Clinical studies in phase II: Is the treatment effective?
If a new medication is determined to be safe in phase I clinical trials, it is next tested in phase II clinical trial to evaluate if it works in specific forms of cancer. The benefit sought by doctors is determined by the treatment’s purpose. It is possible that cancer will shrink or disappear.
Or it could suggest that cancer does not grow for an extended length of time or that it takes longer for the disease to return. According to certain studies, the benefit could be enhanced quality of life. Many clinical studies are conducted to determine whether patients who get the new medication survive longer than the general population.
Phase II clinical trial highlights
• In a phase II study, 25 to 100 individuals with the same form of cancer receive the new treatment.
• In phase II clinical trials, everyone receives the same dose and procedure that were shown to be the safest and most successful in phase I investigations. However, in certain phase II research, patients are assigned to different therapy groups at random. These groups may receive different doses or treatments in order to determine which gives the optimal balance of safety and response.
• In phase II trials, no placebos (inactive medicines) are employed.
• Phase II research can be conducted at major cancer centers, community hospitals, or even doctors’ offices.
Because phase II trials enroll a larger number of patients, less common adverse effects may be observed. Phase III clinical trials are initiated if enough patients benefit from the medication and the side effects are not too severe.
Is it superior to what’s already available in Phase III clinical trials?
Treatments that have been shown to be effective in phase II clinical trials must also be successful in a third phase before they can be licensed for general use. Phase III clinical studies assess the novel treatment’s safety and effectiveness compared to that of the current standard treatment.
Because doctors do not yet know which treatment is superior, study participants are frequently assigned at random (referred to as randomized) to either the traditional or innovative treatment.
When feasible, neither the doctor nor the patient is aware of which of the treatments is being administered. This is referred to as a double-blind study. Randomization and blinding are covered in further depth later.