What are Clinical Trials?

A clinical trial is a research study used to validate a new treatment or therapy in volunteers young and old. Through these studies, and by conducting them in controlled environments, researchers and medical professionals can determine if a treatment is safe and efficacious, and how it can be used to treat a specific disease or condition. For these reasons, clinical trials are a vital component in the advancement of medicine.

Clinical Trial Phases

Clinical trials are conducted in different steps, or “phases.” As explained below, each phase serves a specific purpose in the treatment development process.

Phase I

Phase I studies are used to determine the safety of a treatment in participants, and also study how the treatment interacts with the body. Phase I studies help create a foundation for the drug upon which future studies can build on.

House foundation with walls illustration

Phase II

Phase II studies are used to test a treatment’s effectiveness, while continuing to monitor any side effects that may occur. Once this phase is complete, researchers have a better idea about what the future of the drug will look like, how it will work, and who will be able to use it.

Phase III

Phase III studies validate the effectiveness of the treatment and allow researchers to determine its safety and efficacy. In some cases, Phase III studies may take place after a treatment has been approved by the FDA.

House illustration indicating someone is living inside of it

Phase IV

Phase IV studies are used to test a treatment’s effectiveness in a real-world setting, after it has been made available to the public. These studies gather additional information about the treatment, including benefits, risks, and its effect on quality of life.

Who is Involved in a Clinical Trial?

The Sponsor

Trials are funded by pharmaceutical companies, medical centers, voluntary groups, or other organizations and/or individuals.

The Site

Clinical trials can be conducted in various locations including hospitals, universities, clinics, or doctors’ offices throughout the country.

The Principal Investigator

The principal investigator is the researcher or healthcare professional who leads the study and who heads the research team made up of doctors, nurses, and other healthcare professionals.

The Study Coordinator

The study coordinator works closely with the principal investigator and oversees the research team and the participants throughout the study.

The Participant

A study participant, also known as a patient or a study subject, is anyone who provides consent to be in the study. This could mean you or your loved one.

Ethics Review Boards

This group of individuals reviews and monitors the study to ensure that the volunteers who participate in the study are protected and treated fairly.