Renal Cell Carcinoma

Understanding Clinical Trials

To advance medical knowledge, research is needed, and much of that research is done through clinical trials. The advancements made through clinical trials save lives and help health care providers develop the best standards of care.

Clinical trials to test new medications or approaches as first-line therapy (the primary treatment prescribed by your doctor), second-line therapy (the second treatment suggested if the first treatment stops working or if you’re experiencing unmanageable side effects) and adjuvant therapy (treatment given in addition to the primary treatment) for renal cell carcinoma (RCC) are ongoing. These trials are usually carried out at hospitals, universities, doctors’ offices and community clinics and can be in both large cities and rural towns.

You may consider participating in a clinical trial for any of the following reasons:

  1. Your current treatment may not be working as well as expected, and a clinical trial may be a worthwhile alternative.
  2. A clinical trial may significantly improve your quality of life. Discuss your situation with your medical team so they are aware of your expectations regarding side effects.
  3. You may have a rare type of RCC that hasn’t been studied as much as other types.
  4. By simply participating, you play an integral role in helping refine and improve the way millions of people with all types and stages of cancer are treated. You will not only help identify treatments that work, you’ll help eliminate those that don’t.

Learning more about clinical trials by talking with other people who have participated in a clinical trial may encourage you to volunteer. Keep in mind that not everyone responds to treatments in the same way, so you cannot expect an identical experience in terms of response to treatment, side effects, etc. But you can find out what it’s like to receive care within a clinical trial. Ask your doctor if a clinical trial is a treatment option for you. Regardless of the opinions and research you gather, participating in a clinical trial is ultimately your decision.

Find a Clinical Trial

Clinical trials are essential for evaluating new treatments for people with RCC. They are conducted under the care of physicians and other research professionals and are sponsored by government agencies, by individual doctors and health care groups, or by the pharmaceutical or biotechnology companies that developed the treatments. Begin to research potential clinical trials on your own, and share the information you find with your doctor. For a list of clinical trial resources to explore, click here.

Understanding Informed Consent

Before volunteering for a clinical trial, potential participants receive detailed information about the clinical trial in an Informed Consent form. This form details the purpose of the research, including what the participant’s role will be in the trial and how the trial will work. It also includes risks, benefits and other pertinent information to answer a potential participant’s questions. To ensure they fully understand what they are agreeing to, potential participants are required to review the form during the Informed Consent process.

The Informed Consent information should be explained in easy-to-understand language and will describe the study’s purpose, the length of time of the study, predictable risks, possible benefits, expectations, protocols, alternative beneficial procedures or treatments, the research subject’s rights, where more information can be found and additional questions about the research. The document will include some of the following information:

  • The trial and its goals.
  • How the participant will be monitored and what side effects to expect.
  • The best standard regimen of care for the participants’ stage of disease, regardless of the doctor or institution.
  • The safeguards in place. All clinical trial participants are protected by rules that apply nationwide to all facilities.
  • How to withdraw from the trial at any time.

The Informed Consent process should give the potential participants a reasonable amount of time to review the trial’s information and ask questions before volunteering. They should use this time to check with any insurance providers to determine what procedures are covered and what they are 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 participants, which would best be discovered before starting a trial.

Potential participants need to understand their role as “subjects of research” and not as patients. Although they may receive personal treatment, they are not guaranteed to benefit from the study. They may be exposed to unknown risks, and they are entering a study that may be very different from current standard medical practices.