Studies and trials
Great Minds volunteers may be invited to join either a research study or a trial, but what does this mean? Below is a brief description of what you might expect if you join a study or a trial.
Clinical trials are studies that involve testing an intervention. Interventions could be in the form of a new drug, an already licensed drug used in a different context (see below) and also treatments involving a change in lifestyle, for example diet or exercise.
In observational studies, researchers are interested in collecting a lot of information about participants, which will be used to formulate hypotheses about the onset or course of a disease. This information is essential for future clinical trials. Observational studies can include medical assessments (for example, physical examinations and blood or urine samples) but also questionnaires and memory and thinking tasks.
In questionnaire-based studies, you will only be asked to fill in questionnaires. This can be either online or in person, depending on the study.
Clinical trials: drug trials
Some drug trials are designed to test a newly developed drug, and others to test an existing drug for the treatment of a different condition. There are four different phases of drug testing in humans:
- Phase I – Testing the safety and mechanisms of a drug on a small number of healthy volunteers.
- Phase II – Testing the efficacy and side effects of a drug in healthy volunteers and patients. These trials are often randomised and involve a treatment and a control group. The control group does not receive the drug but receives a standard treatment or a placebo. Participants are usually not aware if they are in the treatment or control group.
- Phase III – Testing the effectiveness, side effects and range of effects on large groups of volunteers and over a longer period of time.
- Phase IV – Continued testing of a drug once it has been licensed.
Volunteers for drug trials are given extensive information about all aspects of the trial, including information about the drug and procedures. Volunteers can choose whether to take part or decline the trial based on this information. The information explains the risks of taking part in a drug trial and researchers work to strict guidelines and regulations to ensure the participants' safety.
Drug trial volunteers usually provide samples during the course of the trial, for example blood and urine. This monitors volunteer safety and the effects of the drug on the volunteer.