Who can join
Who may be able to join based on their age, sex, health, or other criteria
A clinical trial is a research study where volunteers agree to participate in a project to test an investigational medication.
The trial is designed to discover whether this investigational medication works, if it is safe, and what the side effects are. It’s only through clinical trials and the help of volunteers like you that important questions about investigational medication can be answered.
*Please note that there is no guarantee that the investigational medication will be approved by the FDA. The safety/efficacy of all investigational products have not yet been established.
Are clinical trials safe?
Strict rules about how to run a clinical trial were put in place to protect the safety, well-being, rights and privacy of trial volunteers.
How are clinical trials set up?
Every trial has a detailed plan, called a protocol. The protocol explains why the trial is being done, who can take part, and how the trial will be conducted. It typically includes:
What happens
The study medicine, tests, procedures, and visits you may have
Staying safe
How the study team will check for side effects and follow safety rules
Study goals
What researchers want to find out and how they will measure the results
Before the trial can start, an Institutional Review Board (IRB) and the appropriate health authorities must approve this plan.
Keep in mind, clinical trials will only take place if there is a scientific and medical reason for the trial. There might be both potential benefits and possible risks for participants.
The 4 phases of clinical research
Before a medication can be tested in a clinical trial, it must first be tested in animals to confirm that it is safe for testing in people. Then, the investigational medicine is studied through the following 4 clinical phases:
Phase I
Basic safety
Phase I trials test the safety of a study medicine in a small group, sometimes including healthy volunteers. If it is considered safe enough, testing may continue in Phase II.
Phase II
Does the investigational medication work?
Phase II trials test how well a study medicine works in a few hundred people with a specific condition. Researchers also continue to monitor its safety.
Phase III
Testing in a larger group
Phase III trials test a study medicine in hundreds or thousands of people with a specific condition. It is compared with the usual treatment or a placebo. Often, neither the participant nor the study doctor knows which treatment is given.
Phase IV
Post-approval testing
Phase IV trials study an approved medicine in hundreds or thousands of people. They help researchers learn more about its long-term safety and use in everyday care.
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Participant Experience
