Clinical trials are an essential part of medical research. They allow researchers to determine whether a new drug or treatment is safe and effective for humans. But do you know how the clinical trials work? How do the researchers and the scientists conduct them?
In this post, we will share detailed information about the entire process of clinical trials. You will be able to go through the in-depth details about the process of the trials.
#1 – Closed Safety Testing
The first phase involves testing the new drug or treatment on a small group of healthy volunteers, usually less than 100 people. Researchers monitor for any adverse reactions or side effects. This helps determine appropriate dosages that are safe for humans. This is the first phase, with only a handful of participants.
#2 – Testing on More Participants
In the second phase, the drug or treatment is given to a larger group of participants who have the condition that the drug is meant to treat. Researchers determine whether the drug has any beneficial effects on the condition and look for short-term side effects. In this phase, all the data is collected, and the primary analysis is done to understand the efficacy. In this phase, the proper dosage of the medicine is determined, the experiments are stopped, and the actual trial begins from the next phase.
#3 – The Final Phase
The third phase involves large-scale testing on more than a few thousand patients with the medical condition. This phase aims to confirm the drug’s effectiveness, monitor long-term side effects, and compare it to existing treatments. Successful results allow the drug company to apply for approval.
#4 – Approval Process
As the phases of the trials are completed, the researchers compile all the data and analyze the same. The Big Data and AI technologies are used in the data analysis process. Once everything is done, the data is sent to the regulatory authorities for official approval. After a few days, the approval is provided, and the medicine is made available to the public.
Final Words
When we dive into the intricacies of clinical trials, the phases are more complicated than the reality. Fortunately, you can understand everything with all the information provided in simple language. Please use the comments section below if you have any doubts or need more information.
