Clinical trials are super important for finding new treatments and making sure they’re safe and work well. The process of testing a new treatment has different steps, each with its own goals and challenges.
In this post, we will explore the world of clinical trials and understand the various phases that researchers follow to complete clinical trials with human subjects.
#1 – First Phase – Identifying Right Dosage Amount
First things first, in Phase 1, scientists want to see if the new treatment is safe and figure out the right amount to give people. They start with a small group of participants who carefully test the treatment regime or certain medication. The researchers and scientists then observe the patients, get their vital medical information, and perform numerous checkups to complete the assessment. If required, the doctors adjust the dosage accordingly and then proceed to the next phase if the appropriate dosage amount is identified.
#2 – Second Phase – Testing with Bigger Group
In Phase 2 of clinical trials, researchers want to check if the treatment works for people who actually have the health condition it’s meant for. A larger group of participants is invited to the trials, and they are given the specific medication or treatment regime. Researchers keep a close eye on how well the treatment works and what side effects show up.
This helps the researchers to understand the efficacy of the treatment regime for the participants who have actual diseases or medical conditions. This is quite an interesting phase as there are a lot of adjustments done in the medication if the patients see any kind of side effects. If no side effects are observed, then the trial proceeds to the next phase.
#3 – Third Phase – Inviting a Large Group
The third phase is the longest phase, as a huge number of people are invited to the trials. If allowed, this phase is usually conducted globally or within the country. In this phase, more than a few thousand participants joined this phase and received the trial treatments.
This phase is considered the pre-finalization phase, in which the participants receive a near-final variant of the medication or treatment. After this phase, the entire data is sent to the governing authorities, and approval is sought.
#4 – Fourth Phase – The Final Step
The fourth phase is the final stage of the clinical trials. In this phase, the researchers share all the data with the governing authorities and ask for final approval. The approval is provided after the authorities do a proper check of the medication, patients, and the collected data.
This phase may last longer than expected, as the authorities will scrutinize every bit of data provided by the researchers. Once approved, the medication or treatment regime can be produced in bulk and provided to the patients.
As the clinical trials are meant to provide a safe and effective medicine for the patients, the trials have to go through multiple phases. Each phase has its own importance, and the researchers do it to get accurate researchers. In this post, we tried our best to explain about these phases.