Common Myths About Clinical Trials 

Advances in cancer treatments depend on clinical trials of new drugs and other therapies. Nearly all cancer drugs in use today were tested in clinical trials.  

But in the United States, only 3 percent of cancer patients participate in these studies. Part of the reason is that there are many myths and misunderstandings that can keep patients from joining, despite the advantages clinical trials can offer. 

“There are many potential benefits to participating in a clinical trial, including being part of finding new drugs or combination of drugs to treat cancer,” says Jeffrey Meyerhardt, MD, MPH, Chief Clinical Research Officer at Dana-Farber.  

Myth: Patients on clinical trials receive placebos instead of an investigational treatment. 

Fact:  Cancer clinical trials rarely have patients receive only a placebo. Two examples of more likely scenarios include studies that compare the standard treatment, which is the currently accepted best available treatment, with a new, investigational drug or treatment, or studies that test different doses of an investigational drug. 

If there was any possibility you might receive a placebo, that would be very clear in the informed consent process. During this process, a member of the clinical trial team will explain the details of the trial to you, answer your questions, and make sure you consent to the process before enrolling you in the trial.  

Some trials that are testing new combinations of treatments might offer standard treatment plus the new treatment or standard treatment plus a placebo. In this case, the placebo is an addition to standard therapy. 

Learn more about how clinical trials move cancer treatment forward.  

Myth: Clinical trials are a last resort only after other treatments haven’t worked. 

Fact: There are many clinical trials testing innovative therapies as the first treatment for patients based on evidence that the innovative therapy might offer patients better results than current standard therapies. Your doctor will be able to help you understand what your options are and explain why a clinical trial might be a good option for you and where it might fit in with other lines of therapy. 

Myth: I will have to stop my standard therapy to participate in a clinical trial. 

Fact: Your care team usually won’t recommend that you stop standard therapy if it is working for you. The number one goal is for you to get the best treatment possible. 

For most trials testing therapies, however, you would not continue to receive other cancer therapy when you enter a trial. In some other studies, patients remain on standard therapy but provide other information through questionnaires or by having material from the tumor analyzed and stored in a tumor registry. 

You can leave a clinical trial at any time. Your participation in the trial is up to you. Your doctor will work with you to determine the next best steps for your care. 

Myth:  If I am found ineligible for a clinical trial, I won’t be able to participate in any other trials. 

Fact: Every trial has its own eligibility criteria. For example, a study of an investigational drug may require that the patient cannot be on other trials that are testing cancer treatments. But that doesn’t necessarily disqualify the person from some other kind of trial, including tumor banking studies, quality of life studies, supportive care trials. 

If you learn that one trial isn’t a good fit for you, ask your doctor if there are other options that might be better for you.   

Myth: I won’t have access to an investigational drug when the trial ends, even if it is working. 

Fact: Many trials will continue a patient on a trial as long as and the patient is benefiting from and tolerating the treatment. This varies from one trial to another and is spelled out during the informed consent process. Each research center has an institutional review board (IRB) that protects the rights and welfare of patients, and IRBs typically urge the drug company that provides a drug for a trial to continue to make the drug available if the drug is benefiting the patient.  

Myth: I will have to pay out of pocket for treatment received in a clinical trial because insurance won’t cover investigational therapy. 

Fact: Patients generally don’t need to pay for the treatments and special trial-related tests received during a clinical trial. Those costs are covered by the sponsor of the trial. Health insurance typically covers charges related to tests and treatments carried out during a clinical trial that would be done anyway for standard treatment. You will learn about any potential costs of participation in the trial during the informed consent process.  

Many states, including Massachusetts, require insurance companies to cover the cost of participation in a “qualifying cancer research intervention protocol.” Individuals who participate in research may still have to pay the deductibles associated with their standard of care treatment.   

Myth: Clinical trials are risky. What if I experience side effects or the treatment doesn’t work? 

Fact: Improvements in technology and a better understanding of cancer at the molecular level has led to improvements in the ability to develop drugs that work more effectively and reduce side effects. It has also improved the ability for oncologists to match patients to clinical trials with more precision. 

Early phase clinical trials, such as phase 1, involve testing a drug in humans for the first time, which may sound risky. But these trials test very low doses first and slowly increase the dose to help investigators find a dose that is safe. 

In later phase clinical trials, a safe starting dose for many patients has been determined. However, everyone’s body is different and processes drugs differently. As more patients are treated with an experimental drug, there is the chance that new side effects will be discovered. For this reason, patients in clinical trials often have more frequent appointments, and are closely monitored for signs of side effects. Some patients prefer to be on a trial because of the extra care and attention they receive. When participating in a trial, providers that are familiar with that trial will be involved in your care, often including research nurses that focus on clinical trials.  

If an investigational drug isn’t working for you, your clinical trial team will act in your best interest and work with you to determine the best next steps. 

Myths: Clinical trials aren’t for people like me. 

Fact: Clinical trials are for everyone. In fact, it is essential that clinical trials include people of different races, ancestries, zip codes, and socioeconomic status to make sure to understand how the new treatments being studied work in all people. 

About the Medical Reviewer

Dr. Meyerhardt received his MD from Yale School of Medicine in 1997. He completed a residency in internal medicine at Beth Israel Deaconness Medical Center, in Boston, followed by a medical oncology fellowship at DFCI. He joined the Gastrointestinal Cancer Center at DFCI in 2002..