Why do Leicester’s Hospitals carry out clinical research?

We are a university hospital which means that new doctors and nurses work here as part of their training. This training can carry on to consultant level too. All practical training takes place alongside being taught at a university.

Specialist doctors spend many years training and undertaking research into specific conditions to make them leaders in their fields. Universities support this work by allowing them to undertake further qualifications and conduct clinical research as part of that. The hospital supports them by providing them with a clinical role and facilities to allow the research to happen.

All this means is that some of the best doctors and nurses in the country work here because they can carry out research into new medicines and treatments.

Who can take part in a clinical trial?

Research can happen in any specialty so anybody could be asked if they would like to take part in a clinical trial.

Leicester’s Hospitals are fortunate to have some of the best researchers – doctors and nurses – in the country working here. They cover many areas, such as cancer, cardiovascular (heart), diabetes, emergency, neonatal (pre-term babies), older people, paediatrics (children), renal (kidney), respiratory (lung), surgery, and many more.

I’m coming into hospital today to see my clinician. Should I ask them if they know of any research that I can take part in?

Absolutely! If research isn’t mentioned, just ask if there is something that you can take part in. Your clinician won’t mind being asked and will let you know if they are aware of anything happening in that specialty.

If they don’t know, just fill in our form on this website and a member of our Research and Innovation team will get back to you.

Why have I been asked to be in a clinical trial?

There are several reasons.

  1. You are likely to match the inclusion criteria
  2. There is research being done in that specialty and your clinician wants to know if you are interested in taking part
  3. The clinical trial that you are eligible for will give you a choice of how you are treated for your condition.

Every research study, when it is being created, identifies which patients are eligible to take part. This is called the ‘inclusion criteria’.

The inclusion criteria is designed to identify the patients that the trial may best help. If you have been approached and asked to take part, it is because you match this criteria.

If I take part in a trial, will I see the same clinician every time?

It is very likely that you will see the clinician who consented you into a trial. Usually though, your clinician will be part of a research team and depending on what your appointment is for, it will determine who you will see when you come in.

Generally speaking, research teams aren’t very big and so you are likely to recognise the members of the team at your appointments.

When my clinician spoke to me about taking part in a trial, they said something about being randomised. Am I in the trial or not?

Randomisation is a term to describe a certain type of clinical trial. And being ‘randomised’ is a process.

Some trials have ‘placebos’ which is a drug like the one being tested but missing the particular ingredient or compound which makes it new or different. If a clinical trial is trying to recruit 20 patients, 10 will be given the new drug and 10 will be given the placebo. This is so a comparison can be made to see if the new medicine gives different results.

When a person agrees to take part in the trial to become a research participant, there is a system that decides whether or not they receive the new drug or the placebo. This system allocates the treatment at random and so that person is randomised into the trial.

I’ve got several conditions and I’ve been asked to take part in a clinical trial for one of them. If I do this, will it affect anything else?

Every research study, when it is being created, identifies which patients are eligible to take part. This is called the ‘inclusion criteria’.

The inclusion criteria is designed to identify the patients that the trial may best help. If you have been approached and asked to take part, it is because you fulfil this criteria.

It is very important though that you are aware of how a trial looking into one thing, may affect your other conditions. Do ask your clinician if you have any concerns. Also, ask how your other clinicians for your other conditions will be informed.

If I don’t respond well to the treatment, will I have to keep taking part?

No, absolutely not. Your health is our primary concern and will always be. We are very careful to make sure that if you are approached about taking part in a clinical trial, it is because it is a suitable course of treatment for you.

However, as with all things, every person is unique and we can’t predict how each individual’s body will react to certain types of treatment. We monitor you very closely when you’re in a research study and we know that you are not responding well, we will look at what we can do to solve that.

What time of day will I be asked to come in?

That all depends. If you are attending an appointment as a research participant, then you will receive an appointment that is within the hours of that clinic.

If you are attending a meeting, is likely to be during the day or early evening.

If you are attending an engagement and involvement event, it is more likely to be in the evening or weekend to make it more convenient for the majority of people.

Will it cost me anything to be involved?

The answer to that question is yes and no. The main thing that you will lose is time. Attending an appointment as a research participant or a meeting as a PAG member will require time out of your day.

In terms of out-of-pocket expenses, it is unlikely that you will have to spend any money that you cannot claim back. It also may be different for each of the roles. For example, a research participant may have travel costs which they could claim for but it is very unlikely that they will get paid for taking part in a clinical trial. If an individual is a member of a PAG or is a lay member of an executive committee, they are required to undertake work for the Trust as part of that role and so will receive recompense for their time.

I’ve agreed to take part in a clinical trial. Do I have to tell my GP?

It is normal practice for the research team to write to your GP to inform them that you are taking part in a clinical trial and what it is for.

However, it is always worth ensuring that your clinicians have as much information as possible to ensure that they can help you when you see them. So, do tell your GP when you see them to make sure that they are aware of your current treatment.

If I change my mind, can I drop out?

Yes, absolutely. Becoming a research participant in a trial is an optional course of treatment. Sometimes it doesn’t suit a person to take part or there are extenuating circumstances which mean they cannot give the required time to the trial. Whatever the reason may be, we know that this happens and your care will continue within Leicester’s Hospitals.

I’m a carer and I’ve been asked to give my consent to the person that I care for to take part in a trial. Is that allowed?

If the person that you care for is unable to give consent on their own, their legal guardian has the responsibility of making decisions about their healthcare.

What you will have been asked to provide is ‘Assent’. ‘Consent’ can only be given by the individual. Assent is requested when either children or those that lack capacity to make legal decisions are approached to take part in a research study.

I’m a carer. Although I don’t have a specific condition myself, I still think that my experience might be useful. Can I be in a patient advisory group or become a lay member?

Please do! Your life experience is invaluable. Each service user’s experience is unique to them and we want to know your views.

What a patient, patient’s family member or carer has, is first-hand knowledge of how certain conditions affect everyday life. We want each of our research studies to be successful and your knowledge will inform us on what might encourage people and make it easier to take part.

I’m a parent and I’ve been asked to give my consent for my child to take part in a trial. I’m not sure what it means and I don’t want them to be tested on.

A clinical trial is part of standard care options. If you have been asked if you would like your child to be put in a clinical trial, it is because there is a different or new course of treatment or procedure that they may be eligible for.