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Clinical trials are research studies that involve patient participants. They are designed to answer specific questions about the safety and effectiveness of new drugs, procedures, surgical techniques, or medical devices.

Clinical trials are the primary tools for us to better understand kidney cancer and what may or may not work to prevent it, treat it, or manage its symptoms and side effects – they seek to answer research questions no one knows the answer to yet. Because of this, there is a degree of uncertainty when it comes to participating in a clinical trial. It’s important for potential participants to thoroughly understand the risks and benefits involved.

Clinical trial participation is voluntary and participants may withdraw from trials at any time for any reason.

Participating in a clinical trial does not guarantee a desired result or outcome but the findings add to the medical knowledge about kidney cancer and its treatment and can help improve and prolong the lives of future patients.

Types of Clinical Trials

Clinical trials fall into one of several categories:

Phase I trials are the initial studies of drugs or treatments designed to establish the safest dose, decide how the new treatment should be given, and see how the body and the cancer cells are affected.

Phase II trials determine if the new treatment is effective against a particular type of cancer and continue to monitor how the body is affected by the treatment.

Phase III trials compare a new treatment or new use of a treatment with the current standard treatment.

Since clinical trials are designed to answer specific research questions, there are typically specific criteria that determine who may participate. These criteria are set by the trial’s study sponsor and can include age, type of cancer, stage, tumor histology, and treatment history, for example.

Randomized Clinical Trials

Randomized trials are when patients are directed into one of two or more treatment categories using a random selection technique to ensure the validity of the trial results. Participants in phase III trials and occasionally phase II trials are typically randomized to compare two or more treatments and may include a placebo group.

Placebo Group

In a clinical trial, a placebo is an inactive product that resembles the product being tested but it has no treatment effect. Placebos are an efficient way to demonstrate the effectiveness of a new treatment. Trial participants are told if there is a placebo group as part of the trial design, but they may not know whether they will be part of an active treatment group or the placebo group. Phase II and III trials might include a placebo group if there is no standard treatment against which to compare a new drug.

Blinded

Blinded, or masked, trials are designed to prevent the research team and the participants from influencing the study results and reducing bias by withholding some information. In a blinded trial, the research team knows which participants are getting which treatment, but participants do not know. In a double-blind trial, neither the research team nor the participants knows who is receiving which treatment.

Benefits

Some of the benefits of participating in a clinical trial are:

  • Access to new treatments that may be more effective than what is currently approved by the FDA/EMA
  • Receiving investigational treatments at no cost.
  • Contributing to medical progress

Risks

Some of the risks of participating in a clinical trial are:

  • Uncertain treatment outcomes
  • Side effects from an experimental treatment
  • More procedures such as blood tests or biopsies
  • More time and expense, especially in cases where trial funding may not cover all expenses

Finding a Trial

Asking your healthcare team about clinical trials is a good way to begin gathering information about what clinical trials are and whether there are ongoing clinical trials that might be right for you.

The most comprehensive database of clinical trials conducted around the world is available at www.clinicaltrials.gov. This searchable database includes information about a trial’s purpose, who may participate, where the trial locations are, and who to contact for further details about the trial and eligibility criteria. Your health care provider can help you evaluate trials and eligibility.

Important questions to ask about clinical trials

According to the National Cancer Institute, these are some important questions to ask if you are considering participating in a clinical trial.

Questions about the Trial:

  • What is the purpose of the trial?
  • Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
  • How long will I be in the trial?
  • What kinds of tests and treatments are involved?
  • How will the doctor know if the treatment is working?
  • How will I be told about the trial’s results?
  • How long do I have to make up my mind about joining this trial?
  • Who can I speak with about questions I have during and after the trial?
  • Who will be in charge of my care?
  • Is there someone I can talk to who has been in the trial?

Questions about Risks and Benefits

  • What are the possible side effects or risks of the new treatment?
  • What are the possible benefits?
  • How do the possible risks and benefits of this trial compare to those of the standard treatment?

Questions about Your Rights

  • How will my health information be kept private?
  • What happens if I decide to leave the trial?

Questions about Costs

  • Will I have to pay for any of the treatments or tests?
  • What costs will my health insurance cover?
  • Who pays if I’m injured in the trial?
  • Who can help answer any questions from my insurance company?

Questions about Daily Life

  • How could the trial affect my daily life?
  • How often will I have to come to the hospital or clinic?
  • Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
  • Will I have to travel long distances?
  • Will I have check-ups after the trial?

Questions about Comparing Choices

  • What are my other treatment choices, including standard treatments?
  • How does the treatment I would receive in this trial compare with the other treatment choices?
  • What will happen to my cancer without treatment?