The clinical trials are very important for humanity as they bring the new medicines to the market. But that’s not an easy endeavor as researchers have to conduct the various phases of the same. This is done to assess the safety and effectiveness of the medicines. This is quite important as without identifying the safety of their medicine, it cannot be administered to a large number of groups. But how do researchers determine the safety and effectiveness of the new groundbreaking medicines?
#1 – Preclinical Testing
Before human testing begins, researchers conduct preclinical testing. This stage involves laboratory experiments and animal studies to gather initial data. Researchers assess the potential effects of the new medicine, looking for any harmful side effects.
Animal studies are essential during preclinical testing. These studies help determine the safe dosage for the animals and then continue with the different phases of trial with actual humans.
#2 – Phases of Trials
Once the preclinical testing is completed and the approval for the human testing is obtained, the researchers start the various phases of the actual trial. There are three to four phases of the trials that are conducted to identify the safety of the medicines.
In the first phase, researchers get a few hundred participants and then administer the safe doses to them. Once administered, the researchers keep a keen eye on their health vitals to identify if the medicine is safe or not. They also keep increasing the dose gradually to identify the safest dose and then proceed to the next phase.
The second and third phase focuses on identifying the effectiveness of the medicine. If the medicine is working properly on the said condition, is it having some weird unaccounted reactions, is it being accepted by the body and even checked if it’s causing any ancillary reaction?
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#3 – Regulatory Approval
Once the researchers conclude the tests and confirm the safety and efficacy of the medicine or the treatment option, they have to prove that to the Regulatory Authorities. Each country or union has different authorities that provide approval. So, the researchers have to work on collecting all the data and submitting that with a comprehensive report for additional testing and then provide the final approval. The medicine or treatment option can be made public only if it receives final approval.
Final Words
Medicines and Treatment options cannot be made available to the public unless and until the safety and effectiveness of the same can be proven. With the clinical trials, the researchers take the ultimate precaution of making sure the medicines and treatments are safer than ever. In this post, we tried our best to explain everything about the ways researchers and doctors conduct the trials for safety and effectiveness. If you have some questions in your mind, feel free to ask them in the comments section below.
