Understanding the Value of Clinical Trials
- Legendary Western actor John Wayne dominated the genre before passing away from stomach cancer at age 72 in 1979.
- Before his death, Wayne participated in a study of a new treatment option. These studies are called clinical trials, and they help doctors better understand cancer and discover more effective ways to treat it.
- They also give patients a chance to try a treatment before it's approved by the U.S. Food and Drug Administration (FDA), and that can potentially be life-changing for patients.
- Despite the great benefits that come from clinical trials, they also come with risks (like potential side effects that are not fully understood yet). People interested in participating in clinical trials must first talk with their doctor to see if they would be a good fit.
- For help finding a clinical trial that’s right for you, try our easy-to use Clinical Trial Finder.
When you think of Westerns, iconic actor John Wayne likely comes to mind, wearing an eye-catching cowboy hat atop a horse. During the Golden Age of television, westerns reigned supreme, and leading the helm was Wayne. Amid his success as an actor, privately he dealt with several health conditions before his passing from stomach cancer at the age of 72 in 1979.
"I enjoy life to the extremities of my capabilities," Wayne, or "Duke" as he was nicknamed after his dog, once said in an interview, according to the Washington Post.Read More
Wayne received an Oscar in 1970 for his role in "True Grit" and was nominated for an Oscar in "The Alamo" and "Sands of Iwo Jima".
Off-screen, the beloved actor was a father to seven children and dealt with health challenges, including cancer.
Wayne's bouts with cancer spanned 15 years before he died in 1979. He first had his left lung removed after doctors discovered a tumor in 1965.
According to Variety, Wayne went for a "routine gall bladder removal" in 1979 but doctors managed to find "malignant cancer and removed his stomach" in an hours-long operation.
Wayne died on June 11, 1979, at UCLA Medical Center about six months later, after the cancer metastasized, or spread, throughout his body. He was 72 and surrounded by family.
His family later established the John Wayne Cancer Institute, which helps others fight their cancer battles.
"Duke’s” Treatment Included a Study
Although John Wayne battled cancer for more than a decade, he was just as brave in real-life as fans knew him on-screen. As part of his treatment, Wayne participated in study that tried out a new kind of treatment (at the time).
"My dad told the doctors, 'If this is helpful, I'm going to help you afterward,' John Wayne's son Patrick said according to CR Magazine.
Studies of new treatment options are called clinical trials, and they are an important part of medicine for two reasons:
Clinical trials help doctors better understand cancer and discover more effective ways to treat it.
They also give patients a chance to try a treatment before it's approved by the U.S. Food and Drug Administration (FDA), and that can potentially be life-changing for patients.
WATCH: Clinical trials can be life-saving.
Dr. Beth Karlan is a gynecologic oncologist at UCLA Health. She says the goal with clinical trials is to advance cancer research to a point where the disease becomes akin to diabetes where it becomes a manageable condition.
"Clinical trials hopefully can benefit you, but is also providing very, very vital information to the whole scientific community about the effectiveness of these treatments," Dr. Karlan said.
"They can be lifesaving. We’ve seen many in the last few years of children and adults who have participated in trials and have had miraculous results," Dr. Karlan continued.
How Do Clinical Trials Work?
Within the U.S., all new drugs must go through clinical trials before the FDA approves them. Although the rewards of clinical trials can be great, they also come with risks. It's important to talk to your doctor about this before enrolling in a trial. Some risks to consider include:
- The risk of harm and/or side effects due to experimental treatments
- Researchers may be unaware of some potential side effects of experimental treatments
- The treatment may not work for you, even if it has worked for others
Before you enroll in a trial, you must be allowed to read the consent documents fully and to ask any questions you may have. The documents will likely contain the following:
- The purpose of the research
- Any risks and benefits expected from the research
- Information about procedures that may cause discomfort (like frequent blood tests)
- Any alternative procedures the patient might consider instead
- How the patient's information will be kept private
- How long the study is expected to take
- A form confirming you are participating in research voluntarily
- Whether any compensation or additional medical care is available if some sort of injury occurs
- The patient's rights (like the right to stop research in the middle of the trial)
- Contacts for any patient questions
Patients are allowed to walk away at any time during the trial. Understanding your rights as a voluntary patient is important before you take part in a clinical trial and understanding that the treatment may not work is crucial as well.
Clinical trials may also have no extra cost for the participants, as the study's sponsor may pay for the treatment and any additional care. Some sponsors even pay for travel to and from appointments or treatment centers. Patients should make sure they ask what exactly will be paid for before signing up to be part of a trial.
The Affordable Care Act also mandates that health insurance companies cover routine patient care costs while people are enrolled in clinical trials.
During treatment of an experimental drug in a clinical trial, while some participants receive the real thing, others do not. These participants receive a placebo.
The placebo is "an inactive substance or other intervention that looks the same as and is given the same way as, an active drug or treatment being tested. The effects of the active drug or other intervention are compared to the effects of the placebo," as defined by the National Cancer Institute.
In some cancer clinical trials that are "randomized," patients who enroll are randomly assigned to receive either a placebo or the new experimental drug being studied. If the clinical trial is "double-blinded," that means that neither the patients nor the doctors running the clinical trials know who's in which group. This is an important part of a clinical trial design because it creates a safeguard against bias and the possibility that results could be skewed.
It’s important to know that getting zero treatment isn't usually the reality of the "placebo arm" anyway.
Instead, when patients with life-threatening cancers enroll in randomized clinical trials, the two groups are often broken into the new, experimental drug and a "control" group that receives the "standard-of-care" treatment.
Treatments considered standard of care are those that are accepted by experts as the go-to treatment for specific cancer. Standard-of-care, in other words, is the most used treatment.
In many cases, it might involve a combination of chemotherapy, surgery, or radiationbut not always.
More on Clinical Trials
Do Clinical Trials Have Limits on Who Can Participate?
It's important to remember, just because you're willing to take part in a clinical trial doesn't necessarily mean you will be able to join. These trials have specific criteria that patients need to meet to take part.
Ultimately, even though these trials can have incredible results and provide you with access to cutting-edge therapies, these are controlled experiments.
For each trial, there will be certain inclusion and exclusion criteria.
Sometimes, patients may be excluded from certain trials if their cancer has spread to their brain. If the metastases aren't under control, the patient may be unable to participate because researchers are concerned that they won't be able to complete the whole study.
"Because of the way the study needs to be done, not only for safety reasons but also for scientific reasons where we’re trying to actually answer a question, we have to set up criteria for who can participate in the trial, even though it makes it difficult to find the patients who are eligible," Dr. Alana Welm from the Huntsman Cancer Institute Research South, previously explained to SurvivorNet.
"If we were to do a trial where we didn’t have certain inclusion criteria or certain exclusion criteria, the result would not be interpretable," Dr. Welm added.
How to Find a Clinical Trial
If you are interested in participating in a clinical trial, your first step should be to talk with your doctor. He or she can address many of your initial questions and help you determine if you would make for a good participant.
Another key part of clinical trials is finding the right one for you. SurvirorNet has a resource to help with this, called the Clinical Trial Finder.
The portal provides resourceful information to more than 103,000 active clinical trials. You can research this tool for yourself or someone else based on a few simple questions about your condition and location.