How Clinical Trials are Run
All studies, looking at new treatments, or new uses for existing treatments, are designed differently depending on what is being researched – most now will include monitoring impact on quality of life – not just cancer response or side-effects.
Increasing patients are being included in clinical trial design – what to study?, how?, what is important to check for? Patient Reported Outcomes (also known as PROMS) and Patient Reported Experiences (also known as PREMS).
However, there are also strict regulations, that need to be followed, to ensure that all stages or ‘phases’ of a clinical trial can be run safely – for more information about these regulations and rules click here.
Clinical Trials are tested in various phases:
Involves a relatively small number of people – usually healthy volunteers, but some are run with people affected by a particular condition or disease.
Is used to find out whether a drug works, whether it’s safe and what the side effects are – this usually includes a few more people than are involved at Phase 1.
Phases 3 & 4
Involve larger numbers of people and are designed to assess how the treatment works, compared with existing treatments, while continuing to assess side effects and risks.
Each study has its own specific checklist for who can take part – this is called an eligibility criteria.
You can find out more information about whether a trial is suitable for you by checking this criteria, speaking with your specialist team and / or the research (Clinical Trial) team.