? This is a vital aspect of research. If a new treatment is effective against a disease, it must also be safe to use in people. Assessments of safety represent a very significant component of clinical research.

Without clinical trials new treatments cannot be developed.

Is research safe?

All trials are governed by strict, legally enforced regulations. Before they go ahead, they undergo close scrutiny by an ethics committee. All research staff receive dedicated training about clinical research called ‘Good Clinical Practise’. In this way, patients’ safety, wellbeing and rights are consistently maintained.

Medical professionals only include patients in studies who meet detailed criteria for being included on the study (see below) and continuously monitor their safety throughout. Through these channels, risk to patients is kept to a minimum.

How do I benefit from participating in clinical research?

If you enter a trial, there is a possibility that you will receive the latest treatment and this treatment might prove to be more effective than the ‘standard’ care. However, if the trial is testing a new treatment it is often necessary for the doctors to compare the treatment with the ‘standard’ care, and this means you might not receive the new treatment. You should note that you cannot choose which treatment to receive. Whichever treatment you are given, in research you will receive a high level of attention from our clinical staff, and many patients find this attention to be reassuring.

How is clinical research managed in the NHS?

Before a trial can recruit volunteers and start it must have in place a detailed blueprint known as a ‘protocol’. The protocol is compiled by many leading experts in the field and is carefully scrutinised by an independent ethics committee to ensure the safety, rights and wellbeing of study participants come first and are protected at all times. This protocol will let you know the healthcare professionals responsible for the various study activities; the number and medical status of participants required at the outset; the precise treatment you will receive; medical tests and assessments.

Can I be paid for being in a research study?

Patients who participate in certain studies receive reasonable travel expenses and refreshments.

Can I withdraw from a research study?

Participation in clinical research is entirely voluntary. Anyone taking part in a study can withdraw at any time without giving a reason. Withdrawing from a study or a decision not to take part in a study will not affect the quality of care you will receive.

What should I consider when joining a research study?

You will have a hospital appointment where we will determine your suitability to join a trial and will provide you with enough information to decide whether joining the study is the right choice for you. This information will include written material which you can study at leisure. You will be told about any possible risks as well as potential side effects. You will also be given the opportunity to ask any questions you have about the trial. Some issues you might like to raise are:

• what is the purpose of the study?
• why am I being considered and approached for the study?
• how many other people have undergone this new type of treatment so far?
• how long will the study last?
• who can I talk to if I have any questions?
• how many appointments will I have at the hospital?
• what restrictions are there on what I can do while in the study?
• what will happen to any of my samples or information collected during the study
• what happens if my illness becomes worse?
• what happens if something goes wrong?

Will my information be kept confidential?

A clinical trial could involve the activities of a range of medical professionals which means that more people than just your doctor will need to see your medical information. However, your confidentiality is assured by the Data Protection Act. On some occasions your data will need to be shared with other hospital sites, and in this instance, steps are taken to anonymise your details. And, of course, when doctors publish the findings of a trial, they are not allowed to include your name unless they have specifically obtained ethical approval for this purpose and you have given explicit consent.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer (This email address is being protected from spambots. You need JavaScript enabled to view it.) who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can contact the Information Commissioner’s Office (ICO) (Contact us | ICO).

How do I enquire about taking part in research?

If you are a UHD patient, you can query with your doctor or nurse whether there are any research studies with which you could become involved. Alternatively, you can contact the Rand D central team directly by emailing This email address is being protected from spambots. You need JavaScript enabled to view it..

You can also visit the Be Part of Research website (https://bepartofresearch.nihr.ac.uk/) for information about what research is currently happening across the UK and what it might mean to take part.

Patient and Public Involvement (PPI) in Research

Patient and Public Involvement (PPI) with research can be done in different ways. Examples include:

• Encouraging members of the public to join advisory groups supporting research
• Reviewing grant proposals and research methodologies
• Contributing as active partners in research
• Helping with data collection or analysis

UHD is among other research organisations who are looking for patients and members of the public to get involved in research and our researchers are encouraged to seek patient and public involvement at each stage in the research process. To see if there are any PPI opportunities in your area you can visit the People in Research website (Home - People in Research).

Since the merger of Poole Hospital NHS Foundation Trust and Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust in October 2020, at any one time there are approximately 400 studies taking place at the trust.

