A clinical trial, also called a research study, can be many things. They can mostly be categorised as:
- An observational study. This is usually when a researcher is specifically observing the effects of a course of treatment.
- An interventional study. This is when a researcher provides a course of treatment to a patient. This could be medicine, performing specific procedures or using new devices or equipment.
Stage 1 – A clinical trial is designed by the researcher and then authorised by its sponsor (the organisation which allows the study to occur) and by the local research ethics committee. Once this permission is received, it can then be ‘set-up’ where the study will be delivered.
Stage 2 – The next stage is the ‘recruitment’ stage. This refers to when a patient is approached by a member of the research team and asked if they would like to take part in the study. This is called ‘Consent’. Once consent is taken, the patient is then called a ‘Research Participant’. Depending on the rarity of the condition, this stage of the study could take several years as each study has a number of patients – a target – that they will aim to recruit.
Stage 3 – When a study becomes closed to recruitment, it then goes into its ‘follow-up’ stage. This is where all of the data is collated and the findings of the study are confirmed.