Cancer Care: Your Guide to Clinical Trials
BY MD ANDERSON CANCER CENTER
After receiving a cancer diagnosis, you may be faced with many questions about how to pursue the best course of treatment. One of those questions might be whether to participate in a clinical trial, which are for patients at all stages of disease.
MD Anderson Cancer Center is a global leader in cancer care and home to the most distinguished and extensive cancer clinical trials program in the world. In 2017, MD Anderson had more than 10,800 participants enrolled in over 1,250 clinical trials, exploring groundbreaking treatments.
Here’s what you need to know about clinical trials – and why they’re at the core of our mission to end cancer.
What Is a Clinical Trial?
Clinical trials are research studies in which patients may volunteer to take part. “By enrolling in a clinical trial, you help us advance cancer care by discovering more successful treatments that may extend or save your life,” said Patrick Hwu, M.D., division head of Cancer Medicine at MD Anderson.
Clinical trials are safe and controlled research studies designed to help doctors find better ways to treat, diagnose and prevent cancer. While some trials study new medicines or methods of dispensing treatment, others focus on dosage or whether a drug can successfully treat a different type of cancer.
Most trials compare the existing standard of care to potentially better therapies, so participating patients at all stages of disease gain access to pioneering treatments and might increase their chances of successful treatment.
What Are the Phases of a Clinical Trial?
A new treatment goes through several phases, each with its own purpose:
- Phase I: Tests whether a new treatment is safe, looks for the best way to give the treatment, and watches for signs that cancer responds to the treatment.
- Phase II: Focuses on how a specific type of cancer responds to the new treatment.
- Phase III: Tests whether a new treatment is better than the standard of care. After this phase, the Food and Drug Administration (FDA) reviews the new drug or procedure.
- Phase IV: After FDA approval, Phase IV determines the long-term benefits and side effects of the new treatment.
Although a treatment moves through the phases, a patient does not.
Are Clinical Trials Safe?
Clinical trials are developed by medical experts, and patient safety is the highest priority. Trials go through several rounds of approval. “Before enrolling patients, a proposed clinical trial receives its final approval from the Institutional Review Board (IRB), a committee made up of physicians, nurses, researchers, patients and lawyers,” said Dr. Hwu. The FDA audits the IRB’s files to make sure patients are protected.
What Are the Benefits and Risks?
Benefits
- You receive cutting-edge treatment.
- You have access to therapies not yet available to the public.
- The treatment may extend or save your life.
- You help advance cancer care for future patients by being part of testing newly discovered treatments.
- You work with a research team that closely monitors your care and progress, including a physician who leads the trial and ensures that your care team follows a specific treatment plan, and a research nurse who guides you through the trial and collects data.
Possible risks
- You may experience side effects that the doctor did not expect or that are worse than those of standard care.
- The new treatment might not be better than or even as effective as standard treatment.
- The new treatment might not work for you even if it works for other patients.
Should I Participate in a Clinical Trial?
If your care team recommends that you participate in a clinical trial, it is because they have determined that this is the best treatment option for you.
The decision is personal and often based on a host of factors, including your overall health, your specific type of cancer and stage, and the availability of a trial. It’s important to try to get treatment at a research-based cancer center like MD Anderson that offers a wide range of clinical trials. Through our world-renowned clinical trials program, we are transforming the way doctors understand and treat both common and rare cancers.
