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Clinical research is the ‘backbone’ of progress in healthcare. Behind every modern medical treatment are people who took part in clinical trials to find out if the medicine was safe and if it worked.

Clinical trials are research studies in which people volunteer to receive medical interventions including medicines, cells, or other biological products, surgical or radiological procedures, devices, behavioural treatments, or preventive care, to help answer specific research questions according to a protocol provided by the trial sponsor.

If you want to know more, you can look at this video:

What is a clinical study protocol?

Any trial must be conducted according to international and regional ethical principles that have their origin in the Declaration of Helsinki, and to scientific, regulatory and quality standards consistent with international Good Clinical Practices. Every clinical research trial sets out to answer a particular question which is made clear at the start. People can participate in the study only if they have been fully informed about how it will be set up and run, what its benefits and potential risks are, and after having signed an informed consent form. All of this is summarised in the protocol.

What are the four phases of a clinical trial?

Who participates in a clinical trial?

A key consideration with all clinical trials is to figure out in detail what type of participants can join.  For example, it may be important that the participants don’t have a form of the condition being studied that is too severe or too mild. The requirements that describe whether a person can or cannot join a trial are called ‘eligibility criteria’. A process called ‘screening’ is used to work out whether each person who is considering joining the trial meets all the eligibility criteria.

Joining a clinical trial is always voluntary. Some people choose to join if the trial offers the chance to receive a potential new medicine that is not yet available for doctors to prescribe.

When planning a trial, the sponsor will need to make sure that enough people take part.  It is important that clinical trial participants properly represent the type of people who will ultimately receive the intended new treatment in routine practice. Participant recruitment and diversity are a challenge in clinical trials.

By moving clinical studies – or elements thereof – to participants’ homes, studies can be made more accessible. These so called Decentralised Clinical Trials (DCTs) or trials with remote elements hold the potential of solving some challenges, for example: participants no longer need to visit the hospital for study-related activities, or at least not that often.