COVID-19

The impact of Covid had significant changes to everyone involved in research, both in the way staff worked and how the participants were recruited and seen in follow-up. As the world shut down the scientists and doctors turned to research to try to identify ways we could emerge safely from Covid. The race was on to identify potential vaccines to protect the population, and also to identify potential treatments for the surge in very sick patients admitted into our hospitals.

UHD’s research team had to rapidly adapt to work in this new environment and were privileged to be involved in a number of pivotal clinical trials. One of the most significant trials for Covid in the UK and the world, was the RECOVERY trial, the results of which demonstrated the most effective treatment options available for doctors treating patients with Covid. The research teams working on RECOVERY left their normal clinical speciality and came together, adapting quickly to utilise their skills and experience in the new world of Covid research. The team up-skilled to meet the demands of the trial, and to be able to administer study treatments such as convalescent plasma and monoclonal antibodies to patients on the wards. One of the most positive outcomes of working on RECOVERY was the teamwork between the research teams and the ward staff, resulting in research being seen as a normal part of the care we can offer our patients.

In October 2020, nine months after Covid had emerged, the Dorset Research Hub (now Dorset Clinical Research Centre), was set up as a vaccine research hub to offer residents in Dorset the opportunity to take part in Covid vaccine research trials. This was a great example of collaboration, working closely with Southampton University Hospital and The Adam Practice to offer our local population access to research. The first Covid vaccine study, NOVAVAX, recruited over 640 participants in 7 weeks. Since then the uub has been involved in a further seven vaccine studies, including booster studies, with over 1,100 participants taking part.

The team were immensely proud to be involved in delivery these studies and have been recognised in Local Research Awards for their contribution to Covid research.

Research transparency

A vision of the Health Research Authority (HRA) is that trusted information from health and social care research studies is publicly available for the benefit of all.

Research transparency is central to ethical research practice. Research studies should be registered, and the results made public, so that participants are protected from unnecessary studies and research funding maximised. When research is carried out openly and transparently, everyone will be able to see what research is happening and the outcomes from finished studies.

The promotion of research transparency is a priority for R andD at UHD. Below you can find a summary of each study that UHD has sponsored, along with a copy of the protocol and links to any publications or results.

---

• Download our summary of each study

---

The UK Government requires us to report our research initiation and delivery performance quarterly, along with all other research-active NHS providers.

The two key measures, for research studies or clinical trials we are involved in are:

Initiating all clinical research

1How rapidly the first participant is involved in a clinical trial after we have been selected as a participating site. As of Quarter 1 2018-19, this will no longer be assessed with a 70-day benchmark for the duration between Date Site Selected and date of First Participant Recruitment. A renewed focus will be placed on transparency, accuracy, and meeting sponsor expectations.

Delivering commercial clinical research

How we are doing at involving people in our current trials with commercial sponsors, and how many of our trials have involved the full number of participants we said they would, within the time we said they would

Both reports can be found here: CTP Submission Platform - Public Trust View (External site)

Dorset Clinical Research Centre (DCRC)

The Dorset Clinical Research Centre (DCRC) provides dedicated research space within University Hospitals Dorset NHS Foundation Trust (UHD) for the delivery of cutting-edge research studies with the aim of improving the health of our local community.

This dedicated space was originally used for the Dorset Research Hub and was one of a series of hubs set up across the region by the Wessex Clinical Research Network in response to the COVID-19 pandemic. The Dorset Research Hub enabled members of our community to take part in a number of urgent high-profile COVID-19 vaccine studies. Due to the success of this collaboration and with the full support of the trust board, the Dorset Local Enterprise Partnership* awarded the UHD Research Department approximately £500,000 to create the Dorset Clinical Trials Unit (DCTU) and to improve the research infrastructure and facilities to allow the team to attract and support further ground-breaking research in Dorset.

The DCRC is part of the DCTU which sits alongside the UHD Research and Development department, providing study management and delivery support to researchers.

With the recent investment of just under £500,000 from the Dorset LEP, our research centre provides space, equipment and staff within a state-of-the-art research facility to support our clinical researchers, industry partners and our patients to deliver high quality clinical research.

The DCRC can be found on the ground floor of the West Wing of Royal Bournemouth Hospital, in between Outpatients and Boots Pharmacy.

The DCRC has its own reception and waiting area providing a comfortable space to welcome patients and visitors. The space is also equipped to provide the perfect environment for small research or study-related public and patient involvement (PPI) and focus groups as well as other relevant research forums. We also provide dedicated wheelchair access which links directly to the hospital's disabled car park.

