Clinical Trials

Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for people. Clinical trials also may show which strategies work best for certain illnesses or groups of people. You may consider participating in a sarcoma clinical trial for the following reasons:

  1. Your current treatment may not be working as well as expected.
  2. A clinical trial may significantly improve your quality of life. Discuss your expectations about side effects with your doctor.
  3. You may have a rare type of sarcoma that hasn’t been studied as much as other types.
  4. Simply participating helps refine and improve the way millions of people with all types and stages of cancer are treated. You’ll not only help researchers identify treatments that work, you’ll help them eliminate treatments that don’t.

Although all the advances in cancer treatment that are saving lives today came from clinical trials, patient participation tends to be low. One reason may be that people don’t know enough about trials. To ensure you understand what to expect, do your research. Explore available trials by talking with your doctor and searching online (see Additional Resources at bottom of page). Consult with your doctor and the medical team that will be conducting the clinical trial. Talk with people who have participated in clinical trials, but remember that not everyone has the same response to treatments. You cannot expect an identical experience in terms of response to treatment, side effects, etc.

Cost concerns regarding insurance coverage are another reason people decline to volunteer; however, resources, such as the Affordable Care Act, are available. The Affordable Care Act requires all private insurance companies to cover routine patient-care costs from in-network providers associated with an approved clinical trial. Patient-care costs include those related to doctor visits, hospital stays and some testing procedures that are part of standard care in a clinical trial. An approved trial is defined as a trial in any phase that is aimed at preventing, detecting or treating cancer. Research costs, which are directly related to the clinical trial and include drugs and procedures, are typically covered by the trial sponsor. Always explore your plan benefits with your insurance company before volunteering.

People often find they have more positive treatment experiences when they are educated about and actively involved in decisions about their care. Be your own best advocate, and learn more about clinical trials so you can make an educated decision.


Myth vs. Fact

MYTH: Clinical trials are only for people who have no other options for treatment (a “last resort”).
FACT: Clinical trials of cancer treatment may be available for individuals with cancer of all types and stages.
MYTH: Once you begin a clinical trial, you are locked in.
FACT: Participation is always voluntary, even after the trial begins. You can decide to leave the trial at any time.
MYTH: Clinical trials are not safe.
FACT: Clinical trials have many built-in safeguards to ensure that participants’ rights and safety are protected. These safeguards include an institutional review board, a data and safety monitoring board, and an ongoing informed consent process.
MYTH: Clinical trials only take place at large hospitals or cancer centers.
FACT: Many clinical trials take place at local hospitals, cancer centers and doctors’ offices in all parts of the country (both rural and urban areas).



Words to Know

As you learn more about clinical trials it helps to know the terminology.

Blinded: A study in which you do not know which treatment group you are in. In a single-blind trial, you don’t know what treatment you’re receiving. In a double-blind trial, neither you nor the researchers know who is receiving the experimental drug.

Control group: The participants who are assigned to receive the standard treatment that is being compared with one or more experimental treatments.

Copay: The fixed amount you must pay for specific types of medical care.

Eligibility criteria: The guidelines defining who can participate (based on age, sex, health status, type and stage of cancer).

Health insurance exchange/health insurance marketplace: A central hub for those seeking health insurance to review plan options, see premium rates for each and enroll in a plan.

Informed consent: A document that contains all the important information about the study, including possible risks and benefits and alternatives to the research being conducted. The document stresses that enrolling and remaining in the study are completely voluntary and that you may leave the study at any time. Generally, you must sign an informed consent document to enroll in a clinical study.

Placebo: An inactive drug given in a control group to simulate treatment with an active agent. Placebos generally are not used instead of treatment in cancer clinical trials. They are given along with the standard treatment.

Premium insurance tax credits: Also called “insurance subsidies,” these are tax credits from the federal government that reduce the cost of health insurance premiums given to individuals who qualify. Credits are available to use immediately to offset insurance costs.

Protocol: The rules that every clinic, hospital, university or cancer center must follow in a clinical trial. The protocol outlines the eligibility criteria, tests to be used and procedures to be performed, describes the medications and their doses, and establishes the length of the study.

Standard treatment, standard therapy or standard of care: The drug or treatment that experts agree is the most widely used for a particular type and stage of cancer.

Additional Resources


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