What Are Clinical Trials… And Why Do They Matter?

by Jamie Harper
Illinois CancerCare

There are typically 100 or more clinical trials going on at any given time at Illinois CancerCare.

Hearing the word “cancer” can be frightening. But today, people are living longer and experiencing a better quality of life due to increasingly successful treatments resulting from clinical trials. In cancer research, clinical trials are focused on preventing, diagnosing and treating cancer, as well as managing symptoms of cancer or its treatment.

Although many people believe that participating in a clinical trial is a “last resort,” patients at various stages of their cancer journey may be able to participate. We’ll walk you through the most important things you need to know about clinical trials and the impact they can have on you—or someone you love.

Understanding Clinical Trials
Research for new treatments begins in a lab and with animal testing. This is considered bench research. Clinical trials involve human volunteers and are the final step in determining the safety and effectiveness of new treatments. This stage of research also evaluates if new treatments are better than existing options.

Each clinical trial is led by a principal investigator (usually a doctor) who creates a plan for the study. This plan, known as a protocol, must be approved by the Institutional Review Board. The IRB ensures all activities of the protocol are safe and any patient safety issues are resolved. The protocol outlines the purpose of the trial, what drugs or treatments will be used, testing that will be conducted, the number of people needed, eligibility criteria and what information will be collected.

Clinical trials typically have four phases with distinct purposes. Throughout the entire process, researchers are committed to each patient’s privacy and safety.

  • Phase I Trials: Usually only a small number of patients are enrolled in this phase, which evaluates how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often and what dose is safe.
  • Phase II Trials: A phase II trial continues to test the safety of the drug in participants and begins to evaluate how well it works. These studies usually focus on a specific type of cancer.
  • Phase III Trials: In this phase, the new drug, combination of drugs, or surgical procedure is compared to the current standard. Using a process called randomization, each participant will be assigned to the standard group or the new group. Phase III trials often enroll large numbers of people and may be conducted at many clinics and cancer centers nationwide.
  • Phase IV Trials: This phase is post-market for new indications of an already-approved drug.

When learning about clinical trials, patients often wonder if they’ll be given a placebo—a drug that looks like the medicine being tested but contains no active substances. While some clinical trials use placebos, they are rarely used in drug testing for cancer. Most often, clinical trials for cancer compare standard treatment plus a new treatment to a standard treatment plus a placebo. You will be informed if a placebo is used in the study for which you volunteer.

Choosing to Participate
As a patient at Illinois CancerCare, you may have an opportunity to be part of research using emerging drugs or state-of-the-art treatments. Participation is voluntary, and your safety is the focus throughout the study.

In order to achieve the best results, it’s important to have a pool of participants with similar medical situations. This improves the likelihood that results are due to the treatment itself and not some other factor. The protocol defines who may participate based on a variety of factors. This is known as eligibility criteria and may include:

  • A certain type or stage of cancer;
  • Previous treatments (or lack thereof);
  • Specific genetic changes in your tumor;
  • Age;
  • Gender (in some cases);
  • Medical history; and
  • Current health.

Most health insurance plans will cover the routine patient care costs of clinical trials. Your insurance will be reviewed, and any medical tests required to determine your eligibility for the study will be discussed. In addition, a clinical research professional will review the potential risks and benefits with you when discussing the study’s protocol.

Knowing the Benefits and Risks
Like everything else in life, there are benefits and risks to participating in a clinical trial. That’s why understanding the potential risks and benefits are an important part of your informed consent. Among the possible benefits:

  • You will have access to newer treatment that isn’t yet available to other patients.
  • The research team will monitor you closely, giving you additional peace of mind.
  • You may be given additional tests, which can provide valuable information.
  • If the study’s treatment is more effective than the current one, you may be among the first to experience the improved results.
  • In addition to benefitting you (or a loved one), the trial may help researchers learn things that can help other patients in the future.

Potential risks include:

  • The new treatment may not be better than the current treatment—and could be less effective.
  • You may experience new or different side effects than those that occur with standard treatment.
  • You may need to undergo additional tests and/or make more frequent visits to the doctor, which can be inconvenient and increase associated travel costs.
  • Health insurance may not cover all costs related to the study.

Taking the Next Step
Dedicated to improving the quality of life for patients throughout western and central Illinois, Illinois CancerCare physicians have a wide range of research interests that address cancer treatment, cancer prevention and symptom management. A part of this research has been coordinated through a federal program called the NCI Community Oncology Research Program (NCORP), which brings the benefits of clinical research to cancer patients in their hometown.

Illinois CancerCare was also recognized by the Quality Oncology Practice Initiative (QOPI) certification program for outpatient hematology-oncology practices that meet the highest national standards for quality cancer care. This further demonstrates an ability to provide patients with access to cutting-edge cancer research that leads to new treatments and better outcomes.

As one of the largest private oncology practices in the country, Illinois CancerCare has a 40-year history of conducting quality research and delivering innovative therapies. There are typically 100 or more clinical trials going on at any given time—a current list can be found at illinoiscancercare.com. You are encouraged to discuss your potential participation with your oncologist, or call 1-800-793-2262 for more information. iBi

Jamie Harper is director of research at Illinois CancerCare.

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