As the science of treating cancer has advanced, researchers have developed better, more effective treatments, which means patients now have more options.

Choosing a treatment path and whether or not to participate in a clinical trial can be a very difficult decision. This is a question only you, those close to you, and health professionals familiar with your situation can consider and answer together.

Holding a patient's hand

What Are Clinical Trials?

Clinical trials are research studies conducted with human patients. The trials are designed to discover improvements in prevention, diagnosis, or treatment options for a disease, such as sarcoma. They are part of a meticulous research process in which patients receive a new treatment (a new drug, new approach to surgery or radiation therapy, or new combination of treatments) that already has been researched in successful laboratory and or animal studies. Some clinical trials may even study drugs or procedures that have already been approved by the US Food & Drug Administration (FDA) for a different purpose. Most of the widely accepted medicines and treatments used by today’s medical experts are based on the results of previous clinical trials.

Why Participate?

It is often thought that clinical trials are a last resort, but they may in fact be a good way to begin your treatment and receive excellent care from the very start. Of course, certain trials may not be right for all patients, based on eligibility criteria (requirements that patients must meet before they can participate – such as age, gender, subtype and stage of cancer, previous treatments, and other medical conditions) or availability. But if you find a trial that is right for you, you will have access to cutting-edge medicine and health experts, and constant monitoring of your progress.

Additionally, your participation in clinical trials may contribute to the search for ways to prevent, detect, or treat the disease. As a direct result of patients’ participation in past clinical trials, people with cancer are today living longer. All patients in clinical trials are volunteers, so they can stop their participation at any time.

However, there is no guarantee that a new treatment being tested will yield good results. New treatments may also have unknown risks, so before you make this decision, you should think about it carefully, considering all other possible treatment choices, and communicate with your doctor to help decide if this is truly the best option.

Informed Consent Process

If your doctor offers you the option to participate in a clinical trial, you will first take part in a process called informed consent. In this process you will learn about a specific clinical trial so that you may decide whether you want to participate.

The researcher or nurse from the clinical trial team will review the informed-consent form in detail with you. This form explains the purpose of a specific clinical trial and its procedures, risks, and potential benefits.

An informed-consent form should include: the reason for the trial, what researchers wish to learn from the results of this trial, who is eligible to take part in the trial, what is known about the type of treatment being studied, the possible risks and benefits, other treatments that may be options, the trial’s design (randomized, single blind, or double blind), types of tests, the number of doctors visits required, who is responsible for the costs, a statement about conflicts of interest, patient privacy, and patient rights. Should you decide to participate, you, the trial’s primary investigator, and a witness must sign and date the informed-consent form.

You will be encouraged to ask questions about terms or ideas that are confusing. A family member or friend may help by attending your appointments with you to listen to the doctor’s explanations, ask additional questions, and record the answers. You can also record the conversation and review the information afterward.

The informed-consent process also continues throughout the study. Patients will be told of any new discoveries regarding the progress of the trial, such as new risks. At that time, you may be asked to sign a new consent form to stay in the study.

Even after signing the informed-consent form, a patient can choose to withdraw from a trial at anytime, for any reason.

Learn more about active SARC Clinical Trials.

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