Clinical Trials

What are randomised control trials?

Randomised trials compare two or more different groups of patients. There is usually: 

• A control group who get the standard treatment or placebo, and 
• A treatment group who get the new treatment. 

Randomisation is when people are put into either one of these groups by chance. A computer randomly decides which group you are in.

Randomisation is the best way of making sure that the results of trials are free from bias. 

What are blinded trials?

• Blinded trials are where only the researchers know who is getting the new treatment or the standard treatment (control). As a patient, you will not know. 
• In double-blinded trials, no one knows which group you are in. Each person gets a code number.  A computer then decides which group you are in.

What is standard of care treatment in a clinical trial?

• Standard of care treatment is the treatment that you would have had if you were not in a clinical trial. 
• This is the one accepted by medical professionals as being the most appropriate treatment for a particular condition. 
• The standard of care treatment is used to compare against the new treatment. 

What are eligibility criteria?

• Eligibility criteria are a set of conditions (criteria) that must be met for someone to take part in a clinical trial. 
• They make sure people taking part in a trial are as similar as possible in terms of things like:
  • Type of disease.
  • Stage of disease (e.g. early prostate cancer). 
  • Age and sex.
  • Ethnicity. 
  • Treatment history.
• This allows researchers to see if any results are because of the new treatment or other things such as treatment history. 
• Criteria will differ from study to study.   

What is a placebo?

• A placebo is a dummy treatment. 
• It is often designed to look the same as the trial treatment. But it does not do anything (it’s not ‘active’). It is sometimes called a ‘sugar pill’. 
• Researchers use a placebo to find out whether the new treatment works better than doing nothing at all. 
• People with cancer would only get a placebo:
  • Alongside a standard treatment. In the case of prostate cancer, this may include active surveillance. 
  • If no standard treatment is available for their type of cancer. So, they are not losing out on treatment. 

Will I get information about the trial before I make up my mind?

• Everyone showing an interest in taking part in a clinical trial will get a study information sheet. 
• You will also be asked to read and sign an informed consent form.
• The study information sheet and consent form tell you all about the trial and what you will need to do. This includes the risks and benefits of taking part. You will need to read them carefully before giving your informed consent to take part in the trial. 
• You will also get the chance to speak to someone from the trial team. This may be a research assistant, research nurse or doctor.

What is informed consent?

• Everyone taking part in a clinical trial must give their informed consent to take part. 
• Informed consent is a process that makes sure that you understand all aspects of the study and agree to take part voluntarily. 
• Informed consent must be given voluntarily. 
• Before giving your consent to take part, someone will tell you about:
  • The purpose of the trial
  • The length of your involvement in the trial
  • What is expected of you during your time on the trial
  • Any treatments, interventions or tests you will have
  • Any possible risks or benefits of taking part
  • Who to contact if you have any questions or issues.

• Before making your final decision, you should:
  • Make sure you understand everything you have been told by the research team. If you are not clear on anything, don’t be afraid to ask questions.

  • Take time to talk to your family, friends and healthcare team. 

     

• You can sign the consent form once you are:
  • Confident that you understand what the trial involves for you
  • Happy to take part
• Even when you have agreed to take part, you can still leave the study at any time. You do not have to give a reason. The consent form is not a contract.

What is a research ethics committee (REC)?

• A research ethics committee is a group of people not connected with the trial. 
• They look at the research plans for clinical trials to make sure that they respect participants': 
  • Dignity 
  • Rights 
  • Safety 
  • Well-being 
• They also look to see if patients are involved in the planning of the research. 
• These ethics committees are managed by the Health Research Authority (HRA). This is a publicly funded organisation. 
• Their main role is to protect and promote the interests of patients and the public in health and care research. 
• You can find out more information about RECs on the Health Research Authority website (this will open in an external tab).

What happens to tissue samples that are collected in a clinical trial?

