How are new treatments approved? - PRC

How are new treatments approved?

Before a new treatment can be prescribed to a patient, it goes through quite the journey. It starts in the lab, with so-called pre-clinical trials (before human testing) during which scientists carefully study the potential new drug. If the results of these pre-studies are promising, the investigational drug begins the clinical trial process where its effects are studied in people. These volunteers (sometimes called participants or patients) may receive specific study drugs, a placebo, or an already approved comparator drug, and complete various assessments and clinic trial visits.
Each clinical trial follows a carefully-designed research plan called a protocol, which has been approved by groups of medical professionals and specialists to protect participants’ safety and health. All clinical trials we run with our physician partners meet international standards and guidelines.
Clinical trials are usually conducted over four phases.
Phase I
This is the first time an investigational drug will be tested in people, and often involves a small group of healthy volunteers – about 10 to 30 people. Here, we are trying to understand how the potential medicine interacts with the body and if there are any side effects.
Phase II
Phase II clinical trials aim to understand how safe and potentially effective an investigational drug is for people with the condition it hopes to treat. This phase often compares the investigational drug to a placebo and usually involves between 100 and 200 participants. These trials help us understand if the investigational treatment has any effect on the condition itself.
Phase III
In Phase III clinical trials, the potential treatment is monitored in even more volunteers, likely several hundred or even several thousand. This is an important step in the development of a potential medicine because its aim is to gather more information about the effectiveness and safety, and how it compares to already-approved treatments. This phase can run for several years and might take place at many research sites around the world.
Phase IV Trials
Once a potential treatment has been successfully approved by the Food and Drug Administration (FDA) and is available to the public phase IV trials are conducted. Phase IV trials take place in the “real world” rather than at a clinicalstudy site, and researches any long-term effects the treatment may have.