A clinical trial is significant but also a very crucial part of a research. Before beginning a clinical trial, doctors must prove that there is a chance by which the new treatment or a method will work better than any presently available one. Research continues until it gets proved. Doctors do several clinical trials to test many things, which include:
A novel treatment or a medical process
An innovative mix of the existing treatments
A novel surgery
Novel medical device
Changes in lifestyle, like eating habits, exercise, or counselling
They might test the same on laboratory animals before testing it on a human. This is to ensure that it is safe to test on men.
Phases of clinical trials:
Each trial follows certain steps, known as phases. The steps are created to keep the life of people safe in the clinical trial. Sometimes, phases are done together, paralleled. To ensure that all the steps are done to help protect patients and give accurate results about what the trial is testing.
A volunteer can join any phase of a clinical trial if the option is appropriate for you and the type and stage of cancer you have.
Phase I clinical trials
The physicians do this to learn if a new drug, or a treatment, or a combination of treatments is safe for people.
In a phase I trial, doctors collect information on the following:
Dose or treatment
The count of taking the medicine or treatment
Any side effects or hazards
How a person responds to the treatment.
If you volunteer for a phase I clinical trial, you could be one of the first people to get the promising new drug or treatment.
The duration of Phase I clinical trials could be several months to a year. Often it constitutes 10 to 30 volunteers. The treatment might help the patient, and the trial information could help other patients in future.
Phase II clinical trials
This tells the doctors more about how safe the treatment or medicine is and how well it works. In phase II trials, doctors also test whether a new treatment really works for specific cancer. They might measure a tumour or take blood samples to assess if the treatment is acting. They can also ask you to maintain a log of your daily activities and symptoms.
A Phase II trial lasts for about 2 years. Sometimes, volunteers opt for different treatments. For instance, a phase II clinical trial can have 2 groups:
Group 1 – People who take the regular treatment (standard treatment)
Group 2 – People who take the regular treatment and a new treatment on which doctors are that studying in the trial
In another instance, a phase II trial can have 3 groups. Volunteers in each group receive a different dose of the new treatment on which study is being carried out.
If a phase II trial shows the treatment is likely to work and is as safe as a regular treatment, doctors can go for a 3rd trial phase.
Phase III clinical trials
This tests a new treatment that has worked well on patients in the 2nd trial phase. Doctors compare the treatment with the standard one. Standard treatment is yet the best-known treatment. The research team must find out if the novel treatment is better. Hence they need to assign people to various groups as a part of the trial.
This means to assign people in a clinical trial into various groups. Doctors do this with the help of computer programs. This is important when doctors have to compare 2 or more treatments.
Phase III clinical trials continue for many years. They usually have several thousand volunteers. The volunteers must include men, women, and people of every ages, race and ethnic groups. This helps doctors with insight how a treatment works for several different people.
If a phase III trial shows that the treatment works well for specific cancer, doctors start to use it with people outside the trial. When it is learned that a new medicine is safe and effective, then is needed approval from the regulatory bodies. In the US, it is the Food and Drug Administration or FDA. The FDA looks over the results of clinical trials. If the information meets their standards, the treatment gets approval.
How is a clinical trial “phase” different from cancer “stage”?
The cancer stages are different from clinical trial phases, even though both uses same numbers of 0, 1, 2, 3, and 4. A clinical trial phase not necessarily meets the stage of cancer. You can be any stage of cancer and be in any phase of a trial. The “phase” of a clinical trial is to describe the purpose of the clinical trial and how many people taking part in it. The “stage” of a person’s cancer tells the following:
How much cancer has spread?
What type of cancerous cells is affected? Some types of cells indicate the cancer is more aggressive or can get worse, and some do not.
Does the patient need to be in every phase of a clinical trial?
Well, the answer is No. You can be part of any phase of a clinical trial. For instance, you might join a phase II clinical trial of a specific treatment even if you didn’t take part in phase I of the trial.
With this, we conclude.
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