A clinical trial is a way of trying out the safety, as well as the benefits, of experimental medication that is in development. We are trying to see if this medication is something that could help patients with certain diseases.
Clinical trials have four phases. Phase I trials test the safety of a new medication. By Phase III, trial participants are adults who have the condition, disease or symptom that medication is being developed to treat.
The only way that new medications—meds that are more effective, maybe safer—will be approved for the public is if people participate in clinical trials.
This short and informative video will give you an overview of clinical trials.
Participants are typically adults with a specific condition, disease or symptom that the investigators are trying to study.
You also have to meet the enrollment criteria for that trial.
Clinical trials can have several benefits for the participants.
One benefit is that you can get access to a drug that’s not yet available to the public. Sometimes that can be as early as three or four years before it ever comes to market.
Another benefit is that you get extensive testing while you are participating in clinical trials. You get access to EKGs, cardiac monitoring and brain scans—and typically at no cost. You can also be monitored for longer periods of time than in a typical office visit.
You can also get safe access to medications not yet in market at no cost. And oftentimes, you can continue on the meds until the medication comes to market.
These definitions will help you understand the various stages of research, and the steps that a drug must go through before it is approved for use by the Food and Drug Administration (FDA).
Clinical Trial
A clinical trial is a research study designed to test the safety and/or effectiveness of drugs, devices or treatments in humans.
Clinical trials can usually be divided into four categories or "phases" that a drug must undergo before it can be approved by the FDA.
The four phases must be completed in order, and positive results must be obtained before moving to the next phase.
Phase I
This is the first of four stages of clinical trials in humans. In Phase I studies, the experimental drug is usually given to a small group (20-80) of healthy volunteers.
The purpose of a Phase I study is to gather information on safety.
Phase II
A Phase II trial involves a larger number of participants (100-300) who usually have the disease for which the experimental drug is being tested.
The purpose of this phase is to gather additional information on safety and effectiveness. Often these studies are "blinded" - neither the patients nor the researchers know who is getting the study drug.
About one-third of experimental drugs successfully complete both phase 1 and phase 2 studies.
Phase III
The third stage of testing involves large numbers of patients (1000-3000) who have the disease for which the experimental drug is being tested.
This stage of testing usually compares the experimental drug to the current approved treatment for the disease.
An application to approve the experimental drug can be submitted after this stage of testing.
Phase IV
This stage is performed after the drug has been approved by the FDA.
In Phase IV, studies are done to compare the drug to a competitor, examine the long-term effects of the drug, or look at the drug in new types of patients.
What is a Placebo?
A placebo is an inactive pill, liquid or powder designed to resemble the treatment being tested.
It is used as a control to measure any psychological effects testing may present.
Most studies compare a placebo with the treatment drug to assess its effectiveness.
EvergreenHealth Research Services was established in 1989, and is comprised of a sophisticated and cross-trained hub of high achieving research professionals.
The program's growth and expansion has been supported by EvergreenHealth Medical Center, with the overarching goal to make clinical trial opportunities available to our community.
Our clinical trial partners include the EvergreenHealth Neuroscience Institute, EvergreenHealth Heart and Vascular Care and Fred Hutchinson Cancer Center.
Policy: Research Conflict of Interest (PDF)
