Always wanted to know what is a clinical trial. and this article more clear answer to my question. Clinical research is a scientific and rigorous work, I hope the researchers in the field of muscular dystrophy, as soon as possible to bring good news.
What is really a clinical trial?
If a clinical research review involves testing or studying a drug or healthcare device to see if it is really a safe and effective treatment for people, it is called a “trial.” For example, a clinical trial might test the effectiveness of the new drug for treating Parkinson’s disease.
Many new medicines and prescription drugs are found to work in the researcher’s lab, and for being safe and effective in animal tests. But prescription drugs and products must be proven for being safe and effective for people before the meals and drug administration (FDA) can approve them and doctors can prescribe them to patients. The FDA has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.
What are clinical trial “phases?”
Clinical trials of experimental prescription drugs proceed via four phases:
In period I clinical trials, researchers test a brand new drug or treatment with the first time in a small group of normal, healthful volunteers (about 20 to 80) to evaluate its safety, determine a safe dosage range, and determine facet effects.
In period II clinical trials, the review drug or treatment is provided to some larger group of people (about 100 to 300), such as patients using the particular disease, to see if the drug or treatment is effective, and also to further evaluate its safety.
In period III clinical trials, the review drug or treatment is provided to large groups of people (from 1,000 to 3,000), such as patients, to confirm its effectiveness, monitor facet effects, assess it to other commonly used treatments, and gather information that will enable the drug or treatment for being used safely.
Phase IV clinical trials are performed after the drug or treatment have been approved through the FDA and marketed for community use. These experiments continue testing the drug or treatment to gather information about its effect in several populations and gather data on any facet effects related to long-term use.