Understanding the Phases of a Clinical Trial

Do you fully understand the phases of a clinical trial?

Since the onslaught of the pandemic, the term clinical trials has constantly been in the news as clinical groups race to develop new vaccines. You might have also heard experts talk about vaccines undergoing phase 1 of a clinical trial. With all the buzz on clinical trials, how deep is your knowledge on the subject?

For instance, did you know that phase 0 of a clinical trial isn’t widely used? It may also surprise you to know that phase 4 takes place after the approval of the new drug or treatment.

As one of the essential subjects to date, it’s vital to research clinical trials. An informed customer is a wise consumer, after all. So read on for a quick rundown on the phases of a clinical trial today!

Phases of a Clinical Trial: Phase 0

The primary purpose of phase 0 is to help researchers confirm if the drugs are doing what they’re supposed to do. This includes whether the drugs have reached the target area.

Phase 0 studies involve a small number of participants, often 10 to 20 people. It also only uses small doses of the drug subjected to testing for a short time. Unlike other phases of a clinical trial, participants almost have no direct benefit to gain from phase 0 trials.

Information found here accelerates later results as well as the treatment’s approval. This, in turn, saves researchers time and money spent on the Clinical Trials Supply.

Phase 0 trials, however, aren’t required when testing a new drug. This is why they aren’t widely used in the clinical research community, especially because there are drugs that won’t benefit from phase 0 studies.

Phases of a Clinical Trial: Phase 1

A Phase I clinical trial, like phase 0, also looks into the interaction between the drug and the body. However, the main concern of phase 1 clinical trials is to establish how safe the drug will be once used by humans.

Although the newly developed drugs have undergone tests in laboratory and animal studies, the exact side effects on humans are still murky. Hence, Phase 1 studies are important in finding out the side effects of a new drug.

Phase 1 studies are also key in discovering the best way to use the drug. Through phase 1, researchers find out the highest dose that can be safely given to humans.

Phase 1 studies are escalation studies in which drug dosage escalates. Here, the first few participants receive very small doses of the new drug. The research team will watch the participants and look for any signs of severe side effects.

If the first participants are only showing minor side effects, the next participants will get a higher dose. This process will continue until researchers can find out what dosage is acceptable given the side effects.

Phase I trials often involve a small number of people, 20 to 50 people at most. Among the phases of a clinical trial, phase 1 carries the most risk.

Phase 2 of a Clinical Trial

After establishing that the new drug being developed is safe, phase 2 trials take place. Phase 2 trials involve up to 100 or so people. Thus, Phase 2 trials allow researchers to test the new drug on a larger group of people.

With a larger group of participants, researchers may be able to see less-common side effects. Phase 2 trials allow researchers, thus, to find out more about the side effects of the new drug. Moreover, phase 2 trials help researchers look into how well the new drug works.

Depending on the goal of the new drug, the benefits that the researchers will look for in Phase 2 will vary. Many drugs, for instance, aim to lengthen the lives of cancer patients. With this kind of goal, the researchers will test the drug to see if it’s effective in helping patients live longer.

25 to 100 participants with the same type of cancer will receive the new drug in phase 2. They’re treated using the method that researchers found to be the safest and most effective in phase 1.

The new drug tested in phase 2 will only pass and move through phase 3 when they meet two requirements. One requirement is that the patients benefit from the use of the said drug. The second requirement also requires participants not to show adverse side effects.

Phase 3 of a Clinical Trial: Is the New Drug Better?

The purpose of a Phase 3 trial is to find out if the new drug or treatment is better than the existing one. Hence, researchers compare the new treatment against the current standard treatment in terms of safety and effectiveness.

This phase also aims to determine how the new drug or treatment will affect the quality of life of patients. Often, Phase 3 trials involve thousands of people from different hospitals or even different countries.

Phase 3 studies are also almost always done at random. The participants get randomly assigned to treatment groups. These groups get different treatment doses or get the treatment in different ways.

Phase 4

A drug may get FDA or MHRA approval because it’s been shown to help reduce the risk of the recurrence of cancer. However, do the results mean that those who used the new drug live longer than those who didn’t? Does the drug have no side effects even after long-term use?

Even after clinical tests, there are still a lot of unknown effects and implications of a new drug. This is why, even after approval, the new drugs are thoroughly monitored over a long period. Only then will answers to additional questions about the new treatment will appear.

Hence, Phase 4 of a clinical trial focuses on the safety of the new drug or treatment over time. Further, among the phases of a clinical trial, phase 4 trials are the safest.

Deepen Your Knowledge of Medicine Today!

To sum it up, new drugs or treatments must go through the different phases of a clinical trial. It helps researchers determine whether the new drug or treatment is safe and effective as theorized.

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