When you or a loved one is in critical need of medical care, the words "clinical trial" may, at first, seem downright scary.
It may seem like a last resort for some, but for others, a clinical trial offers hope.
According to the Society for Women's Health Research, 94 percent of Americans say their doctor has never talked to them about participating in a clinical trial.
There are both risks and benefits of participating in this type of medical research.
Jeanie Huelsman was upset when she learned her breast cancer had come back and that it was spreading throughout her body.
"Any woman when they hear - breast cancer - their life flashes in front of their eyes, they view it as a death sentence," said Dr. Steven Limentani, Director of Clinical Trials at the Levine Cancer Institute in Charlotte, N.C.
Huelsman took a deep breath when her doctor suggested she take part in a clinical trial, or a research study, for a new experimental pharmaceutical drug treatment.
"You think to yourself - Oh, does this mean it's near the end?" Huelsman said.
With a little boy to care for, she didn't want to play any games with her health.
Her biggest concern was feeling like a human guinea pig for the pursuit of science.
Many medical experts, however, say that's one of the biggest myths about clinical treatment trials.
Clinical trials are not always a last resort. They are offered to people with all types and stages of disease.
Sometimes, a clinical trial is suggested by an individual's physician. In other cases, patients must do research on their own to determine if a medical trial is offered for the health condition they have. The website www.clinicaltrials.gov is a great resource for many.
Taking part in any clinical trial is a big decision. All the risks and potential rewards are outlined in the study's informed consent paperwork.
By agreeing to participate in the HER2 Clinical trial, Huelsman was volunteering to receive treatment that wasn't available yet to the public.
She understood the new treatment may work better or worse than prior treatments she received, and that, maybe, the new treatment could cause unknown side effects.
But what if she received a placebo?
In a blind study, you don't know if you're receiving the new treatment or not.
With Stage 4 breast cancer, Huelsman was concerned that by taking part in the study she might only be given a 'sugar' pill or no treatment at all.
"The only time there would be a no-treatment arm is if there was no treatment," Dr. Limentani said.
With most clinical treatment trials, every treatment option is called an arm of the study. The standard of care is the control, or placebo arm, and the new treatment is the other arm.
So, if the standard treatment is to do nothing, then that would be the placebo arm.
But the standard of care for cancer is chemotherapy. So, at the very least, Huelsman was assured she would still be getting treatment to fight the spreading cancer in her body. She just wouldn't know if she was also receiving the new drug.
"Oh gosh, this is really scary, to not know what you're going to get, but it's also hopeful, too, because it could be a good thing," Huelsman said.
If Huelsman's condition worsened, she knew she could refuse to continue being part of the clinical trial.
That's because in all clinical trials, at any point, participation is always in the patient's hands.
"It's my decision to get off of this," Huelsman said.
Several weeks into the trial, Huelsman's new scans came back and her cancer had stopped spreading. The final results on the clinical treatment trial also came back.
"The benefit was double. One, patients did better. Two, treatment was less toxic," Dr. Limentani said referring to the HER2 clinical trial. "It's the one-two punch for trying to kill breast cancer cells."
Now this new targeted breast cancer therapy call Pertuzumab is FDA approved and women across the country will have access to what Huelsman describes a medical miracle.
"Knowing this is not necessarily a cure [for cancer], it's sure making me feel good," and Huelsman. "Knowing that I can go on and just keep going, makes me pretty darn happy!"
One of the other benefits of participating in a clinical trial is that it can, sometimes, significantly reduce your treatment costs.
Many of the tests and check-ups required while participating in a clinical trial are paid for by the trial's sponsor and health insurance often covers the rest.
The following information is from Dr. Steven Limentani, Director of Clinical Trials for Levine Cancer Institute located in Charlotte, NC.
The following information is from Jeanie Huelsman, the patient featured in our story.
The following information is from the website ClinicalTrials.gov (http://clinicaltrials.gov/ct2/info/understand).
The following information is from the National Cancer Institute.
The following information is from the U.S. Food and Drug Administration's website in an article entitled, Basic Questions about Clinical Trials (http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm121345.htm).
The following information is from the Mayo Clinic's website in an article entitled, Clinical trials: A chance to try new therapies (http://www.mayoclinic.com/health/clinical-trials/DI00033/).
The following information is from the Seattle Cancer Care Alliance in an article entitled, Clinical Studies – Myths vs. Facts (http://www.seattlecca.org/clinical-trial-myths.cfm).
The following information relates Jeanie Huelsman's clinical trial.
The following information was from a Yahoo.com article entitled FDA approves Perjeta.
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