Every cancer has a limited number of cancer medications to treat or control it. The ONLY way to develop new treatments which can be used and approved for the general cancer population is to conduct and complete clinical research trials which allows for an FDA approval.
Sadly only 3% of cancer patients enroll on clinical research trials in the U.S. Many potentially beneficial treatments don't compete accrual and never make it for an FDA evaluation. If we can improve the number of patients choosing to enroll on a clinical trial then we can bring more cancer treatments to market faster and cheaper.
Why Don't More Cancer Patients Enroll on Clinical Research Trials?
"MYTHS & MISCONCEPTIONS"
1) "Don't all Oncologists have the same access to and knowledge about all clinical research trials available?"
Truth: Not all oncologists participate in research trials or have very limited clinical trial access.
Most oncologists rely on FDA standard of care treatments. There are over 21,000 active clinical research trials for cancers today in the U.S. Because of this vast mountain of information and rapidly changing treatment options, most oncologists can only provide standards of care. That is good care, but it may be outdated and may not be your best care.
Clinical trials allow for more potential treatments to have in your back pocket. Using Prostate cancer as an example, there are around 10 useful FDA approved medicines to control a non-curable prostate cancer for a patient until that patient's last breath. However, in 2020 there are over 1,300 active prostate cancer clinical research trials accruing. As I explain to my patients, if I have non-curable prostate cancer, I want the 10 FDA approved treatments, but I also want an Oncologist who has knowledge and more access to the 1,300 research options. Many oncologists may say they do research but may only have a trial or two open that doesn't even fit your cancer situation. When a pharmaceutical company has a new treatment to study, they hand pick only a few of the most reputable cancer centers with the most experience to perform that clinical trial. Often times at UCC we are one of only a couple sites around the U.S. that were chosen for a particular new drug.
2) "Aren't clinical research trials the last resort after you have failed all other treatments?"
Truth: Clinical research trials are available at every stage and situation of your cancer journey from initial diagnosis until your last treatment option.
At every treatment transition point along a patients cancer journey one should consider all options including what is the standard of care approach and what are all of the clinical trials that patient may qualify for are open at your center. If a clinical research treatment can be used, that may be prolonging life by delaying the use of the standards of care and saving those for another day.
3) "Don't all patients potentially get a placebo or "fake drug?"
Truth: The majority of clinical research trials have no group of patients on a placebo or "fake drug".
The only time a pharmaceutical sponsor or FDA would allow a clinical trial to potentially give a patient a placebo is if the patient will at least be receiving the standard of care with it. So if the standard of care is a hormone shot and there is a clinical trial investigating a potential new pill that may make the shot better everyone on the study would receive the hormone shot and half of the patients could receive the real study drug and half would receive a placebo. However, if they weren't on the study they would only be receiving the hormone shot alone. In the case where there is no standard of care towards the end of the disease when we are running out of options, then the patient could receive the placebo only.
There could even be benefit from a placebo. If you were on a study and happened to be in the group that was given a placebo, if at interim analyses, the real drug is discovered to be effective, the clinical trial could be halted and patients who were given a placebo would be given the real drug at no cost long before it would be available to the general cancer population.
4) "What if my insurance company doesn't pay for the research trial? Who pays for it?"
Truth: Cancer treatments on a clinical research trial are typically covered by the pharmaceutical sponsor conducting the trial and don't involve your insurance.
Any treatment that is not approved by the FDA will always be provided at no cost to the patient on the trial. If a treatment is FDA approved, depending on the clinical trial it may be paid for by the study or submitted as usual to your insurance. Clinical trials have the ability to save vast amounts of healthcare dollars for patients and for society.
5) "I might have terrible side effects on a clinical trial treatment. I don't want to be a Guinea Pig!"
Truth: No treatment, not even FDA approved treatments are without potential side effects and have to be used with caution.
The understanding and science behind how most new treatments are designed and developed are much more targeted to the cancer, leading to more effectiveness and fewer side effects such as targeting a specific gene mutation or your immune system and less like general chemotherapy of the past. With that said, no matter what treatment Dr. Luke plans for you whether a FDA approved therapy or a clinical research trial, Dr. Luke has 3 promises to keep while you are on a treatment:
1) You will continue the treatment only if it is working. Even if you are on a clinical trial that was expected to last 3 years if the treatment stops working after 6 months we will stop the treatment immediately and not continue on the trial.
2) You will continue the treatment only if it is not hurting you. If you are experiencing mild side effects we will likely manage and continue the treatment but if you are experiencing significant side effects the treatment will be modified or stopped.
3) You will only continue the treatment if it is not breaking your bank. Investigational treatments on a clinical research trial are given at no expense to the patients. This saves the patient from having to pay out of pocket for expensive treatments.
So if a treatment is Working, Not Hurting You, and Not Breaking Your Bank, whether it is called standard of care or a clinical trial starts to become less of an issue for most patients.
Your UCC Cancer Team brings all of the FDA approved standard of care treatments to the fight against your cancer. However, more than ANY other cancer center in the U.S., the UCC Cancer Team has the most access to the latest cutting edge clinical research trials providing potentially life-saving treatments. Cancer research is the only way to discover and utilize new treatments for cancer patients. The Urology Center's Research Team is Globally recognized as a leader by scientific thought leaders, patients and pharmaceutical companies Contact us today for the expert 2nd opinion that you deserve to see how we can bring the best fight against your cancer!Start Your Care