Our facilities include:

• Eleven consulting rooms, all with access to the UHD IT system and WiFi. We also provide Phlebotomy Chairs; BP monitors; ECG workstation; spirometry equipment; vein finder; infusion pumps. consulting rooms and equipment for patient visits can booked via our DCTU/DCRC team.
• Sample processing laboratory, with Class II Biological Safety Cabinet; Refrigerated Centrifuge; temperature monitored sample storage fridge and -20°C freezer; access to managed -80°C freezers
• Clean prep and storeroom
• Medication prep room with temperature monitored medication fridge linked to Pharmacy.
• DCTU meeting room with AV equipment
• DCTU staff offices and break-out areas to accommodate our administration team with bookable hot-desking spaces available for our researchers and study monitors.
• DCRC staff

We have a team of dedicated specialist research nurses and clinical trials assistants who are trained in the delivery of clinical research studies. If you would like to get in touch with the team, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

Dorset Clinical Trials Unit (DCTU)

The Dorset Clinical Trials Unit (DCTU) is situated within the Dorset Clinical Research Centre (DCRC) on the ground floor of the West Wing of Royal Bournemouth Hospital, in between Outpatients and Boots Pharmacy. The DCRC is part of the DCTU.

The Dorset Clinical Trials Unit sits alongside the UHD Research and Development department and provides management support for research investigators for:

• Development, delivery and analysis of high-quality research
• Contribution of evidence for improved healthcare outcomes for patients
• Providing research informed services and treatments within University Hospitals Dorset NHS Foundation Trust

Here at the DCTU, we have a team of dedicated specialist staff who are experienced in the management, oversight and delivery of research studies. If you would like to get in touch with the team, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

What is a Clinical Trials Unit?

Clinical Trials Units (CTUs) are dedicated units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and studies. They have the capability to provide specialist advice and coordination to ensure delivery of successful clinical trials.

What do the DCTU support?

The DCTU is able to help with supporting the design, set-up, delivery, analyses and publication of research in and around the Dorset area for:

• UHD NHS trust staff;
• Bournemouth University staff;
• Other local NHS services including primary care and community services;
• Industry small/medium enterprise companies.

What can the DCTU do to help you?

DCTU work in collaboration with the Research Design Service South West (RDS SW; find more information about them here Research Design Service South West (nihr.ac.uk)) for the initial stages of a research study and following this are able to support right through to publication. Our staff are currently able to offer assistance with the following:

Concept

• Study and protocol design advice
• Feasibility assessments
• Funding applications and reporting
• Research costings

Set-up and conduct

• Trial management
• Data management – including electronic data capture and query management
• Randomisation
• Pharmacovigilance
• Steering and safety committees
• Quality management

Analysis and reporting

• Statistical analyses and support (in collaboration with RDS SW)
• Publication

Why work with the DCTU?

• Ready-made systems and procedures which meet regulation and legislative requirements
• Expertise in trial and data management which means clinical staff can focus on clinical expertise
• Robust monitoring and oversight to ensure study is delivered to time and target

What are the aims of the DCTU?

• To provide comprehensive quality support to investigators within the Dorset region
• To increase availability of research involvement for patients locally
• To contribute to high quality research publications which inform clinical practice nationally
• To become a UK Clinical Research Collaboration (UKCRC) registered unit

Sponsorship

What is a sponsor?

A sponsor is an organisation (or group of organisations) that accepts responsibility for ensuring that there are proper arrangements to initiate, manage, monitor and finance a project. The sponsor's primary responsibility is to safeguard the rights, safety, dignity and well-being of research participants. In doing so, the sponsor will accept responsibility for securing the necessary arrangements to conduct the research and will ensure that all the necessary authorisations have been obtained before commencing.

The sponsor is also responsible for monitoring the research to ensure it is conducted in accordance with applicable legislation and the Good Clinical Practice (GCP) Guidelines.

The UK Policy Framework for Health and Social Care Research requires that all research taking place in an NHS or social care context must have a Sponsor.

For queries regarding sponsorship or to request UHD sponsorship of your research project, contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.. Please note that sponsorship requests must be received a minimum of 6 weeks in advance of an intended grant submission deadline for Sponsorship Group consideration.

Support departments

There are several departments within UHD which may support research studies taking place at the trust:

• Radiology
• Pharmacy
• Pathology
• Nuclear medicine
• Cardiac technicians
• Information governance
• Finance