Clinical trials are a journey, and like any journey, they have several stages or phases. Each phase has a different purpose and helps researchers answer different questions. Let’s explore these phases one by one.
Phase I
The first phase of clinical trials, aptly named Phase I, is all about safety. In this phase, a small group of people (usually 20-80) receive the trial treatment for the first time. The goal is to identify any side effects and determine the treatment’s safety. Researchers also try to find the best dose that can be given without causing severe side effects.
Phase II
Once the treatment has passed the safety test, it moves on to Phase II. In this phase, the treatment is given to a larger group of people (usually 100-300) to see if it is effective and to further evaluate its safety. Researchers monitor the participants closely to see if the treatment works and if there are any side effects.
Phase III
Phase III is where things start to get serious. In this phase, the treatment is given to large groups of people (usually 1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the treatment to be used safely.