Clinical trials are a way to test new methods of diagnosing, treating, or preventing health conditions. The goal is to determine whether something is both safe and effective.
Keep reading to learn more about what happens during each phase. For this article, we use the example of a new medication treatment going through the clinical trial Los Angeles process.
PHASES OF CLINICAL TRIAL:
PHASE ONE:
During phase I of a clinical trial, investigators spend several months looking at the effects of the medication on about 20 to 80 people who have no underlying health conditions.
This phase aims to figure out the highest dose humans can take without serious side effects. Investigators monitor participants very closely to see how their bodies react to the medication during this phase.
While preclinical research usually provides some general information about dosing, the effects of a medication on the human body can be unpredictable.
PHASE TWO:
Phase II of a clinical trial involves several hundred participants who are living with the condition that the new medication is meant to treat. They’re usually given the same dose that was found to be safe in the previous phase.
While phase II involves more participants than earlier phases, it’s still not large enough to demonstrate the overall safety of a medication. However, the data collected during this phase helps investigators come up with methods for conducting phase III.
PHASE THREE:
Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.
The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.
To do this, investigators use a process called randomization. This involves randomly choosing some participants to receive the new medication and others to receive an existing medication.
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