Myths About Clinical Trials for Cancer

Fact vs Fiction in Cancer Clinical Trials

scientist looking through a microscope
Do you know the truth about these myths about clinical trials?. National Cancer Institute

 Clinical trials are extremely important – they are the only way that new drugs and procedures to treat cancer become available. Despite this, only around 5 percent of cancer patients are involved in a clinical trial as a part of their treatment. Why? Myths about clinical trials, such as being a guinea pig have been circulated and even illustrated in comics. What are these myths and what are the facts about medical studies for cancer?

Myth #1 - You are a Guinea Pig

In contrast to their reputation at times, you are not a guinea pig if you participate in a clinical trial. But it does help to be aware of the phase of a clinical trial you are offered, and the purpose of that particular phase.

Most of the time a clinical trial involves the use of a treatment that has been used for many people already and may work better than standard treatments. A phase 3 trial - the phase of trials that usually have the greatest number of people enrolled – are done with the purpose of answering the question “does this treatment work better than the standard treatment, or does it have fewer side effects than the standard treatment?” Phase 3 is the last step before a medication is approved for use by the Food and Drug Administration (FDA) via the FDA approval process.

Before entering a phase 3 trial, phase 2 trials are conducted.  A phase 2 clinical trial is done to answer the question, “does this treatment work?”

Some of the time a clinical trial is done for the first time on humans after testing a medication or treatment on animals. These trials, phase 1 trials, are usually done with only a small number of people, and are designed to answer the question, “is this treatment safe?”

Before you choose to enter a clinical trial, the researchers will discuss with you the phase of the clinical trial you are looking at, what you may expect, and possible complications.

Overall, the vast majority of people with cancer - 97 percent - who participate in a clinical trial claim that it was a positive experience.

Myth #2 - You Should Only Participate in a Clinical Trial if Nothing Else is Working

Understanding the phases described above can help to answer this question. In some cases the answer may be yes – if nothing else is working a phase 1 trial may help you further research for others with your disease (and has a small chance of making a difference for you as well.) But usually, people participate in clinical trials for other reasons. Cancer clinical trials are available for people at all stages of their disease. With new research on the genetics of cancer -- and the subsequent development of targeted therapies (therapies that target specific abnormalities in cancer cells and often do so with fewer side effects than traditional chemotherapy) - it's likely that for some people a clinical trial may be recommended as the first treatment following diagnosis.

  

Myth #3 - A Clinical Trial is Done to See if People May Live Longer

This isn't really a myth. Sometimes clinical studies are done to see if people will survive longer with a new treatment. But some studies evaluate things other than survival, such as quality of life. For example, a drug may be tested in a clinical trial to see if it decreases the nausea from chemotherapy better than current treatments available. There are many other types of clinical trials as well. Some study methods to prevent cancer. Others look at ways to screen for or diagnose cancer.

Myth #4 - Once You Are in a Clinical Trial You Can’t Change Your Mind

If you are involved in a clinical trial you can quit taking part in the study anytime you wish to stop.

Myth #5 - You Won’t Know if You are Getting a New Drug or an Old Drug or a Placebo

Some clinical studies do have placebo group, but this doesn’t mean you at risk of receiving no treatment when a treatment that may help you is available. ​Placebos are rarely used in clinical trials to study cancer treatments, and if there is a possibility you will receive a placebo, you will be clearly informed. A placebo group may be used if a medication or procedure is being tested to see if it is more effective than doing nothing. And – if the investigational/experimental drug or procedure is clearly better than a placebo, a clinical trial will be stopped to allow those receiving a placebo to receive the shown-to-be effective treatment. 

It is true that many studies are “double-blinded.” This means that neither you nor your doctors know if you are receiving the standard treatment or the treatment being evaluated in the study. But again, if one treatment is found before the study is complete to be clearly superior – whether it is the study treatment or the standard treatment – the study will be interrupted to allow those who have been receiving what then appears to be an inferior treatment to receive the superior treatment. Learn more about understanding clinical trial terminology.

Myth #6 - A Clinical Trial Means You May Miss Out on Other Treatments

When you are evaluated for a clinical trial, and if a better treatment is available, you will be told this before participating in a trial. It is true that sometimes receiving a treatment – whether a standard treatment or a clinical studies treatment – means that you may be ineligible for a different clinical trial in the future. It is important to talk carefully with your oncologist and the researchers for the study to learn if there will be any limitation in the future if you participate in the trial.

Myth #7 - The Treatment You Will Receive is Better than Standard Treatment

In a clinical study, there is no guarantee that the treatment you will receive is better than the standard treatment available. That is the purpose of the clinical trial.  In some cases, for example, lung cancer patients with something called ALK-positive lung cancer, before an effective treatment was approved by the FDA, researchers could be fairly certain that this subset of people with lung cancer would do better on the clinical trial medication than with standard treatment.

Myth #7 - The Treatment You Will Receive is Worse than Standard Treatment

You don’t need to worry that you will receive a treatment thought to be inferior to the standard treatment for your cancer. That would be unethical. As noted above, if during a clinical trial an investigative drug or procedure is found to be clearly inferior to the standard treatment, those on the investigative treatment will be informed and allowed to then receive the standard treatment.

Myth #8 - Nobody Else Can Get a Treatment Found to Be Superior Until the Trial is Done

Sometimes, a treatment is found to be clearly superior to standard treatment before a clinical trial has been completed. Some people who are seriously ill are allowed to use the drug outside of a clinical trial through a process called "compassionate use" or expanded access.

Myth #9 - My Family and Friends Want Me to Be in a Trial So I Need to Participate

Participating in a clinical trial is a very personal decision. While you may welcome comments from your loved ones and health care providers, only you can decide if it is the right fit for you. Check out the benefits and risks of participating in a clinical trial.

Myth #10 - Your Oncologist Will Let You Know if You are a Candidate for a Clinical Trial

Often this is true. But it’s important to remember that oncologists are human. Nobody can be aware of every cancer clinical trial in progress anywhere in the world, and the exact requirements and restrictions for patients to be enrolled. It’s also important to note that clinical trials are not necessarily conducted at every cancer center.

Your doctor may recommend a clinical trial at your cancer center, or may recommend that you travel to another cancer center to take part in a trial. But it’s also possible to check on clinical trials for your particular cancer online. Since this can be confusing, there are also free matching services available in which a nurse navigator will talk with you and then try to fit your particular situation with clinical trials currently available.

Next Step - Learn More About Clinical Trials and Finding One That is Right for You

Sources

U.S. Food and Drug Administration. Learn About Expanded Access and Other Treatment Options. Updated 05/31/16. http://www.fda.gov/ForPatients/Other/default.htm

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