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.
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.
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.
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, 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.
Some of the benefits of participating in a clinical trial are:
Some of the risks of participating in a clinical trial are:
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.
Contact the KCA Patient Navigator Program for help navigating ClinicalTrials.gov and finding a suitable clinical trial. Your health care provider can help you evaluate trials and eligibility.
According to the National Cancer Institute, these are some important questions to ask if you are considering participating in a clinical trial.