Clinical trials are essential for developing new medications and treatments. They test the safety and effectiveness of new drugs before they become available to the public. Understanding the different phases of clinical trials helps in appreciating the rigorous process involved in bringing new therapies to the public.
There are roughly four phases of the clinical trials and all of them are conducted with a different purpose. In this post, we are going to explain the aim of these various phases of clinical trials.
#1 – First Phase
The first phase of clinical trials focuses on assessing the safety of a new medicine. Researchers administer the drug to a small group of participants not more than 100 at a time.
During this phase, researchers find out the best dosage by gradually increasing the amount given to participants. They also monitor for any side effects. Once identified, the researchers then move to the second phase.
#2 – Second Phase
Once the first phase is completed, the researchers start the second phase, which involves a larger group of participants. The aim of this phase is to assess the effectiveness of the medicine for the medical condition. The participants in this phase usually have the health condition for which the trial is being undergone.
The researchers administer the safe dosage to the participants and monitor their health metrics. This helps researchers understand the working mechanism of the medicine. Once the effectiveness of the medicine is confirmed, the researchers now move to the third phase.
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#3 – Third Phase
The third phase is actually the final phase of the active trial. In this phase, a huge group of participants is included. As the participant group is quite huge, this phase helps researchers identify the effectiveness of the huge number of people, identify the side effects, and also compare the results with the existing treatment options.
During this phase, researchers get more comprehensive data to understand the drug’s benefits and risks. This phase makes it easier to collect the data and come to the actual conclusions.
#4 – Final Approval
After completion of the third phase, the researchers submit the report to the regulatory authorities. After that, the regulatory authorities analyze the same and provide the final approval. This is a lengthy process as the authorities analyze minute parts of the data and then make sure if the medicine or treatment option is safe or not.
Final Words
The phases in the clinical trials are very essential to smoothly conduct them and have actionable results. With these four phases, the researchers can get to the conclusion without any issues and get the final approval from the authorities to make it to the post-market survey part.
In this post, we tried our best to share detailed information about the various steps of the same. If you have some questions, feel free to ask some questions below.
