Clinical trials are crucial to ensure that treatments are safe and effective.
These research studies test the safety of new medical approaches, including the development of new medications and devices (and even combination products such as stents that release medication!).
Clinical trials follow a protocol which is an action plan for the study. The protocol describes:
- what the study entails
- how it will be conducted
- why each portion of the study is necessary
Depending on what is being studied, each clinical trial will have different requirements for participants. Some require volunteers with particular diseases while others require healthy people. For example, age, sex, medication history, and more can be determining factors (or inclusion/exclusion criteria) for a clinical trial.