What is a clinical trial?
A clinical trial is a research study that involves testing or studying a drug or medical device to see if it is a safe and effective treatment for people. There are strict rules that control how clinical trials are conducted, to ensure the safety of those who participate.
For further information visit our ‘What is research?’ page.
What is a protocol?
All clinical studies are based on a set of rules or directions called a protocol. A protocol describes what types of people are eligible to participate in the study, establishes the schedule of tests, procedures, medications and dosages, and sets the length of the study. It also helps to make sure that the study is carried out the same way at each study site by giving the staff a clear set of guidance to follow.
How is research regulated?
Clinical research studies go through several robust checks and approvals before they can begin. These reviews are conducted by a Research Ethics Committee, the Health Research Authority and other regulatory authorities, as well as by clinical and managerial teams within the hospital.
What will happen to me if I participate in a research study?
It is difficult to be specific as each study is designed to investigate something different, meaning the duration of the study and the investigations required. Investigations may include blood sampling, different types of monitoring, x-rays or other imaging, but these will vary depending on the type of study. You will be provided with detailed information about a study if you are considering participating.
All of our studies are well-regulated and managed, and with research being embedded into the day-to-day work of the Trust, you can always be assured of excellent standards of care and safety.
Are there risks involved in participating in clinical research?
There may be risks involved in clinical research, as there are in standard medical care and in day-to-day life. All research studies are designed to minimise the risks involved.
Trials are being undertaken every day within the NHS and are managed by doctors and health professionals that may be responsible for your care.
The specific risks associated with any research study are described in detail in the participant information and consent document, which you are asked to read and sign before taking part in research. A member of the research team will discuss the document with you, including any risks), and you will be given time to ask questions and have them answered.
Do I have to take part?
No. Taking part in research is entirely voluntary. If you are invited to participate in a study, you will have time to consider whether you would like to or not. If you decide not to take part in the study your NHS treatment will not be affected and you will continue to be looked after like any other NHS patient.
Getting started
Your doctor or nurse, or another member of the healthcare team looking after you, will have explained your medical condition to you before explaining any clinical trial and inviting you to consider participating.
At the outset you will receive a ‘patient information sheet’ providing you with details of what the trial is trying to achieve and what this will involve in terms of any extra medical care or follow up. After you have had time to read the information sheet and ask questions, you will meet with your doctor, nurse or member of the research team to sign a consent form for the research study/trial. Please keep a copy of both the information sheet and signed consent form as they provide useful information that you may want to refer back to. The information sheet will also provide the contact details of your doctor and the dedicated research nurse/midwife who will be able to answer any queries you have.
Can I withdraw from a trial or research study?
Participating in research is entirely voluntary. You can change your mind about participating in a clinical trial or research study at any time. If you decide to withdraw from a study then this will not affect your access to standard NHS healthcare.
Will I be paid?
You may receive reasonable travel expenses depending on the individual study and whether it involved any additional visits to the hospital. The research team for the study you are involved in will be able to provide you with details.
Members of our research teams
Principal Investigator (PI)
The lead person at your hospital designated to take responsibility within the research team for the conduct of the study. This is often a consultant or other doctor, but for some studies this could also be a research nurse of another authorised health professional.
Research Nurse or Midwife
A qualified and registered healthcare professional who works alongside the PI to ensure the trial is conducted accurately. They will ensure any tests or appointments that are required for the clinical trial are organised so that your progress can be monitored and data collected. Once your treatment has stopped, and if the trial requires it, they may also be the person responsible for following up your progress for many years. They will also be able to guide you through the clinical trial and answer any trial related questions you may have.
Clinical Research Practitioner
Has a similar role to the research nurse or midwife but is not a qualified healthcare professional. They have specific experience and training to support research in the healthcare setting.
Specialist Nurse
An experienced nurse with in depth knowledge of a particular medical specialty – they will be able to answer questions if you have any worries about your medical condition.
Clinical Trial Pharmacist
A hospital pharmacist who specialises in dispensing medication for patients participating in clinical trials. This may range from tablets that you are given to take at home to chemotherapy treatments given in our day units or as an inpatient.
Research, your health information and GDPR
With the recent changes in data protection due to the General Data Protection Regulation (GDPR) you may have questions about how this new approach affects access to and use of personal data in terms of clinical research studies within the NHS. Generally much of GDPR is about being lawful, transparent and fair when collecting, using or holding personal data, in line with the safeguards already in place for clinical research trials. To find out more see the Health Research Authority for ‘patient information and health and care research’ website and patient data and research leaflet.
If you would like to find out more about how why and how patient data is used in research, the Understanding Patient Data website has a short video to help explain.
The National Institute of Health Research (NIHR) have also produced a helpful document ‘Your Health Record Saves Lives’. It explains what research is and how your health information contributes to improving care and developing new treatments for patients.