Clinical trials for cancer are research studies that compare the most effective known treatment for a specific type or stage of cancer with a new approach. This can be a new drug, or combination of drugs or a different way of using established therapies. There are trials that involve new approaches to surgery and radiation therapy. There are clinical trials for every type of cancer. While many trials focus on late stage disease, there are also trials to prevent cancer, improve early diagnosis, stop the cancer from coming back, reduce side effects or improve quality of life.
Cancer Clinical Trials:- Phases
Phase I: After the drug is approved for human studies, it is tested in a small trial to determine the optimal safe dose. Phase I studies often involve patients with different kinds of cancer, or more recently, a single genetic change.
Phase II: If a drug can be given safely to people on the Phase I trial, it is tested in a Phase II study. These are larger studies, usually for one or more specific types and stages of cancer. The goal of Phase II studies is to both determine the optimal dosing and provide an early assessment of whether the drug works.
Phase III: These trials take place after a drug has shown good results in earlier studies. They are large studies, often involving hundreds, or even thousands of patients, in multiple centers in the United States and/or abroad. Patients on Phase III trials have specific types and stages of cancer. Many Phase III trials are randomized—meaning that patients are randomly assigned to receive either the new treatment or the established standard of care. These trials are designed to provide definitive evidence to support FDA approval of the drug or agent for use in the public.
Phase IV: These trials take place after a drug is approved and are often called post-marketing trials. The goal is to make sure that no safety or other concerns come up after a drug is approved that may not have been seen in the pre-approval trials. It is important to follow patients for a number of years to determine if there are any long-term side effects or other issues that affect the way the treatment is used.