Clinical trials phases are an important part of any pharmaceutical development process. It’s important to know which phase of clinical trials you’re in before you make decisions about the next steps. Let’s break down the different phases of clinical trials and see how everything works together.
A clinical trial is a technique of testing new ways of preventing, diagnosing, or treating health conditions. The main objective of a clinical trial is to assess whether a particular technique is both effective and safe. According to ObvioHealth (ObvioHealth.com) several things can be assessed via clinical trials and they include:
- Medical devices
- Medical treatments
- Medications
- New applications for existing medications
Investigators typically perform preclinical research using animal models or human cell structures before they conduct a clinical trial. For instance, they could test whether a certain medication is lethal to a sample of human cells in the lab.
If the results from the preclinical research are positive, then they move forward to the clinical trial phase to evaluate its effectiveness in humans. These trials occur in four different phases where various questions are asked. Every trial phase is built on the previous phases’ results.
Keep reading to know more about what takes place during every phase. In this post, we will use an instance of a new medication that is undergoing the clinical trial phase.
Phases of a Clinical Trial
Phase 0 clinical trial phase – Determining whether a new medication treatment works and how it may work
Although phase 0 research is performed on human beings, this form of research is significantly different from the other clinical trial phases. The objective of phase 0 is to assist in speeding up and streamlining the process of drug approval. Phase 0 can also be used to determine whether a particular drug works the way it is expected to do. This can help to save money and effort that would have instead been used on the later phase trials.
In phase 0 research, small doses of the drug under study are administered to a few people, usually about 15. The role of this study could be either to see how the drug behaves when in the human body, the drug gets to the tumour, or how cancer cells in the body respond to the drug. The people participating in this study could require additional tests like scans, biopsies, and blood samples during the process.
However, phase 0 is not used widely and it isn’t a requirement during drug testing.
Phase 1 clinical trial phase – Is the medication treatment safe?
A phase 1 clinical trial phase is mainly the first stage that involves people. This phase is carried out to determine the highest dose of a particular treatment that can be safely administered without bringing about side effects. Although the drug has been tested in the laboratory using animal studies, the side effects of the drug on humans can be determined accurately. Therefore, this phase can assist in finding the best and safest way of administering a new treatment.
Phase 2 clinical trial phase – Does the drug work?
Once it has been established that a new drug is safe and effective during the phase 1 clinical trial, then a phase 2 clinical trial is carried out on participants who are suffering from the condition that the new drug is designed to treat. The dose that was administered and found safe during phase 1 is the same that is administered to the participants in this phase.
The investigators usually monitor the progress of the participants over several months to determine the effectiveness of the medication and obtain information regarding the potential side effects. Although this phase involves a greater number of people, it is not large enough to determine the overall safety of a particular medication.
Phase 3 clinical trial phase – Is the new medication better than what is available already/
The medication that has been proven to work in phase 1 and phase 2 have to be successful in yet another phase before they can be approved for use. Phase 3 trials are used to compare the effectiveness and safety of a new drug against the present standard treatment. In this phase, participants are picked at random because the investigators are not certain which medication is better yet.
Phase 4 clinical trial phase – What other information should we know?
The phase 4 clinical trial is carried out after a particular medication has been approved by the FDA. This phase involves thousands of participants and it can take numerous years. Investigators employ this phase to obtain more information regarding the safety and effectiveness of the new medication in the long-term, and other benefits that can be experienced.