Understanding Clinical Trials

Before new cancer treatments can be made widely available to the general public, they must first be proven safe and effective. Clinical trials make this possible.

Clinical trials are research studies that involve people. Through clinical research studies, doctors prove new treatments to be effective and find new ways to improve upon current treatments as well as the quality of life for people with cancer. If you or a loved one need treatment for cancer, clinical trials could be an option to consider.

Affiliated Oncologists is an established research leader in communities across the greater Chicago area and offers clinical trials through Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials. SCRI has contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today.

Our research program, SCRI at Affiliated Oncologists, provides access to the latest clinical trial options to people facing cancer and is part of an expansive research network with the goals of advancing therapies for patients and transforming cancer care within the community, where the majority of people seek cancer treatment. At any given time, Affiliated Oncologists offers clinical treatment options for various disease types, including:

Why Cancer Research Trials are Important

Clinical trials are a key research tool for advancing medical knowledge and patient care. Without cancer research and clinical trial participants, most of the cancer treatments used today as a standard treatment would not be available.

There are four different types of clinical trials, which include:

• Treatment trials, which test new drugs, medical procedures, or combinations of treatments

• Prevention trials, which look at cancer risk and ways to reduce that risk by either doing something (called action studies) like making lifestyle changes, or taking something (called agent studies) such as medicines, vitamins, or minerals

• Screening trials, which test new ways to find a disease early, when it may be more easily treated

• Quality of life trials, which explore ways to improve comfort and quality of life for cancer patients

These trials are structured into four phases:

• Phase I: Researchers test a study drug in a small group of people (about 15-30) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

• Phase II: The study drug is tested in a larger group of people (less than 100) to measure its effectiveness and further evaluate its safety.

• Phase III: The study drug is tested in large groups of people (from 100 to several thousand) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments, and collect information that will allow the study drug to be used safely. These studies are often done in many places across the country (or even around the world) at the same time.

• Phase IV: The drug is tested after it has been approved by the FDA and marketed to collect information about its effect in various populations and about any side effects associated with long-term use. Researchers may also test for new indications of a new drug or test the combination of approved drugs to see what kind of results there may be. These studies may involve thousands of people.

How Cancer Clinical Trials Can Benefit You

By participating in a clinical trial, you can access new research treatments before they are widely available. Additionally, your participation also may help others by contributing to medical research.

Keep in mind that cancer clinical trial participation is strictly voluntary. Those considering participation must first learn the key facts such as the purpose, risks, and benefits of a clinical trial— a process called informed consent. If you choose not to participate, you may withdraw your decision at any time and for any reason.

For most patients, clinical trials are not the first course of treatment that will be tried. But, as you progress through your cancer treatment process, you may qualify for a study that could benefit you and other cancer patients in the future.

For more information on clinical trials, visit ClinicalTrials.Gov, or the National Cancer Institute. You may also contact us directly or learn more about the clinical trials available at Affiliated Oncologists.