Consider a Cancer Clinical Trial

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 may be a very difficult decision to make. This is a question only you, those close to you, and health professionals familiar with your situation can consider and answer together.

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Clinical trials are research studies conducted with human patients, used to discover improvements in prevention, diagnosis or treatment options for a disease, such as sarcoma. They are part of a meticulous research process involving patients receiving 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 (and some may even study drugs or procedures that have already been approved by the FDA in a different light). Most of the widely accepted medicines and treatments being used by today’s medical experts are based on the results of previous clinical trials.

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 great 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 and thus can stop their participation in the trial 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. If you are offered a clinical trial as a treatment option, you will go through a process called informed consent, in which you will learn about the specific trial, including information about its logistics and design.

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, procedures, risks, and 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 trials design (randomized, single 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 PI, 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 physician's explanations and ask additional questions and also record the answers. You can also bring along tape recorders to 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.

Again, even after signing, a patient can choose to withdraw from a trial at anytime, for any reason.