Clinical Trials

A clinical trial compares the effects of one treatment with another. It may involve patients, healthy people, or both.

Learning about clinical trials

 

Have you ever thought about getting involved in a clinical trial but were unsure about what is involved?

From common myths to who you will meet along your clinical trial journey, this page aims to answer your questions. You can also use our clinical trial finder to look for a trial that is suitable for you. 

Start by watching our short video for an overview of prostate cancer clinical trials. 

Explore possible clinical trials using our clinical trial finder

10 things you need to know about clinical trials.

 

 

 

Randomised control 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. 

Blinded trials 

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.

Standard of care treatment

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. 

Eligibility criteria

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 like treatment history. 
  • Criteria will differ from study to study.   

 

Checklist

Placebos

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. 

 

Box of capsules with placebo written on it

Trial Information

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.
  • These 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.

 

Folder with sheets of paper inside

Informed consent

What is informed consent?

Informed consent form

 

  • Everyone taking part in a clinical trial must give their informed to take part. 
  • 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. 

       

  • Once you are:
    • Confident that you understand what the trial involves for you
    • Happy to take part

      you can sign the informed consent form. 

  • 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.

Research ethics committee

What is a research ethics committee?

  • 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 the: 
    • Dignity 
    • Rights 
    • Safety 
    • Well-being 

      of the people who take part. 

  • 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).

 

People sitting around a big table

Tissue samples

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. 

 

Bottle of bood labelled PSA test

 

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/

After the trial has ended

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. 

 

Black doctor smiling shaking hands with White middle aged male patient

What are clinical trial phases?

Clinical trials of new medicines go through four main stages or phases. These phases look at:

  • Whether the medicines are safe
  • How well the medicines work. 

This infographic gives a simple overview of the 4 phases of clinical trials.

Infographic showing the 4 phases of a clinical trial

 

 

Ethnicity and clinical trials

  • The results from clinical trials are applied to all communities. But often, there is not an equal mix of ethnicities in clinical trials. 

 

  • For example, one-in-four Black men will get prostate cancer compared to one-in-eight White men. But Black men are less likely to be represented in clinical research. 
Image
3 men of different ethnicities

Why is it important for people from all ethnicities to take part in clinical trials?

  • It is important we have a mix of ethnicities taking part in research around prostate cancer. Otherwise, it is difficult to know whether:
    • Treatments or new tests will work equally for all ethnicities 
    • Treatments will have the same risks and side effects for all ethnicities
    • Prostate cancer develops in the same way in different ethnicities 
    • Genetics related to ethnicity play a part in the development of prostate cancer. 
  • This may mean that people from different ethnicities are not always getting the full benefit from advances in science. 
  • Treatments need to be effective for all people. 
  • Results from clinical trials are used to write clinical guidelines. These help doctors to make decisions about what treatments to give to patients. 
  • Knowing that treatments are tested on people who are of the same ethnicity as you can help to build trust. 

 

 

Image
Older Black man talking to Black Doctor in a white coat
Image
Alfred
"Taking part in research like clinical trials is important for Black men. Not only does it offer the chance to access the latest treatments but unless we take part now the medicines of the future may not be suitable for our sons and grandsons."
Alfred

 

 

The journey through a clinical trial: from finding a trial to trial end

The journey through a clinical trial will be slightly different for each trial. In this next section, we will take you through a typical journey.  The infographics show the steps you may go through if you decide you want to get involved in a clinical trial. 

 

 

1. Finding a trial suitable for you

Finding a trial infographic

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.

2. Learning more about the study: your first meeting with the research team

Learning more about the study infographic

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. 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.

3. The screening visit: making sure you are eligible to take part

Screening visit infographic

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?

If you're:

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

You can sign the consent form and begin your clinical trial journey.

4. Starting the trial: the baseline visit

Baseline visit infographic

What happens at the baseline visit?

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

5. Taking part in the trial: visits to the trial centre

Visits to the trial centre infographic
  • 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.

6. The end of the trial

End of the trial infographic

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, you will be followed up by the research team 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?

  • Though 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.

 

 

Image
John
“I retired in 2019 because I was really not very well at all and the last three years I have been on a trial drug at the Royal Marsden, which has bounced me back to rude health.”
John

About this information

  • This information was published in May 2024. We will revise it in May 2026.
  • References and bibliography available on request.
  • If you want to reproduce this content, please see our Reproducing Our Content page (this link will open in a new external tab).

 

The clinical trial toolkit is an information resource for people affected by prostate cancer. The toolkit development has been funded through an educational grant from Parexel.

Please note that this clinical trial finder may not show all trials that might be available to you. There may be some local trials that are not picked up by it due to the fact there is no single database for all clinical trials. If you are interested in taking part in a trial please do speak to your healthcare team as they may be aware of some trials local to you.

NB if using a private browser or incognito mode you may need to enable cookies to make this finder work.

 

 

 

Five common myths you may hear about clinical trials

You will hear many myths about clinical trials. This short animation aims to debunk the five most common myths. 

What questions should I ask my clinical trial research team?

  • Many questions will be answered in the informed consent sheet. 
  • Your research nurse will take you through the informed consent. They will answer any questions you may have. 

Here are 10 top questions that may not be covered in the informed consent. 

 

10 questions to ask about clinical trials

Who will I meet along my clinical trial journey?

Watch this short animation to learn more about the professionals you will meet if you decide to take part in a clinical trial.

About this information

  • This information was published in May 2024. We will revise it in May 2026.
  • References and bibliography available on request.
  • If you want to reproduce this content, please see our Reproducing Our Content page (this link will open in a new external tab).

 

The clinical trial toolkit is an information resource for people affected by prostate cancer. The toolkit development has been funded through an educational grant from Parexel.

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