Offering our patients access to leading-edge treatment through clinical trials is a vital part of our mission. Through Rocky Mountain Cancer Centers’ relationship with US Oncology Research, our patients have access to different clinical trials representing all major cancer types and all phases. US Oncology Research has played a role in nearly 70 FDA-approved cancer therapies — approximately one-third of all cancer therapies approved by the FDA to date.
Dr. Allen Cohn is the Medical Director of Research for RMCC. In 2017, RMCC enrolled more than 1,000 patients in clinical trials. Currently, we are enrolling patients in nearly 60 active clinical trials.
The American Association for Cancer Research (AACR) partners with advocacy groups, cancer centers, and research institutions to raise awareness of the high-quality, innovative cancer research happening across the country and the lifesaving impact that research can have.
And that impact is huge. The AACR estimates that 15.5 million people in the United States are cancer survivors, thanks to the advancements made through research .
Despite the important role they play in advancing cancer treatment, clinical trials may seem mysterious to many patients who don’t fully understand how they work. Here, we offer a primer on the four phases of a clinical trial.
Phase I Cancer Clinical Trials
Phase I cancer clinical trials often mark the first time a new therapy is given to people. The purpose of a Phase I study is to test the safety, side effects, best dose, and timing of a new treatment. Typically, only a small number of people are enrolled in a phase I trial
A phase I trial may also try to determine the best way to give patients a new treatment. For example, is it most effective by mouth, infusion into a vein, or injection. The phase I trial also evaluates how the treatment affects the body.
In a phase I trial, the first few people enrolled in the study often receive a low dose of the treatment, and are monitored closely. The dose usually is increased a little at a time in order to find the highest dose that does not cause harmful side effects.
Phase II Clinical Trials
In a phase II trial, which often involves about 100 to 200 patients who have the same type of cancer, researchers evaluate whether a new treatment has an effect on the disease, the side effects, and the safety of the treatment.
Phase II clinical trials provide more information about the safety of the new treatment and how it affects the body. While some phase II trials randomly assign participants to different treatment groups, all patients receive treatment, the doses are usually set and no longer increased or adjusted at this phase.
Phase II trials may last a couple of years, and often participants are divided into two groups:
• People taking the already approved treatment (also called the standard treatment)
• People taking regular treatment along with a new treatment that is being studied.
Phase III Clinical Trials
In a phase III study, researchers continue evaluating the safety of a new therapy, as well as how effective that treatment is compared with an existing treatment.
For example, phase III clinical trials may compare which group of patients has better treatment response or fewer side effects. In most cases, treatments move into phase III trials only after they meet the goals of phase I and II trials.
Phase III clinical trials may include hundreds of people, and often are carried out in numerous locations across the country. Typically, they last longer than earlier phases of clinical trials.
Following a phase III trial, the developers of a new treatment may ask the FDA to approve that treatment for widespread use.
Phase IV Clinical Trials
Phase IV clinical trials continue to evaluate the safety and effectiveness of drugs that already have been approved by the FDA. These studies may also assess other aspects of the new treatment, such as how it affects quality of life, or whether it is cost effective compared with other drugs.