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clinical-trials

Clinical research is absolutely vital to the healthcare industry. Clinical research involves people and there are two types: clinical trials and observational studies. The former is about observing people in a normal setting. It is about gathering data and comparing it over time to give us a better idea about a specific pharmaceutical or ailment. But what about clinical trials?

What Is a Clinical Trial?

A clinical trial is a research study that is aimed at evaluating behavioral, surgical, and medical interventions. It is a great way to find out if a new treatment, something such as a medical device, diet, or drug is effective and safe for use in humans.

Clinical trial tests include ways to diagnose a disease early, even before the appearance of symptoms. The clinical trial may look at how to treat those living with a chronic health problem or a life-threatening disease. It is ultimately a hands-on approach to diagnosing and recognizing the disease and the treatments that are created.

The Four Phases of Clinical Trials

Clinical trials, as dictated by the FDA, require three phases. There is a fourth trial after the FDA approval as well. Here are the phases of the typical clinical trial.

Phase 1. This is a test of experimental treatments on a small group, typically on healthy people. The group is anywhere from 20 to 80 people and is meant to judge the safety, correct dosages, and side effects.

Phase 2. More people are involved and the focus shifts from safety to effectiveness. This is about obtaining data on whether the drug works.

Phase 3. Further gathering of information about effectiveness and safety. Also involves hundreds of people or more. If the results are proven by the FDA to be positive, they will approve the device or drug.

Phase 4. This is for devices or drugs that have already been approved by the FDA. This is typically a clarification of the side effects that users experienced while using the device or drug in question.