How Many Phases Of Clinical Trial Are There?
The aura surrounding these words,” Clinical trials,” is quite daunting, but they are an essential part of medical research and play a pivotal part in medicinal progress. The entire process involves human volunteers to develop new treatments that have the potential to improve our health. The good news is that the trial is not hasty; before it begins, there is a rigorous process that aims to ensure the safety of the treatment and its ability to work better than existing options. Let’s discuss each phase in detail.
During “Phase I clinical trials,” scientists work on the safety profile of the test on human subjects. However, you must note that the trial starts on humans only after being tested on laboratory animals. Usually, this phase is quite long, lasting several months to a year, with about 20 to 30 participants. This phase of a clinical trial is a critical step where researchers gather various types of data on the medicines’ dosage, intake timing, side effects, and their impact on the condition. Those who take part in this Phase are among the first ones to receive the groundbreaking treatment, and their contributions are invaluable.
Phase II clinical trials are a step further. Researchers at this point are looking into how safe the treatment is and assessing its effectiveness. This is done in relation to a particular type of condition, such as cancer. This phase often includes multiple age groups (participants) and may last for 2 years. One example is having 2 groups: one receiving the standard treatment, and the other a combination – standard along with the new treatment. On the other hand, there could be 3 groups as well, each getting a varying dose of the new treatment. The data collected during this phase offers valuable insights into how well the treatment works, which is a necessary step before moving to Phase III.
Phase III of the clinical trial is the true test of a treatment’s potential. This point is after the treatment shows promising results in Phase II. During this stage, it is made sure that the standard treatment is better, has fewer side effects, or both. These trials may last many years and often involve a multitude of participants representing diverse demographics. If Phase III of a trial represents that the treatment is effective, it is now time to make it available to the public. For this, regulatory bodies such as the Food and Drug Administration (FDA) have the responsibility to review the results and make sure that they abide by necessary standards.
The story does not end even after getting approval. Phase IV clinical trials monitor the long-term effects and benefits of the treatment. Doctors and researchers explore different dosages, various drug combinations, changes in administration, etc. These trials focus on the safety of treatments, ensuring that any new or severe side effects are immediately reported.