A new therapy passes through several stages. Each stage serves a distinct purpose:
Phase I Trials
Phase I trials determine the most effective approach to provide a novel medicine while also determining its safety. Doctors monitor the novel cancer treatment for any signs of response. Phase II trials determine if a particular cancer type reacts to the novel therapy. Phase III trials evaluate whether a novel treatment is superior to accepted practices. Phase IV trials provide greater details on long-term advantages and disadvantages. Typically, when you enroll in a clinical trial, you will only be a part of that specific investigative phase. Treatments, not patients, go through the stages.
Phase I trials check the safety of a novel treatment on humans. Doctors determine the most effective method of treatment. A Phase I trial’s objectives are to assess the safety of a novel treatment, choose the most effective delivery method for the new therapy, such as a vein or the mouth, and check for indications that the new treatment is affecting cancer.
In phase I trials, 15 to 50 patients are typically separated into smaller groups. Cohorts are the name for these groups. The new medication is administered to the first cohort. Doctors may take blood or urine samples to assess the patient’s medication levels.
A second cohort is given a more significant dose of the same medication if the initial cohort does not have any severe side effects. Each successive cohort raises the dose until the medical professionals determine the optimal dose. Every patient is tested to evaluate how they react to the medication after each dose increase. The treatment will proceed to be examined in a Phase II trial if the medical professionals determine it is safe.
Phase II Trials
Phase II trials check the efficacy of a novel treatment for a single cancer type. In a Phase II experiment, less than 100 patients typically participate. Doctors regularly monitor patients’ adverse effects even though the primary objective is determining whether the treatment is effective. Doctors might continue researching the novel therapy in a Phase III trial if it is successful.
Phase III Trials
Phase III Trials check to see if a novel treatment is more effective than the norm. Hundreds to thousands of people may participate in phase III trials across the nation or the globe. Each participant in Phase III clinical study has an opportunity to be in one of the following categories: Control group: the individuals who receive routine care. Study group: the individuals who receive the experimental new medication. Doctors think the new treatment is as good as the current one and may even be better, but they are still determining if it is.
The FDA examines the clinical trial results following the Phase III study to ensure that the medication is suitable for human use and is both safe and effective. For the medicine to be accessible to all patients, the FDA must determine whether to approve it.
Phase III trials are the subject of numerous commonly asked questions. These consist of the following:
How are the groupings of patients formed?
Which patients are in the control group and which patients are in the study group is decided by a computer. Each group has a probability of including a patient. The doctor makes a choice, not the patient. It is random and solely the result of chance. By doing this, bias in the clinical trial is reduced. (Bias occurs when human decisions impact a study’s findings.)
Does my doctor know which category I fall under?
In single-blind trials, only the physician is aware of the patient’s assignment to the control or study group. In studies employing double blinding, neither the subjects nor the researchers are aware of which group they belong to.
Was a placebo given to me?
A placebo is a substance that appears to be a medication but is not. If a placebo is employed, it is administered along with the best-recommended course of treatment. This enables medical professionals to contrast conventional care with standard care combined with new medicine. The placebo may be administered alone if standard treatment is unavailable, but this is uncommon in cancer trials.
Phase IV Trials
Phase IV trials IV-Phase Trials find out more details regarding long-term adverse effects. Doctors examine therapies that the FDA has already approved in Phase IV trials. Phase IV trials are designed to continue researching a new treatment’s side effects.
