The Truth About Cancer Clinical Trials
- Phase I: Researchers determine how a new treatment or a new combination of treatments affects the human body, the safe dose and how the treatment should be given.
- Phase II: The treatment, test or prevention and symptom management strategies are tested on a particular type of cancer.
- Phase III: The treatment or intervention is compared to the current standard treatment to see if the new strategy is as good or better.
"We can't advance the care of cancer patients without effective enrollment in clinical trials," notes Cleary.
The decision to participate in a clinical trial may be difficult and complex. Patients will get the highest quality care because current best standard treatment will be involved. If the new treatment works, they'll be among the first to get positive results. On the other hand, the treatment may not be as good as the "gold standard." And there could be side effects.
During the informed consent process, the research team explains the reason for the study, what to expect and the risks and benefits.
Cleary said patients often ask about the differences between the quality of care in standard versus experimental treatments and care.
"Patient care will not be affected if they choose not to go on the study. The care is of the same high quality regardless. If they change their minds after enrolling, they can withdraw at any time," Cleary states.
Federal laws and checks and balances within the UW Carbone Cancer Center make sure clinical trials are safe, according to Dr. Howard Bailey, medical oncologist and researcher. There must be careful review and approval of the clinical trial by a review panel of scientists as well as an institutional review board.
"As much as we want and need to advance clinical research and new therapies, our first job is to ensure we're lessening the risks and not harming them in the process," says Bailey.
Bailey cites an example of how clinical trials can effectively advance cancer treatment and care.
"We were among the first research centers to study what is known as Taxol (paclitaxel), a chemotherapy drug approved in 1994 for ovarian cancer. Our researchers had been working with it for 6 to 8 years before that," says Bailey.
Since then, the chemotherapy drug has been approved for breast, lung, bladder, prostate, melanoma, esophageal and other types of solid tumor cancers. Despite those advancements and the hundreds of on-going clinical trials available at the UW Carbone Cancer Center, many patients may not understand that experimental therapies could be an option for them.
According to recent research findings at the UW Carbone Cancer Center, 60 percent of newly diagnosed cancer patients say they were never told about clinical trials.
"That doesn't mean the patients' physicians didn't tell them about clinical trials," says Bailey. "It could be that patients don't hear anything else immediately after they've been told they have cancer."
Myths and Hurdles of Cancer Clinical Trials
Bailey and Cleary agree that there are some myths and hurdles that may discourage cancer patients from considering clinical trials - including potential costs.
Wisconsin recently passed a law requiring insurance coverage for patients who want to participate in clinical trials.
Bailey says when it comes to new treatments and medications, patients frequently are concerned they may be given a placebo or sugar pill instead of the treatment.
"On the cancer therapy side, it is very, very unusual to have placebo studies," says Bailey. "It might be a study where two treatments are being compared. Patients would be randomly assigned to a treatment and not have control of which treatment they're receiving. But they'll know which one they're getting,"
Cleary also says that not all clinical trials are attempts to cure cancer or "trick the disease." Some trials strive to enhance the quality of life for cancer patients.
"All the advances we need to make are not just related to disease treatment. There are many supporting oncology studies on symptom control and pain management that probably have a bigger impact on a larger number of cancer patients."
Cancer Clinical Trial Contact Information
If you're interested in a clinical trial, call Cancer Connect at (608) 262-5223 or (800) 622-8922.