Q: What is the purpose of clinical trials?
A: The purpose of clinical trials is to find more effective ways to prevent, diagnose, or treat disease. Every drug and procedure that is used in treatment was once studied as a part of a clinical trial. For example, the different type of trials can include those that look at how effective a medication is, which treatment interventions are best, or even include completing questionnaires or interviews to look at the experiences of patients with certain conditions.
Q: What phase is this trial and what does that mean?
A: All medications go through a number of stages, safety and quality assessments before they are approved for use. These stages are known as “phases” and are outlined below in a helpful diagram:
Source: What is clinical research? (uhs.nhs.uk)
Q: Have there been other trials similar to this one? If yes, what were the results?
A: If you would like to find out if there has been a clinical trial taking place that is similar to the one you have been approached about, please speak to a member of the research team on 02089342804, or email khft.research@nhs.net.
Q: What kinds of patients will be in the clinical trial?
A: Patients in a clinical trial need to fit strict entry criteria that is outlined in the study documentation and patient information sheet. Studies may need people of certain ages, genders, or with certain health conditions, to take part but anyone is able to take part in a clinical trial as long as they fulfil the study criteria. There are many studies so if one trial does not work for you, there may well be another that does!
Some studies, however, wish to include healthy volunteers, friends, members of your family or even a GP/ doctor that can support you in the study if you become too unwell to undertake the activities yourself. These are called consultees and you will be asked whether or not you would like to have a consultee if you decide to take part in a study.
Q: How many patients are needed for a clinical trial?
A: It changes depending on the trial as each one needs a different number of volunteers to gather enough information to answer the research questions. The patient information leaflet will tell you how many participants the study needs. For more information, speak to your researcher, or the study office, on the details provided on the information leaflet.
Q: How long will the trial take?
A: Each trial is different. Some trials will only require one visit, whereas others may require follow ups at time points over several years. You may or may not be involved for all of that time. You will be informed in detail as to how long the study lasts, and what is required from you, before you sign up to take part.
Q: Will I find out about the results of the clinical trial?
A: Results of a clinical trial will be published on the study website (the contact details will be on your information sheet), in journals, or you may be contacted directly by the study office if you have given consent.
Q: Do I have to tell people that I participate in a clinical trial?
A: It is recommended that patients should notify their GP and any emergency department/healthcare provider etc. that they are participating in a trial. These healthcare providers may need to be contacted for further information, by your research team, if you utilise these services e.g. admitted to hospital.
Q: Why is this clinical trial a good fit for me?
A: There are many reasons for why a trial may be a good choice for you, as well as reasons for why it may not be the right choice. You will need to discuss with your nurse or doctor, the research team, and perhaps your family and friends, to come to a decision that is right for you.
Reasons for why a trial may be a good fit for me:
Q: What are my treatment options if I don’t join this trial?
A: If you do not join the trial, you can discuss your treatment options with your nurse or doctor. The treatment you receive outside of a trial is called routine care.
Q: Are there other clinical trials that might help me?
A: If you would like to find out about other trials that may help you:
Q: If I agree to take part in a trial, how will my data be kept safe?
A: You data is secured under the principles of the General Data Protection Regulation and Data Protection Act 2018. Discussions with members of staff and your health information is treated with respect and in complete confidence as set out in the NHS codes of practice. Furthermore, we abide by the principle of Good Clinical Practice in research (GCP) which are legal guidelines for safely and securely conducting clinical research in the NHS.
GCP ensures that your data is kept securely in a locked area, accessible only by authorised staff. Your information can only be accessed by members of the study team, your clinicians and occasionally by members of the organisation conducting the research or national regulatory associations to ensure that the trial being conducted appropriately. All research studies that you take part in will be documented in your permanent health record at the Trust.
Q: What will I have to do if I join a trial?
A: Each study uses different ways of trying to understand your health condition, or to evaluate a medication or intervention. This means that you may be asked to do a variety of different things if you decide to take part.
These may include:
Every activity involved in the study will be discussed with you in detail before you decide to take part.
Q: Will I have to stay in the hospital?
A: Not necessarily. It depends on your condition and the study you take part in.
For example, if you are having surgery and have been approached to take part in a clinical trial looking at which type of surgery is best for you, then you would already be in hospital. The research will continue around you and your nurse, doctor or surgeon and the research team would be there to support you through the process. If you decide to withdraw from the trial, then the treatment you receive would be that which the surgeon feels is best in discussion with yourself.
Q: Will I have to come to the hospital for treatments and tests? How often?
A: It will depend on the study and all the information on this is outlined in the patient information sheet. Additional visits may be a possibility, as well as additional assessments and tests. You will be made fully aware of these before you decide to take part.
Q: Will I have to change my daily activities or my diet?
