Clinical studies (also known as ‘clinical trials’) help researchers test new medications and improve (or test new uses for) those that are already available. They do this by asking participants to follow strict dosing plans and then comparing the results.
In this way, researchers can answer questions such as:
- Does this investigational drug work?
- Does it work better than another medicine already available?
- Does it cause any side effects?
These dosing plans, study procedures and research objectives are explained in each study’s protocol. Many doctors, researchers, and other specialists review this protocol before the study begins to ensure it is well-designed to answer the research questions, and that the safety and rights of research participants are prioritized. However, the exact risks of a study can be hard to predict. Hence, participants must agree to a schedule of clinical visits and/or telephone appointments so that the study team can monitor their health and learn how their dosing plan is affecting them.
During clinic visits, the study team will perform a range of assessments and laboratory tests. These will differ from visit to visit but may include:
- Electrocardiograms (ECG, a painless recording of the heart’s electrical activity)
- Echocardiograms (ECHO, a painless ultrasound of the heart – to monitor for any heart-related side effects)
- Vital signs checks (heart rate, breathing rate, pulse and temperature)
- Blood tests
- Physical examinations
- Nervous system assessments
- Questionnaires about cognition, behavior, quality of life
Although there is no guarantee that you will experience any benefits from enrolling in a clinical research study, participation in this study will provide information about the investigational drug that may benefit others in the future, and may be useful to researchers developing novel therapies. Research studies are the only way to learn more about a specific condition and, possibly, future treatments.