How A Phase 1 Clinical Trial Works and How You Can Help Save Lives

Your health is valuable not only to you, but to your loved ones as well. In a world that seems to always be fighting over one thing or another, it is good to know that there are people working to help save lives instead of those determined to take them away. A clinical trial is the process used to determine how a new drug may work. These trials are typically broken down into different phases to make sure that each level is given the proper amount of time and care to ensure the safety of the people testing it and the people who may use the drug in the future. A phase 1 clinical trial is the first one to involve the use of actual people. Before a phase 1 clinical trial, a phase 0 trial poses the question of how will the drug effect people.

Clinical drug development is important to ensure that people are getting the care they need for their various illnesses. Medical research studies show that a clinical study is the best way to see how well these drugs will work. Most people are unfamiliar with the process, but once it is explained, it is easy to understand. In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20?80) for the first time. The purpose is to evaluate its safety and identify side effects. In Phase II trials, the experimental drug or treatment is administered to a larger group of people (100?300) to determine its effectiveness and to further evaluate its safety. In Phase III trials, the experimental drug or treatment is administered to large groups of people (1,000?3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely. After completing Phase IV, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000-10,000 drugs that annually enter RandD, only 250 make it to pre-clinical trial testing; only five make it to clinical trial testing; and only one makes it to FDA approval.

Clinical trials are important, but not many people participate. According to a survey about clinical trials in the U.S., some 96 percent of respondents never participated in a clinical trial. It?s our job to help make the world a safer place. Go out and sign up for a phase 1 clinical trial today.