The extent of the clinical trials is very huge and that’s why they have to be conducted in multiple phases. Be it the interventional trials or the randomized trials, everything has to be conducted in a phased manner. Usually, there are four phases of the trials and the phases can increase as per the necessity.
But what is the significance of the phases of clinical trials? What do researchers do in these four phases of clinical trials? If you are curious, then you are at the right place. In this post, we are going to share everything about the different phases of the drug trials.
The first phase of the trial is important as the researchers try to recruit the patients. There are numerous ways to recruit the participants, and the researchers will do everything possible. Once the recruitment is complete, the actual trial phase will begin. The researchers will now start administering the experimental medicine in smaller dosages to identify its safety. Once administered, the researchers will monitor the patients for any adverse effects.
The second phase is what makes or breaks the trial. In this phase, researchers will keep increasing the dosage of the medicine to identify the safe dose limits. After that, the researchers will make sure to identify the safety and efficacy of the same. In this phase, more participants are included for a better understanding of the efficacy and safety.
The third phase runs for a long time and has more than a few thousand participants, depending on the aim and the complexity of the trial. In this phase, the researchers test the drug on a huge number of participants to understand its safety and effectiveness in different demographics. In this phase, the researchers collect all the data to analyse, arrive at a conclusion, and prepare for regulatory approval.
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The fourth phase is the final phase and the most time-consuming one. In this phase, the researchers analyse all the collected data, create a report and then submit it to the regulatory authorities for final approval. The regulatory authorities will now check everything and then provide the final approval to make medicine available to the public.
The Phases of Clinical trials play an important role in managing the trials most conveniently. In this post, we tried our best to explain everything in detail about the various phases of clinical trials. If you still have some questions in your mind, feel free to ask them in the comments section below.
