Ask Dr Charlie

FAQ for Parents/Carers

 

What are clinical trials and why do we research medicines?

Why do research in children?

Why are clinical studies significant?

What are the benefits of clinical trials?

Are clinical trials safe to participate in?

How do I join a clinical trial or locate further information about how my child can be involved?

The Consent and Assent Process and Informed Consent - So what is informed consent?

What is a patient information sheet?

What type of questions should I ask researchers before participating in any research?

How do I find information about the results and findings of a research project?

 

 

Question: What are clinical trials and why do we research medicines?

Answer: Clinical trials are research studies in which people including babies, children and young people can test medicines that are already in use and sometimes those that have not been used. This is to see if they are safe and effective.

Research can be anything from the testing of a medicine or a form of therapy. You may also be asked to complete a small questionnaire, asked for a blood sample or another type of measurements such as blood pressure, height or weight. Sometimes you may even be asked permission for someone to review your child's medical notes to see how your treatment or care has affected your child's condition.

Patients who take part in trials are usually volunteers. However, in some cases very young children and babies, the parents/carers will make the decisions. Although, children and young people can consider if they also want to be involved but they cannot take part without their parents/Carers consent.

 

Question: Why do research in children?

Answer: Medicines, devices and treatments are often not tested in children. At nearly half of medical visits, children are given a medicine and most of those medicines have only been tested in adults.

We would not know as much as we know today if people were not brave enough to be in clinical trials. So it helps future generations.

Children are growing. They are changing and maturing all the time. When thinking about the right dose for a child, we look at the stage of growth:

Stages of Growth

Stages of growth

An 8-month-old is entirely different from an 8-year-old, who is completely different from an 18-year-old... so even among children, everyone is different. And at each of these stages of growth, they may need different doses of medicine, different device sizes or different types of therapy.

For example, testing of one antibiotic showed that babies needed higher doses than older children to get rid of their infection. Many medicines are filtered out of the body and handled differently by a child's developing liver or kidneys - and because there is limited research, we don't know what the long term effects on these organs may be. So, we need to study them to find out.

 

Question: Why are clinical studies significant?

Answer:

 

Question: What are the benefits of clinical trials?

Answer: Clinical trials will help develop the most effective treatments and advance the healthcare of children and young people with many various conditions.

Research is the only way that new medicines are able to be introduced due to new European Union laws introduced in 2007. As a result all new medicines entering the market place that are suitable for the use in adults will also have to be researched with children and young people.

 

Question: Are clinical trials safe to participate in?

Answer: Many people take part in thousands of clinical trials in the UK each year. Recently this has included a lot more children throughout the UK.

Before you or your child are asked to take part in any clinical trial, the research trials will have been through many rigorous processes and would have taken a long time to get to the stage of asking patients to be involved.

In certain cases it will have taken many years to get to the stage of actually testing a medicine, even when the medicine is already in common use.

Trials have to go through what is called an Ethics Committee who will look at a trial in a lot of detail in order to ensure that people participating in a trial will be protected in terms of their rights, dignity, safety and well being.

Lots of trials will go through a "Peer Review" process whereby doctors, nurses and members of the public will have their chance to put across their point of view for a certain trial.

Each trial is also designed to keep risks to an absolute minimum. Children and young people will only be asked to participate if they meet certain criteria as the treatment being tested may be offered anyway to treat their condition. For all trials the participants' safety and well being is the upmost priority.

 

Question: How do I join a clinical trial or locate further information about how my child can be involved?

If you have seen a poster with information on or are interested about a clinical trial speak to your doctor or contact the Cheshire, Merseyside  North Wales Medicines for Children Research Network based at Alder Hey Children's hospital.

The Cheshire, Merseyside  North Wales MCRN will then send your details on to the relevant people who will then contact you by your preferred contact method.

Just send an email to jason.gladwin@alderhey.nhs.uk

Any information that you send to us will be kept confidential and you will receive a telephone call, Email or letter to ask you if we are okay to send your details to the relevant people.

 

Question: The Consent and Assent Process and Informed Consent - So what is informed consent?

If your are asked if your child would like to participate in research you will be then asked to give what is called "Informed Consent." This is your agreement that you are happy for your child to take part in the research.

Participation in a trial will not take place until you have read all the patient information sheets and the study has been explained to you in depth by the research nurse or doctor. You should fully understand what will happen and if you don't you should always ask before giving your informed consent. Your decision can only be informed when you know everything that may happen including pain and discomfort, how often medication would have to be taken and how many hospital or clinic visits will be required. Prior to you giving informed consent you will be given a Patient Information Leaflet that will explain the purpose of the trial and how it will be carried out.

Once you have read the information sheet you should ask the researcher about anything you may be uncertain about and you should never think that your question is not important.

You should never feel that you are being pressured to participate in research and remember you do not have to give consent for your child to take part in a trial if you don't feel comfortable in them doing so.

If you do agree to take part you will be asked to sign a consent form and this will also need to be signed by the person who is responsible for the trial at the hospital.

Children who are under the age of 16 will need to complete an assent form.

 

Question: What is a patient information sheet?

The patient Information sheet will give you all the information about a Clinical Trial. Before this information sheet can be given to patients it has to be accepted by an ethics committee to ensure that information is informative and not misleading.

They are separate Patient Information Sheets for different age groups such as parents/ carers, young children age 5 to 10 years old and older children between the ages of 11 to 15 years old.

The patient Information Sheet should contain the following bits of information:

What type of questions should I ask researchers before participating in any research?

If you feel that we have left out any important questions and think that we should add them to this list please email jason.gladwin@alderhey.nhs.uk.

 

Question: How do I find information about the results and findings of a research project?

The research findings are normally reported in Medical Journals. Although, your doctors will be able to provide you with a copy of this.

Nevertheless, as more people become involved in research these results will be accessible in many different ways. Researchers are finding that in the past patients that have participated in research did not get informed about the findings and results of the research. Therefore this is one area that is being improved, especially as more people are being involved in the research process at the very early stages.

The patient information leaflet should state how you can access information about the research projects findings. If you are still uncertain then you should ask the doctor or nurse who is your main contact for the study.

It is important to note that in quite a few cases the finding of research does not become available until many years after you agreed to take part.