Contributor: Josette Snyder, RN, MSN, AOCN
This is a tough question, and the answer won’t be the same for everyone. You must decide based on your own reasons after talking with your cancer care team and carefully weighing the pros and cons.
Before you say yes or no, make sure you understand these three key concepts.
What is a clinical trial?
In a clinical trial, medical researchers formally and scientifically test new types of treatment. The goal of a clinical trial, which is sometimes called a research study, is to find better ways to treat cancer.
In a clinical trial, physicians and researchers test new treatments and therapies, which can include:
- Surgery methods
- Radiation therapy
- Combinations of treatments
- Treatment methods
Clinical trials are divided into several phases, each of which investigates different aspects, such as what’s the best dose, or whether the drug works. A later-phase trial is one in which it’s been determined the therapy works.
Nearly every drug you have ever taken has been through a clinical trial to test whether it is safe and effective.
Clinical trials are safe
You may be concerned about being treated with an unproven therapy. That’s understandable.
It may help to know that clinical trials are just a small part of the research that goes into developing a new treatment for cancer. So even though the new treatment may be considered experimental, there is a long track record established before the therapy is tried out in humans.
For example, before reaching a clinical trial involving humans, a drug has to be created, purified, described and tested through cell and animal studies. Very few drugs show enough promise in these early stages to be tested in humans.
On average, a new cancer drug has been studied for at least six years before reaching clinical trials. Then it takes an average of eight years from the time a cancer drug enters clinical trials until the federal government approves it for use – if the research shows the drug to be safe and effective. Figuring out if the drug increases the number of years a patient lives after treatment takes even longer.
So if you consent to participate in a clinical trial, know that the therapy has had to meet a rigorous set of criteria to make it this far, and that researchers have good reason to think the treatment might offer a new option for cancer care.
There are benefits and risks
Each clinical trial is different in what they are investigating, and how far along they are in the process toward approval. But for the most part, all clinical trials share some potential benefits. Among them:
- You might help others by furthering cancer research.
- You might receive a treatment that’s safer or more effective than current options.
- You’ll probably get more attention from your health care team and more detailed monitoring of your condition and side effects.
At the same time, there may be downsides to being in a clinical trial. Among them:
- The new treatment may have unknown side effects or other risks, which may be worse than existing therapies.
- You may have inconveniences such as more frequent office visits and testing.
- If you take part in a randomized clinical trial, you may not have a choice about which treatment you get. If the study is a randomized blind study, you will not know which treatment you’re getting. This will be explained to you in detail before you decide.
If you’re deciding whether to participate in a clinical trial, be sure to ask questions and discuss your concerns with your doctor, nurse, social worker or other members of your cancer care team.
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Read more expert advice from the Cancer Answer Nurses on their blog.
Jamie Schwachter, BSN, MSN, NP-C and Josette Snyder, RN, MSN, AOCN are Advanced Practice Nurses for Cleveland Clinic Taussig Cancer Institute’s Cancer Answer Line