Understanding The Phases of Clinical Trial In Cancer
New cancer treatments go through various phases before they’re released to the public. This ensures that new treatments are more effective than existing therapies and that their benefits outweigh the risks. Here are the four phases of clinical trials used to test cancer treatments.
Phase I clinical trials in cancer research are used to determine if a new drug or treatment is safe for people. In this phase, the highest dose of the new treatment that can be given safely without causing severe side effects is decided. A few people will be given a small dose of the treatment and monitored for side effects. If there are only minor effects, the next few participants will receive a slightly higher dose. This process is continued until an effective yet safe level is found.
Although phase I trials have the highest potential risk, they can also help find new treatments. Volunteers are often those who have exhausted all of their other treatment options.
The main goal of phase II trials is to determine if the treatment is effective and how it impacts the body. Using the safest and most effective dose previously determined in Phase I, volunteers with the same type of cancer receive the treatment. Doctors may then measure tumor sizes, take blood samples, or check how well volunteers can carry out certain activities to determine how well the treatment works and its effects on people.
Although most phase II trials receive the same dose, some volunteers may be randomly assigned to receive different doses to learn which method strikes a good balance between effectiveness and safety.
Phase III trials are intended to determine whether the treatment being tested is better than what’s already available. A double-blind study is conducted. Volunteers are randomly assigned to either a control or study group, and neither the volunteer nor the doctor knows which group the volunteer will be given to. The control group receives the standard treatment, while the study group receives the treatment that’s currently being tested. Phase III trials can include hundreds of thousands of patients worldwide, and they typically last longer than phase I and II trials.
Suppose a phase III trial shows that treatment is safer and more effective than the current treatment. In that case, a new drug application is submitted to the Food and Drug Administration, which decides whether to approve the new treatment based on the results from clinical trials. If the drug is approved, it will become available to all patients. However, if the FDA believes that more evidence is needed to show that the treatment is safer & more effective than the current treatment, they won’t approve the drug and may order more studies.
Although doctors can prescribe patients a new treatment after being approved by the FDA, the FDA often requires that the treatment be continually monitored for potential side effects. They may study how the treatment works in children rather than adults or how it affects people when they take it at different times.
Phase IV clinical trials are the safest, as the treatment has already been thoroughly studied. These trials ensure that the treatment is safe long-term, and it may also look at other factors, such as cost-effectiveness or quality of life.
If you’re interested in a clinical trial for new cancer treatment, you must understand what each stage entails. You can join any clinical trial phase that you’re qualified to enter, so using this guide can help you define which one you wish to take part in.