A: You may be asked to change your daily activities and your diet if this is what the trial is looking at. Some trials look at different types of behaviour or activities (such as level of exercise or types of physiotherapy) and some look at alternative diets that may help your condition. The decision to undertake these activities is yours to make, but we would encourage anyone who wishes to take part in a trial to adhere to what the study asks as best as they can. If you find that any of the activities are particularly difficult, then please discuss this with your researcher or clinician.
If the activities begin to make you feel unwell and your doctor is concerned, then they may wish to remove you from all or part of the trial and move you to an alternative treatment.
Q: Who will be in charge of my care?
Every trial is led by a lead clinician who is an expert in their field. They have overall responsibility for the care and treatment for everyone on a study. You will also continue to be cared for by your nurse or doctor (they may also be leading the study).
The research team will support you and your doctor to make sure your experience on the study is the best it can be.
Q: Will I be paid to take part in a study?
Not necessarily. Most research studies do not pay participants, but some may be able to support you with travel costs to and from the hospital. The patient information sheet should say if the study does this, and for more information please speak to the research team via the number provided on the sheet.
Q: If I have questions about a trial, whom can I contact?
A: The information sheet you were given about the study has all the information you need. At the back it will have a telephone number for the Research and Innovation Department at Kingston Hospital which you can call, as well as details of how to contact the university, company or institute leading the study.
You may have also been given a study card with the details of research and clinical staff on it for your convenience.
If you cannot find your information sheet, please contact us in the Research and Innovation Department on: khft.research@nhs.net, and we will get in touch with you as soon as possible.
If you are on a clinical trial already, please let us know the name of the study and the name of your doctor at the hospital.
If you are new to research and would like to find out more about if there is a study at the hospital that is suitable for you, please email khft.research@nhs.net and someone will be in touch with you.
Q: If I agree to take part in a trial, how will my data be kept safe?
A: Your data is secured under the principles of the General Data Protection Regulation and the Data Protection Act (2018). Any discussions, or documentation, regarding your health is treated with respect and in complete confidence as set out in the NHS code of practice. Furthermore, we abide by the principles of Good Clinical Practice (GCP) in research, which are legal guidelines for safely and securely conducting clinical research.
GCP ensures that your data is accessible only to authorised staff. This may include members of the Research team, your clinician(s), members of the organisation conducting the research, or national regulatory associations who ensure that the trial is being conducted appropriately. All research studies that you take part in will be documented in your permanent health record at the Trust.
When considering entry into a study, the Patient Information Sheet and Consent Form for the study will provide detailed information regarding who will have access to your information and in what format.
Q: Where can I access GCP training?
A:
NOTE: You must use Microsoft EDGE, Google CHROME or FIREFOX to complete the training online.
Q: Do I need to complete GCP training?
A: Yes, everyone in the Trust who is on a delegation log to work on a trial, no matter how simple it may be, must complete GCP training. For many trials this is a legal requirement and for Kingston, it is the fundamental qualification to ensure you understand how to run a trial.
Q: Where do I send my GCP certificate once I have completed the course?
A: Please send the certificate to khft.research@nhs.net, along with your completed CV (enter research template link here), cc’ing in the Study Lead within the Research and Innovation department, as well as the Research Lead/Principal Investigator in your Department.
Q: Where do I access other National Institute of Health Research training?
Q: What research training is relevant to me?
A: We recommend anyone who is new to research to complete their GCP training as a foundation. After that, look at the different GCP modules that relate to your area, such as Paediatrics or Adults Lacking Capacity.
Next Steps into Research training: New to Research? This course enables attendees to discuss with colleagues from across the network to develop their understanding through shared learning. This is a two-day course which, among other things. covers consent, roles and responsibilities, challenges to recruitment and GCP application.
For any new or returning Principal Investigators we would ask you to sign-up to the PI Essentials training. This is a half-day group session for PIs and covers setting up studies, roles and responsibilities, target setting and more.
Informed consent: This course aims to support high quality recruitment and to prepare you for any potential challenges you may encounter.
Q: I am working in a research active area, do I need to do GCP if I am not involved in a study?
A: If you refer patients who may be eligible for a study to colleagues, or just work in a unit where research is taking place and have no active engagement with study activities, then you do not need GCP training. For those supporting research delivery, please look at Research Practice in Clinical Settings.
Q: I have an idea for a study, what do I do now?
A:
Step one: Have a discussion with your colleagues and write down your initial ideas.
Step two: Email the research governance inbox (khft.researchgovernance@nhs.net) to book a time to discuss with one of our team. You may need to involve the Research Design Service (RDS), based at Kings College, to support you in developing your idea.
The research governance team can support you in making these links, and in registering your study on the IRAS (Integrated Research Application System) for approval by the Health Research Authority and the relevant ethics committee(s).
