Clinical Trials

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Clinical trials are carried out to check whether a suggested new therapy is as effective and safe as they claim. It is a vital part of clinical research. The outcomes of the clinical trials are analysed and shared so that the scientific, medical, and patient communities can get the benefit from this trial.

To understand the concept of clinical trials, read the following procedure that has been divided into four phases. To make a treatment eligible for approval, it is essential that the first three phases are successful.

It is the initial testing of a new treatment, drug, or clinical device. To make sure it’s safe, it is first tested on a small group of people. Research studies in the first phase often include treatments or drugs that have been already tested in only animals and received a positive result.

First Phase

This phase usually involves a bigger group of people to estimate the safety of the intervention further and check its efficiency. This generally includes two group – the first group of people receive the trial treatment or drug, while a second ‘control’ group will get standard treatment. These studies are often double-blinded.

Second Phase

Third Phase

This phase evaluates the efficacy of the intervention in a bigger group of people, which can be up to several thousand people. Here, comparisons are made against other similar treatments for the identical condition, while observing for objectionable effects. Once the study is completed in the third phase, regulatory approval can be received for the drug or a specific therapy so that it can be used in clinical practice. Sometimes for regulatory approval, more than one third phase study is required.

Fourth Phase

Once a new drug or treatment has received regulatory approval and it is allowed to use, further research and studies are performed to analyse the effectiveness and gather more information to check if there are any objectionable effects. Late third and fourth Phase studies are often compared to see how successfully it’s working.

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