Clinical trials are carefully planned research studies. Sponsors of clinical trials include companies, universities, or healthcare institutions who initiate and support the research.
In clinical trials, scientists research and evaluate medicines and their effects on healthy people or those who are dealing with a particular condition. The people who participate in clinical trials are dedicated volunteers.
Doctors who are trained in conducting clinical trials are the principal investigators. They carry out the research and interact with study participants. There are other members of the research team that also help to coordinate the trial.
Before each trial begins, there is a strict plan that is established. This plan or protocol includes:
- What is known about the disease and the medicine in the study
- Why is the study being conducted and what question(s) will be answered
- What tests and procedures will be performed
- The study design and methods to test the questions being asked
- How often study participants will be examined or evaluated
In addition to clinical studies, observational studies may also take place to help investigators observe and evaluate a specific question or health outcome in human participants. Participants may receive medical products such as drugs, devices, or procedures as part of their routine medical care. However, the participants are not assigned to specific interventions by the investigator (as in a clinical trial).