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November 20, 2019

How to know whether a clinical trial is right for you

What to know about safety, costs and enrollment options

Adult Health Research
What to know before enrolling in a clinical trial Source/Image licensed from Ingram Image

Clinical trials may investigate new drugs, combination therapies, medical or digital health devices, or ways to manage symptoms and side effects of cancer treatments. Some clinical trials are trying to determine whether an existing treatment is useful in novel ways, such as for treating other cancer types.

More people are surviving cancer than ever before, largely due to the recent advances in treatment, screening and prevention. 

Every approved treatment available today is the result of a clinical trial, which is a research study involving volunteers and one of the most important tools we have that helps us find new and better ways to prevent, diagnose or treat cancer and other diseases.

Many people are unaware that clinical trials exist or that clinical trials may be an option for them. Some people are hesitant to join a clinical trial or have many questions.

Clinical trials may investigate new drugs, combination therapies, medical or digital health devices, or ways to manage symptoms and side effects of cancer treatments. Some clinical trials are trying to determine whether an existing treatment is useful in novel ways, such as for treating other cancer types.

The first question you might ask is why should I participate? There are many benefits to participating in a clinical trial. They may offer early access to leading-edge treatments that are not yet widely available. Your participation is also helping to advance research that might help others with cancer one day. 

Clinical trials unlock important information that will be used to better treat or prevent disease, and clinical trial volunteers play a vital role along with researchers and clinicians in bringing these discoveries to patients around the world.  

One of the most important questions people have about clinical trials is understandably about safety: How do we know that an experimental treatment is safe?

A clinical trial does not start in the clinic with patients; it is actually the final step in a long process. 

First, there is an idea that begins in a laboratory, which researchers work on for many years. A new drug has to be discovered or created, then tested in cellular and animal models to determine effectiveness and identify potential side effects. 

According to the American Cancer Society, a new drug is studied for at least six years before it makes it to a clinical trial, and very few new treatments are even found to be promising enough for people in a clinical trial.

If the idea still appears promising in the laboratory during preclinical studies, the researchers submit it to the U.S. Food and Drug Administration for approval to enroll people in a clinical trial. There are strict federal rules in place to ensure the safety of clinical trials. 

An Institutional Review Board reviews and approves all clinical trials before patients may enroll. An IRB is an independent committee comprised of physicians, scientists, lawyers, ethicists, nurses and others. They review and monitor biomedical research and ensure that all laws and protocols are being followed and that the rights and safety of everyone participating in the research are protected throughout the trial. 

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Karen E. Knudsen, Ph.D.

Like any drug or procedure, even common ones that have been available for years, there are risks with clinical trials. Your doctor will discuss any potential risks with you and help you determine whether the potential benefits outweigh any possible risks. Once you enroll in a clinical trial, you are very closely monitored. In addition to your doctor and regular care team, a research team will be monitoring you, providing even more oversight of your care plan.   

A common misconception is that clinical trials are a last resort for patients who have no other options. This is not the case, however. There are clinical trials available for nearly every type of cancer and for both early and advanced cancers. Each trial has eligibility requirements depending on myriad factors, including cancer type and stage, previous treatments, and overall medical history, but trials are open to anyone who fits the criteria. 

In fact, it is imperative that a diverse group of volunteers participate so that the clinical trial results represent the diverse group of patients who might need the new therapies one day. For example, years of research have shown us that people respond differently to treatments based on personal characteristics like their ethnicity, sex and genetic background, and yet participation is particularly low among certain sociodemographic groups, including black and Hispanic patients and adults aged 65 and older.

Patients are often worried about the costs associated with joining a clinical trial, particularly if they require additional tests or doctor’s visits. It is important to talk to the clinical trial coordinator and to check with your insurance carrier, but most costs related to the trial are covered by the clinical trial sponsor. These include extra visits and special tests, and some travel costs may be covered as well.

A common concern that patients have is that they could be given a placebo, or inactive medicine, and not receive any treatment. However, placebos are not used alone if an effective treatment exists. Even if you enroll in a clinical trial in which you do not know the treatment you are getting, you will be receiving the current standard of care at the very least.

It is important to note that clinical trials are not just for cancer. All new treatments for any disease must go through clinical trials before the FDA approves them. You can search for available clinical trials for cancer and other diseases through ClinicalTrials.gov, the registry maintained by the National Institutes of Health of all publicly and privately funded clinical studies conducted worldwide.

National Cancer Institute-designated cancer centers, like Sidney Kimmel Cancer Center – Jefferson Health, conduct hundreds of clinical trials. Many community hospitals and physicians in private practice may also participate in clinical trials, often working with an NCI-designated cancer center.

Deciding whether to participate in a clinical trial is an important decision. To learn more, talk to your health care provider. They can identify any clinical trials you might be eligible for and discuss the potential risks and benefits to help you make an informed decision about whether a clinical trial is right for you.

Karen E. Knudsen, Ph.D., enterprise director at the Sidney Kimmel Cancer Center – Jefferson Health, oversees cancer care and cancer research at all SKCC sites in the Greater Philadelphia region. She writes occasionally on topics related to cancer.

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