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:
As well as testing treatments or devices, trials might also be carried out to:
There are four main types of clinical trial, depending on where they fall in the drug development pipeline. These are:
Clinical trials must be carried out to extremely strict standards by law.
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:
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
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:
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 about DTU’s clinical trials.