Clinical Trials
What Are Clinical Trials?
Clinical trials are research studies that test if a treatment is safe and works well. They can help us learn how to prevent, diagnose, and treat diseases like cancer. Doctors and researchers use clinical trials to learn:
- How to make current treatments like medications or surgery techniques better
- If a new treatment works well to treat kidney cancer
- If a new treatment can improve symptoms
- What side effects a treatment has
Every discovery and advance in treating kidney cancer has been because of patients joining clinical trials. You can talk to your doctor about joining a clinical trial at any point during your treatment.
If you want to join a trial, it’s important to understand the risks and benefits:
- Benefits can be that you may get a new treatment that might work better than currently available treatments.
- The risks can be that you might get unknown side effects, or the treatment may not improve your kidney cancer.
Joining a trial doesn’t guarantee that your treatment will be successful. However, even if a trial’s treatment is not successful, the results can still add to what doctors know about kidney cancer and treatments. This can help improve and lengthen the lives of people with kidney cancer in the future. Clinical trial participation is voluntary and participants may withdraw from trials at any time for any reason-be sure to talk with your provider what your next steps should be once leaving a clinical trial.
Phases of Clinical Trials
To make sure that drugs or treatments are safely tested, every clinical trial moves through designated phases. If outcomes from any phase indicate unsafe side effects or show that treatment is not effective to treat the cancer or condition, the trial will not move to the next phase.
Since clinical trials are designed to answer specific research questions, there are typically specific criteria that determine who may participate during each phase. These criteria are set by the trial sponsor and can include age, type of cancer, stage, tumor histology, and treatment history and may change depending on the phase.
Types of Clinical Trials
Randomized
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.
Non-randomized
Non-randomized trials are when all patients in a trial are receiving an experimental therapy. This is frequently done for phase I and II trials. All participants in these trials are receiving the same investigational product. Sometimes patients may be divided into groups that are receiving different doses or different combinations of the same product, potentially in combination with standard therapies.
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.
Non-therapeutic
Non-therapeutic trials are when patients are being studied to answer a question to learn more about kidney cancer or treatment, but without receiving an experimental drug. This might include studying samples of tumor tissue, using new diagnostic imaging tools, or learning more about the effectiveness or side effects of a standard treatment.
Using Placebos in Clinical Trials
In a clinical trial, a placebo is an inactive product that resembles the investigational drug being tested but it has no treatment effect. A placebo may be used when testing to see how effective the investigational drug works compared to or together with an existing treatment regimen.
Clinical trials designed today to evaluate new cancer treatments rarely have a placebo-only option as it would be unethical to not provide treatment for a patient’s cancer. Patients participating in clinical trials will receive a medication or treatment to treat their cancer, but are not guaranteed to receive the investigational drug.
Benefits and Risks
Benefits
Risks
Some of the risks of participating in a clinical trial are:
- Uncertain treatment outcomes
- Uncertain side effects
- More procedures such as blood tests, biopsies, or scans
- More time spent at appointments
- Unknown expenses, especially in cases where trial funding may not cover all expenses
Find a Clinical Trial
KCA offers a searchable database that includes information about a trial’s purpose, what type of kidney cancer may be eligible for a trial, who may participate, and locations a trial is offered:
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.
References:
Information on this page last reviewed: January, 2025
Keep Learning:
The Kidney Cancer Association provides educational literature for anyone impacted by kidney cancer.