• If researchers want to collect tissue including: 
  • Blood 
  • Bone 
  • Hair
  • Organs 
  • Prostate biopsies

for use in their research trial, they need to ask you to give your consent. 

You will be given written information about what will happen to your tissue sample. Always read the consent form very closely before you sign it. 

• Some researchers may want to use the tissue for future research. This is usually voluntary. They will need your consent to keep your tissue. They will also have to apply for separate ethical approval. 

Who regulates tissue collection?

The Human Tissue Authority (HTA) are an arm’s length body of the Department of Health and Social Care. They:

• License and inspect organisations that collect human tissue
• Make sure organisations remove, store and use tissues in an appropriate and respectful way
• Make sure that organisations ask for your consent.

You can find out more about their work by visiting their website: https://www.hta.gov.uk/

What happens at the end of the trial?

• At the end of your time in the trial, the trial team will discuss your future care. 
• If you have been having an experimental medicine, you will not be able to carry on taking it after the trial has ended. 
• However, you will be followed up by the research team to monitor any long-term effects of the medicines. 

How can I find a clinical trial that's suitable for me?

Your journey begins with finding a clinical trial that's right for you. There are different ways to find these trials.

a. Your doctor may know of a trial suitable for you. They can make a referral to the trial team.

b. Your doctor may be involved with a clinical trial that is suitable for you.  They will be able to give you more information.

c. You can explore clinical trial finders like the one on the Infopool website. If you find a trial that seems suitable for you, talk to your healthcare team for advice.

d. Consider becoming a research volunteer. It's a great way to learn about trials and be among the first to know about them. Ask your healthcare team for more information.

What information will I be given?

During this visit, you'll get detailed information about the study. This will involve guiding you through the informed consent. This will include things like:

• The purpose of the study 
• What's expected of you
• Your rights as a participant 
• The eligibility criteria and whether you meet the requirements for the study
• The risks, side effects and benefits of taking part.

Who can I talk to about the study?

You will get an information sheet to take home. This will give you the chance to talk it over with: 

• Family
• Friends
• Your healthcare team. 

Remember:

• You are a volunteer so can leave the trial at any time
• It's okay to take your time and ask questions.

Will I need to have any tests?

Depending on the trial, you may need some extra tests to make sure you are: 

• Suitable for the trial and
• It's safe and for you to take part.

The research nurse may do your: 

• Blood pressure
• Pulse
• Temperature and take some blood. 

You may also have a tracing of your heart (ECG). For some trials, you may need to have a CT or MRI scan. 

When can I sign the consent form and start the study?

You can sign the consent form and begin your clinical trial journey. when you are:

• Found to be eligible for the study and 
• Are happy to take part

What happens at the baseline visit?

• You may have some baseline tests done again for example, blood pressure and pulse. 
• You will receive instructions on medications if needed. 
• You will be given dates for future visits. 

• Throughout the trial, you'll make regular visits to the trial centre.
• Some catch ups with the team may be done remotely for example, on the phone or online. 
• These visits help the research team monitor your progress and well-being.

What happens at the final visits?

• As the trial nears its end, you'll have final visits for: 
  • Assessments, and
  • Discussions about your future care. 

Can I carry on taking the study medicine?

• If you have been having an experimental medicine, you will not be able to carry on taking it after the trial has ended. 
• However,  the research team will follow-up with you to monitor any long-term effects of the medicines. 

What happens with my ongoing treatment?

• At the end of your involvement in the trial, you will be referred back to your own healthcare team. 
• They will decide what needs to happen next.

Will I hear about the results of the study?

• After your part in the trial ends, the research may continue for some time longer. 
• So, results may not be available for a long time. 

Are there any points I should remember?

• Remember, your voice matters. 
• Keep asking questions and stay informed every step of the way. 

How can I find out more about clinical trials?

• If you want more information about clinical trials:
  • Stay on the Infopool and look around the site
  • Listen to stories from others who have taken part in clinical trials.