Clinical Trials

• Randomised trials compare two or more different groups of patients. There is usually: 
  • A control group who get the standard treatment or placebo 
  • A treatment group who get the new treatment. 
• Randomisation is when people are put into either one of these groups by chance. A bit like flipping a coin. A computer 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 are where only the researchers know who is getting the new treatment or the standard treatment (control). 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.

• 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. This may include monitoring. 
  • If no standard treatment is available for their type of cancer. 

So, they are not losing out on treatment. 

• Everyone showing an interest in taking part in a clinical trial should get a study information sheet. 
• This tells you all about the trial and what you will need to do. You will need to read this carefully before giving your consent to take part in the trial. 
• You should also get the chance to speak to someone from the trial team. This may be a research assistant, research nurse or doctor.

• 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. 

Who manages the ethics committee?

• 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 is human tissue?

• 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 should 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 (this will open in an external tab). 

• Clinical trials are available for people at all stages of their cancer. 

• Some trials look for people who are newly diagnosed or in the early stages of prostate cancer. Others want people with specific symptoms. 

   

• Clinical trials can give you access to treatments that are not yet available on the NHS. 

• Strict guidelines are in place for all clinical trials. These make sure people get treated honestly and ethically. 
• All people have rights. Safety is a top priority. Before giving consent, you should get full and honest information about the trial. This includes information about risks and benefits.

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 learn more about their work on the Health Research Authority website (this will open in an external tab). 

• This will vary across trials. The trial may need you to have more:
  • Check-ups
  • Blood tests

  • Scans. 

    

• Some clinical trials will:
  • Need you to visit the trial centre once or twice a month. Others may require weekly visits or more.
  • Pay back your travel expenses.
  • Pay you to take part.
• The trial manager will give you this information before you agree to take part.

• There are hundreds of trials available at any one time. Your doctor may not know what trials are taking place that are suitable for you. 
• Look at our clinical trials finder to see if there is a trial to suit you.