Phases of clinical trials

THE HANS INDIA |   Jul 10,2018 , 03:13 AM IST

Phases of clinical trials
Phases of clinical trials

Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions. Saying so, https://www.fda.gov provides definitions of four types of trials as under: 

Phase I trials: Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects. 

Phase II trials: The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III trials: The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. 

Phase IV trials: Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

Examples of other kinds of clinical research: Many people believe that all clinical research involves testing of new medications or devices. This is not true, however. Some studies do not involve testing medications and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to results of people with the illness being studied, according to the US FDA website. 

The US FDA, and its corollary agencies abroad, requires that a potential therapy’s safety and efficacy be tested extensively in a large group of human volunteers before it can receive approval to be manufactured and made available to patients. Yet clinical testing can — and often does — fail because not enough people volunteer. This lengthens the time it takes for new treatments to come to market. 

No amount of funding or other resources can compensate for the lack of clinical research volunteers. That’s why volunteers can play a truly unique role at this pivotal stage of drug development, which is crucial for new treatments to reach pharmacy shelves, says https://foxtrialfinder.michaeljfox.org.



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