Understanding the Phases of a Clinical Study
A clinical study can be a very important time for a business owner. During these studies, there are typically four separate phases. These studies are often used in clinical drug development to test the safety and effectiveness of a particular drug. The amount of time it takes to complete all four phases of a clinical study can last from months to years. There are also special rules that must be maintained during a clinical trial. For example, researchers using children must obtain consent from their parent or guardian. In this post, you will learn more information about the four phases typically seen in clinical trials.
- Phase I: This first phase in medical research studies is usually done on a smaller scale. In many cases, an experimental drug or treatment will be administered to 20-80 people for the first time. During a phase 1 clinical trial, the safety and risk of side effects will be monitored closely.
- Phase II: The second phase of a clinical trial will typically be administered on a larger group of individuals. This new group number typically ranges in sizes from 100 to 300 people. In this next phase, researchers will look closely at both the effectiveness and safety of the experimental drug or treatment.
- Phase III: The third phase of a clinical trial involves an even larger number of participants, typically in the thousands. Additional factors are often looked at during this phase of a clinical trial including comparisons between other medications. However, side effect potential and effectiveness is still closely monitored during this crucial clinical stage.
- Phase IV: This is perhaps the most crucial stage of a clinical study. In these trials, it will be determined if a product that has been released needs to be pulled from the market. Typically, data related to long-term effectiveness and side effects will be looked at during this phase. There will also be further comparisons made between said drug and other forms of treatment.
In closing, the phases of a clinical trial are crucial for ensuring a drug or treatment is safe for public use. Once phase IV has been completed, the company will submit an official application for their drug to be released to market.