Misconception

Education is key and one would expect that at a minimum your cancer physician and team would cover all of your FDA-approved options for your current situation. However, most cancer physicians don’t participate in research clinical trials, treat ALL types of cancer, and have very limited time with each patient to discuss options. Making it even more challenging, there are tens of thousands of clinical trials in the U.S. There are over 1,000 Prostate Cancer trials and Over 10,000 for Breast Cancer trials listed on the government clinical trials page. Unfortunately, these barriers often prohibit research options from being discussed. To be honest, if a patient is interested in the research trials as an option, unless they are under the care of a cancer research physician, the burden will fall on the patient and their family to seek out available clinical trials on their own.

Misconception

Many research trials are looking at treatments that are already FDA approved but are now being studied in another setting of that cancer, or another combination of treatments, or for another type of cancer. No drug is guaranteed to work and no drug is without risk of significant side effects. All patients respond differently to each treatment. However, whether a drug is FDA-approved or “experimental”, patients should only continue on a treatment if it is working and tolerable. So, whether a treatment is FDA-approved or experimental, the moment a treatment is no longer benefitting the patient or the patient is not tolerating the treatment, it should be stopped. Also, generally speaking, new treatments today are often developed “smarter” with the intention of targeting more cancer cells and less normal cells as compared to historical treatments such as chemotherapy.

Misconception

The development of a drug into an FDA-approved treatment progresses through 3 main phases of trials, each phase has a different purpose. Phase 1 trials are small trials at a few cancer centers. Phase 1 trials are trying to determine the effective and safe dose of the treatment to move forward. Phase 2 trials are larger trials at more cancer centers evaluating the effectiveness of the treatment in a particular type of cancer. Phase 3 trials are often hundreds to thousands of patients, involving physician research at many cancer centers, sometimes even global trials. There will never be a placebo for a Phase 1 or 2 trial. You will always receive the “real” treatment. Phase 3 trials are designed to compare the research treatment against the current standard of care. Some but not all Phase 3 trials may have a group of patients who receive a placebo instead of the real treatment. If there is no current standard, then the comparison could be the experimental treatment versus a placebo. However even in that scenario, if the treatment was outperforming the placebo significantly, the trial can be halted and the patients who were receiving the placebo may be given the experimental treatment long before it’s available to the public.

Misconception

When conducting a research trial each treatment, lab, procedure, physician visit, and image scan is determined whether to be considered Standard of Care (is approved and would be required even if you weren’t on the trial) or NON-Standard of Care, necessary only for the research trial (isn’t approved or you wouldn’t receive if you weren’t on the trial). Any Non-Standard of Care treatment or testing will be provided to the patient at NO cost. Only the Standard of Care treatments or testing would be submitted through the standard insurance. Often research trials may even pay the patient some stipend or cover travel, lodging, and meal expenses.

Misconception

Some research trials are blinded to which treatment a patient is receiving. These trials are less common. You would be notified upfront if you were to be blinded to the treatment. More trials are randomized where the study has a non-biased system to make sure the groups of patients being compared on the trial are as equal and balanced as possible (ie. age, cancer stage, etc). You will know which treatment you are selected to receive unless it is a “Blinded” trial. Critical though is that every patient on a trial understands that at any point that he or she does not want to participate in the trial any further they ALWAYS have the right and ability to stop and come off of the trial.

True

Research trials often require more testing, procedures and visits to your physician’s office. This extra monitoring is in ensure safety for patients and to learn all that needs to be learned about the research treatment. Many patients have extra comfort knowing they are being monitored more closely than they would if they were not on a research trial. Generally speaking, Imaging is the most proven way to determine if a treatment is working and the patient should stay on the treatment or whether a treatment is no longer working and treatment should be changed to another treatment. Imaging scans are typically done more frequent on a research trial, paid for by the trial, than would be done if only receiving standard-of-care treatments. This is done so researchers no more quickly and more accurately when a patient should stay on treatment or change treatments.

Misconception

Cancer research trials are available in all stages of cancers. Research trials are conducted in a very specific setting or stage of a particular cancer ranging from initial diagnosis all the way through to no options left. However, the path through all of these trials is a one-way street. As a patient’s cancer progresses and treatment options fail, a patient can’t enroll on research trials meant for earlier stages and treatments. Waiting until failing all of the standard “approved” treatments would significantly limit the research options a patient could consider. Patients can consider and enroll on multiple research trials sequentially, one after another if they so desire. After progressing on any cancer treatment, a patient would ideally step back and evaluate all of their next standard of care options and all of their research trial options for their current cancer situation.

Misconception

A cancer patient should only remain on any cancer treatment whether an approved, standard-of-care treatment or a research trial. If the treatment is working and is tolerable, then the treatment should be continued. The moment any treatment is no longer effective against the cancer or the patient is no longer tolerating the treatment, the treatment should be changed. No treatment whether FDA-approved or on a research trial is guaranteed to work or be tolerated, so in the eyes of the cancer physician they always need to be evaluating whether the treatment should be continued or changed. In addition, there are only a limited number of treatments approved for any cancer. Research trials offer more options and hope for those patients who have a cancer with limited approved treatments, want a treatment with potentially fewer side effects, or running out of options.

Misconception

Research trials are conducted for many reasons. Some are attempting to improve the cure rate of a cancer. Others are conducted to delay the time of the cancer progressing or make patients with advanced cancers live longer. Still other research trials are conducted to minimize side effects and improve quality of life of a patient on a particular treatment.

Misconception

During the time that you are on a research trial, your treatment will be managed by a cancer physician, Study Investigator, who has been selected to participate in the trial. Research trials are typically only conducted by cancer centers and physicians with significant experience at conducting these trials. If your current cancer physician conducts research trials your care would remain under that physician. However if you had to see a different cancer physician for a research trial, during the trial the Study Investigator would manage your cancer care. However they would remain in communication with your current cancer physician and once the trial was over then you would return to your current cancer physician.

Misconception

The cancer physician (study investigator) who enrolled you on the research trial must follow the trial protocol exactly as written and approved by the FDA to be conducted as a trial. Except for unusual circumstances such as bad travel weather for the patient or equipment failure are deviations from the protocol allowed. The treatment decision while on trial are written in the protocol. HOWEVER, it is important for patient on a research trial to realize that the study investigator ALWAYS has to do what is best for the patient and their safety even if it means varying from the protocol taking the patient off study.

Misconception

Research trials are a written protocol that ALL have been reviewed and vetted by the FDA, the physicians participating in the trial, and an IRB (Institutional Review Board) which is a panel of non-biased professionals including scientists, physicians, ethicists, and even patients that make sure to the best of their ability that the best interests of the patients are being met and every precaution is being made to minimize the risk of harming a patient. The FDA and IRBs have the ability to halt a research trial that is ongoing if newly discovered information puts a patient at risk.

Misconception

Unfortunately, no treat whether FDA-approved or experimental is guaranteed to work in all patients and any treatment can have potential side effects. Some FDA-approved cancer treatments may only work in a minority of patients, but if shown to improve survival, slow disease progression or minimize toxicities in a group of patients that treatment may be FDA-approved. It is clear that we have a long way to go to develop more effective treatments with few side effects for each cancer. Research clinical trials is the only path to accomplish that.

Misconception

It is true if a research trial meets its intended goals that it very well may receive FDA approval for all patients to benefit from. However, waiting for this to happen can take many years and most patients with advanced cancers don’t have the time to wait.