The Different Stages of Clinical Development

Often, we post stories on our social media pages that outline potential new multiple sclerosis therapies in different phases of clinical development. Here, we discuss what happens at each phase in the process from designing a drug to getting it approved for use:

Phase I – The safety of the drug is tested in a small group of people. The best dosage range is identified and any side effects observed.

Phase II – The effectiveness of the drug is tested in a larger group of people with side effects monitored.

Phase III – The drug is tested on a larger group of people again to test effectiveness and monitor side effects. It is often compared to existing treatments during this phase.

Phase IV – Studies are done to evaluate any long-term safety issues and the effectiveness of the drug in different populations.