Clinical Trial Research Aimed at Assessing Behavioral, Surgical, and Medical Intervention
Clinical trials research are studies that are carried out on people. They are usually aimed at the evaluation of behavioral, surgical, and medical intervention. For example, there are different ways that researchers apply clinical research to discover something new about a medical device, diet, or even drugs. Others aim at identifying diseases as early even before any symptoms are evident. They are used to find ways in which health problems can be prevented. Additionally, clinical trials may also be conducted to find ways in which life can be better for persons who are living with diseases that are life-threatening or people with chronic health issues.
What is done before approval?
Before any clinical trial research is approved, laboratory tests have to be conducted by qualified scientists.
Studies are first done on animals subjects. This is done to test the therapy’s potential efficacy and safety. If favorable results are achieved, then the necessary regulatory body can give approval for it to be tested on human subjects.
The phases
The advancement of clinical trials research covers different phases to understand the dosage and identify side effects. When these four phases are complete and the drug or device is seen as favorable, then it receives approval for mass use. However, researchers will continue monitoring the product even after it is introduced in the market.
During phase one, tests are done on healthy people, but in a small group to find the correct dosage, and side effects.
The second phase involves more people and this time the aim is to find the treatment or device’s effectiveness. It offers data on whether a condition or disease can be combated by the drug.
The third phase is about effectiveness and safety. Different dosages and different populations are tested. The drug can be combined with others to see how that impacts the body. This is the point where the product gets FDA approval.
In phase four, after approval, the safety, and effectiveness of the device or drug are tested on a more diverse population for long term effects and monitored after it goes on the market.
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