At any given time, there are hundreds of clinical trials being conducted on new MS treatments. Each of these trials is in different stages and examines different factors of MS.
What is a clinical trial?:
A clinical trial is a carefully controlled test of a medication. A clinical trial has two main goals. These are to determine a medication’s:
- Safety: The clinical trial must prove that the new medication is safe for use in people.
- Effectiveness: The clinical trial must prove the effectiveness of the new medication.
A new medication goes through a series of testing phases before it can be approved for the general population:
Phase I Clinical Trial:
A phase I clinical trial’s main purpose is to determine the safety of the medication. A small number of volunteers are given the new medication and carefully monitored for reactions and side effects.
Phase II Clinical Trial:
Phase II trials are designed to investigate the effectiveness of the new medication. These trials have a larger number of people. Some of the people are given the treatment and others are given a placebo or other medication. Researchers compare the responses of the group given the new drug to the group given a placebo or other medication to determine if the new drug is more effective.
Phase III Clinical Trial:
A medication that has passed through the Phase I safety trial and the Phase II effectiveness trials moves into the Phase III trial. In this trial, hundreds of volunteers are given the new medication, often in different locations and for a longer time period. These trials are used to determine the potential side effects of the medication, the long-term effects and any complications that may occur. After a drug has passed through a Phase III trial, an application for FDA approval can be made.
Phase IV Clinical Trial:
A phase IV trial is sometimes conducted after FDA approval in order to determine effectiveness and long-term benefits of the drug in a much larger number of people.
While learning about MS clinical trials you may have a few questions and run across some unfamiliar terms. Below is a list to help you further understand MS clinical trials: