Clinical Trials & It’s Phases

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What Are Clinical Trials?

In Clinical Trials, people take part as a volunteer. The primary way of this study is that researchers found out whether new treatment (like drugs, new diets), biological products, surgical procedures, radiological procedures and medical devices is safe and effective in people or not.

Clinical trials try to make people’s lives better with a life-threatening disease. e.g Clinical Trials for SARS-CoV-2 Vaccine (Covid-19).

Why Do We Need Clinical Trials?

Clinical Trials are extremely important for the development of new treatments and diagnostic tests. Without clinical trials, we cannot determine whether new drugs or treatments are effective, safe, reliable or if diagnostic treatments work properly or not. Clinical Trials are the best way to observe what work has to be done in treating diseases like Cancer.

Clinical Trials are designed to find out the answer to some problems:

1. For New Treatment: clinical treatment is important because the doctor has to check whether the new treatment is working well or not. They check that is it better than the treatment which is being used currently. During clinical trials, doctors also check the causes and side effects of the new treatments. Apart from this doctors also check new treatments in those patients who are not being affected by current treatment.
2. Safety of new treatment: In clinical trials, doctors check the efficacy of the new treatment.
3. Clinical trials are also important to check that new treatment is better than the standard treatment of diseases and with the help of the clinical trial, doctors check the new drugs or new treatment combination works well what treatments they are using now.

Phases Of Clinical Trials :

What Happens in Different Phases Of Clinical Trials?

Once the clinical trials get approved then it requires different phases to conduct clinical trials. Each phase or step is designed to keep in mind that patients or subjects should be safe. Surety of patient safety and accurate result of clinical testing is also important.

Pre Clinical Phases

Investigators conduct the preclinical phase before starting clinical trials. In the preclinical phase they human cell culture or animal body. The preclinical phase is also known as Phase 0. In Phase 0 very small number of subjects participate usually from 10 to 15. Investigators use a very small dose of medication in this phase. By this phase, the investigator ensures whether this medication is safe for humans or not.

Phase-1:

In this phase 20-80 subject participates. While conducting clinical trials in phase 1 investigator spends several months for phase 1 clinical trial. The aim of this phase is to find out can humanly take a higher dose of medicine without serious side effects? The investigator monitors subjects in this phase to see how their bodies are reacting to the medication. To evaluate the safety and ideal dose investigator administered drugs intravenously.

FDA estimates 70% of medications go into phase II.

Phase-2

In phase-2 100-300 subjects participate and it takes up to 2 years. In this phase, those subjects participate who are living with the condition that the new medication is meant to treat. Investigator gives the same dose in this phase which was found safe in the first phase.

The investigator monitors the participants and checks how effective this medication is going to be safe. FDA estimates 33% of medications go into phase III.

Phase-3

In phase III up to 3000 participants can involve. The goal of this phase is to evaluate how the new medication works in comparison to previous medication for the same situation. To move forward with the trial.

Investigators give a demonstration of the safety and effectiveness of the medication as the current treatments option. For demonstration, the investigator uses the randomization process. In the randomization process, they choose some participate to receive the medication and some others participants to receive existing medication and compare it.

The trials of this phase are usually double-blind and in double-blind, neither investigator nor participants know which medication is receiving participants. This helps in eliminating bias while evaluating results. Phase III clinical trials require before approving new medication.

FDA approves the medication if the investigator shows the new medication is safe and effective as existing medication.

Phase-4

In this phase thousand of participants involve and it undergoes after approval of the new medication from the FDA. This phase happens to get more information about the medication and its results as it can last for many years.

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References: www.cancer.org

www.healthline.com

Disclaimer: All the content of this article is for information purposes only.