About Clinical Research

New treatments or devices have to be carefully tested before they can be used in the clinic to treat diabetes or improve the lives of people with diabetes.

To do this, researchers run studies called 'clinical trials', where new treatments and devices are thoroughly tested in volunteers to find out:

• If they are effective
• If they work better than existing treatments
• If they have any side effects
• and crucially, if they are safe

As well as testing treatments or devices, trials might also be carried out to:

• Test or find new ways to prevent a disease
• Explore alternative ways to use existing treatments
• Find new ways to screen for, or diagnose a disease
• Explore ways to improve the quality of life for people with serious medical conditions

There are four main types of clinical trial, depending on where they fall in the drug development pipeline. These are:

• Phase I - research in a small number of healthy volunteers to assess whether a new treatment is safe in people and which dose works the best
• Phase II - research in slightly larger numbers of people with a particular disease to see if it works
• Phase III - research in large numbers of people to compare a new treatment with existing treatments to see if it works better
• Phase IV - research conducted after a drug has been licensed for use to collect information such as long term risks and benefits and side effects

Clinical trials must be carried out to extremely strict standards by law.

How are trials carried out?

Trials are run by highly trained research professionals under tightly controlled conditions, and must be carried out by law to extremely strict standards.

Researchers must conduct the trial according to a detailed plan called a 'protocol'. The protocol describes:

• The treatment or device being tested
• Why they are running the trial – the scientific reason
• What the researchers are looking to measure and why
• How many people will volunteer to take part, and if they will be people with a certain disease or healthy (or both)
• What the volunteers will need to do, and how often
• How long the study will last

All protocols must be approved by an 'Ethics Committee', a group of individuals who assess that the trial is ethically sound, before the trial can start. If the researchers want to make any changes to the protocol at any point, it must be approved by the Ethics Committee

Are clinical trials safe?

Regulatory bodies and researchers work to protect participants in clinical trials and to ensure that people have access to accurate information before they decide to join a clinical trial.

Clinical trial conduct in the UK is also governed by strict European laws and a series of guidelines that ensure volunteers who take part are protected from unnecessary risk.

Volunteers who take part are asked to sign an 'informed consent' form before they join a clinical trial. This form ensures that the person taking part:

• Is willing to take part;
• Understands the trial and what will happen
• That they understand what risks might be associated with the study
• That they can leave the clinical trial at any time

By their nature, clinical trials carry a degree of risk - some more than others - but every effort is made to ensure that those risks are as limited as possible, and that trial participants are appropriately taken care of at all times.

Find out more

Find out more about DTU’s clinical trials.