Clinical Trials

Clinical trials are research studies that evaluate the safety and effectiveness of a medical strategy, treatment or device. They are also how the medical community determines a “standard of care,” the treatment that works best for certain illnesses or groups of people. In fact, many advances in cancer treatment that are helping save lives today are all products of research, and much of that research is done through clinical trials.

Depending on your diagnosis and other factors, a clinical trial may be a treatment option for you to consider. Although you may not know much about clinical trials yet, this information, along with input from your doctor, will help you understand more about the three types of clinical trials and what they may mean for you.

  1. Treatment Trials evaluate whether a new type of treatment (drug, surgery, radiation therapy) or a combination of treatments is better than the currently approved treatments being used.
  2. Quality-of-Life Trials study ways to improve the quality of life for people being treated for cancer and cancer survivors who experience cancer-related and treatment-related symptoms. This type of trial may evaluate the effects of such things as nutrition, group therapy or counseling.
  3. Prevention, Screening and Diagnostic Trials assess ways to reduce the chance of getting cancer in general. In these trials, which may be treatment or non-treatment trials, many participants do not have cancer, but some have had cancer and are at risk of it returning (recurring) or a second cancer developing. Sometimes these trials consist of simply completing questionnaires and providing medical information.

Each trial is carefully thought out, planned and performed in an extremely consistent manner so that all patients are treated exactly the same, from medication dosage and schedule to the frequency of follow-up appointments. Institutional review boards or ethics committees carefully set up safeguards to make sure that all patients in the clinical trial remain safe throughout the process. Whether you’re at a small rural hospital or a large facility in a metropolitan area, your medical team is responsible for diligently following all of the same protocols and safety measures for your treatment plan.

Benefits and risks

Clinical trials present several potential benefits, such as the opportunity to access leading-edge treatments that aren’t yet available on a widespread basis. They may be an alternative if your current treatment isn’t working as well as it once was, or if you have a rare type of sarcoma that hasn’t been studied as much as others. You will also be more closely monitored in a clinical trial because your regular oncologist and the clinical trial medical team will be attending to your needs. Even after the treatment ends, you will continue to be in close contact with the medical team.

At the same time, trials can present potential risks or inconveniences. Almost every type of cancer treatment has side effects, and the treatments used in clinical trials are no different. Ask your medical team about what to expect so you are not surprised by any effects. In addition, a clinical trial may require more frequent tests or medical visits, for example. Make sure you are aware of the necessary schedule associated with the trial to be sure you can accommodate it.

Cost is a common concern regarding clinical trials. Talk with your doctor or study team to learn more about the specific costs to you if you agree to participate in a clinical trial. You may find you can have access to an innovative treatment and be an integral part of cancer research without incurring a great deal of expense. Following are resources where you can search for clinical trials and learn more about them:


Understanding Informed Consent

Before volunteering for a clinical trial, you will receive detailed information about the clinical trial in an Informed Consent form. This form details the purpose of the research, including what your role will be in the trial and how the trial will work, as well as benefits, risks and other pertinent information. The form will include information about the trial and its goals, how you will be monitored and what side effects to expect, the best standard of care for your stage of disease (regardless of the doctor or institution), the safeguards in place and how to withdraw from the trial at any time. To ensure you fully understand what you are agreeing to, you are required to review the form during the Informed Consent process.

Before signing it, check with your insurance providers to determine what procedures are covered and what you will be expected or required to pay out of pocket. Although many trials cover the costs of certain treatments, other expenses may be the responsibility of the participant, which is best to know before you begin the trial.

You are encouraged to ask questions about anything you don’t fully understand. To help you make a more informed decision, talk with your medical team about the many falsehoods that persist about clinical trials. For example, although there is fear to the contrary, participants are guaranteed to receive, at minimum, the current standard of care treatment during the trial, meaning you never jeopardize your care by choosing to participate. Rest assured, you can continue to ask questions and share your concerns with your medical team throughout the trial. And, although you sign the Informed Consent form, you are not locked in. You may change your mind at any time during the trial and choose to receive standard of care.



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