Clinical trials basically research medical studies performed in the individuals that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the sole way that researchers find out if a new treatment, like a new drug, new vaccine, injection, or diet, or medical device, is safe and effective in people or not. A clinical trial is mostly used to learn if a new treatment is more effective and has slight harmful side effects than the standard treatment used at present.
Other clinical trials are performed to test different ways to find a disease early, sometimes before there are symptoms seen even. A clinical trial may also examine how to make life better for people living with a life-threatening or acute disease or a chronic health problem.
Clinical trials go through four different phases to examine a treatment, find the right amount of dosage, and analyze if any side effects are present. Suppose researchers analyze a drug or another intervention that is seen to be safe and effective after the first three phases. In that case, the FDA approves it for clinical use and continues to monitor its effects later on.
Clinical trials are usually categorized based on their Phase. The FDA generally requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
- Phase I trial mainly tests an experimental treatment. This is done on a small group of often healthy people (20 to 80 people) to judge its safety and side effects and find the correct drug dosage.
- A Phase II trial requires more people (100 to 300 people). While Phase I is based on safety, the focus in Phase II is on the effectiveness of the dosage. This Phase aims to check whether the drug is working in people who have a certain disease or condition or not. These trials also examine safety, such as short-term side effects. This Phase can last up to 2-4years, to say the least.
- A Phase III trial collects more information about safety and effectiveness and aims to check on diverse populations and different dosages, using the drug in combination with other drugs. If the FDA approves that the trial results are positive, it will approve the experimental drug or device.
- A Phase IV trial is lastly for drugs or devices that take place after the FDA approves their use. A device is monitored in large on diverse populations. Sometimes, a drug’s side effects may not become clear until more people have taken it over a longer period of time.
