Clinical trials are the last step in a long process that begins with research in a lab and ends with new treatment options for children with cancer. In short, treatments used today are the result of past clinical trials. Unlike cancer in adults, when a child is diagnosed with cancer, they are almost always enrolled in a clinical trial. In fact, more than 60% of children undergoing treatment for cancer are enrolled in a clinical trial. This makes clinical trials essential to developing new treatments for children in need today.
There are three phases to clinical trials, each of which plays a different role in ensuring that treatments are safe and effective for children with cancer. Phase I trials are the first stage of testing a drug in humans and are used to find a safe dose, they usually involve 15 – 30 people and their goal is to measure how the treatment affects the human body. Phase II trials take place after Phase I and determine if the new treatment is effective in treating the cancer and measures the side effects of the treatment on the body. Involving less than 100 people, this phase is important in determining if the treatment will be effective against the cancer. Phase III trials can involve 100 to several thousand patients and compare the new treatment being studied with existing treatments, measure effectiveness. When a Phase III trial is complete, if the data show the treatment to be effective, it can become a standard of care for patients with cancer. Sometimes, Standards of Care are studied in what is called a Phase IV trial. Phase IV studies some aspect of the Standard of Care, for example, long-term side effects of the treatment.
In children’s cancer, participation in a clinical trial usually spans 2-3 years and in the later phases, does not involve placebo medication. This type of research offers widespread impact for families because their child’s participation often promises the best chance for survival. At CureSearch, we believe that clinical trials offer children a better chance for survival by delivering treatments that show the greatest potential for a cure.