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Risks/benefits of a cancer trial from patient's view
IRBs should keep this difference in mind
When IRB members weigh risks and benefits of an oncology clinical trial, they need to put risks and benefits in perspective for this particular population, or else they'll err by being too cautious, an expert suggests.
"Cancer patients may be more willing to put up with risks in trials that have less to offer because there may be no good alternative for them," says Scott H. Kurtzman, MD, FACS, director of surgery and director of the surgical residency program at Waterbury Hospital in Waterbury, CT. Kurtzman also is a professor of surgery at the University of Connecticut School of Medicine in Farmington, CT.
"An informed adult is entitled to take risks in clinical trials," Kurtzman notes. "Often in cancer, neither of the alternatives are good, so informed people could make a decision to take a drug that might be toxic to them or likely will be toxic to them if it would give them a chance at a benefit."
IRB members should keep in mind that cancer patients typically have different characteristics than other people who have life-threatening illnesses, he says.
"For one thing, these are generally healthy patients to begin with," Kurtzman says. "This is as opposed to someone who has had diabetes or heart disease for many years and is in a debilitative state and couldn't tolerate drug toxicities."
Also, the general public perceives cancer differently than other diseases, he says.
"It's perceived as life or death — 'Either fix the cancer or I die,'" Kurtzman says.
This is a more urgent viewpoint than that of the diabetic or heart patient's perspective that they might live with their disease for a long time, he adds.
"Believe it or not, cancer patients are willing to accept chemotherapy that is very toxic even if there's only a one percent chance of survival," Kurtzman says. "Studies have shown that cancer patients are much more motivated to take risks because they see this disease as an imminent threat to their lives, with no good alternative, so they can handle discomfort and disability more than other patients."
So when IRB members review the risks and benefits in a cancer trial, they need to place themselves in the cancer patient's mindset, which is that a person is willing to make an investment in being miserable for a short period of time in exchange for the potential of a long-term survival, Kurtzman says.
The key to assessing a cancer trial's risks and benefits is to have an oncologist on the board and to look carefully at the study design, Kurtzman advises.
Look at the study design and ask these questions, he advises:
Another factor to consider is that cancer drugs do not have the same expected effect on everyone who takes them, Kurtzman says.
For instance, if 10 people have pneumonia, and the treatment is penicillin, then all 10 will get better if put on penicillin. But if 10 cancer patients are put on the same medication, two won't get better, and eight might, but doctors don't know from the outset which two won't get better, he explains.
"Since there's more variability in response, cancer is a more variable disease and there's more reason to do clinical trials," Kurtzman adds. "In the area of cancer, it's more reasonable and ethical for patients to participate in clinical trials because there is no regimen or treatment with absolute guaranteed success."
Another difference about cancer trials that IRBs often fail to consider is how the consent form is worded.
"We're usually asked to put into the consent form all of the complications from chemotherapy, while it's typical in other drug studies to not list all of the side effect, but only to list the more common ones," Kurtzman says.
Cancer patients know about the risks of chemotherapy and understand that in a clinical trial they're being randomized to one or two arms of a chemotherapy regimen, he explains.
"So when they read every detail in the consent form, they're just seeing it rehashed," Kurtzman says.
While it's not unreasonable to put in every detail of each side effect, it isn't necessary because the cancer patient is not going to learn about the toxic effects from the informed consent document, he adds.
It's also common for cancer patients to have some therapeutic misconception during these trials, and this should not worry IRB members, Kurtzman says.
"Every patient is sure he's going to be the survivor," Kurtzman says. "How much you feel obliged to take that away from him/her is a matter of personal choice and style."
Patients will need to be told that this is not a guarantee that they'll live, but to take away the person's hope that he will not be the one who will survive would be unkind, he says.
"I don't think you have to do that," Kurtzman says. "You don't want to misrepresent the trial or give the patient false hope, but you don't need to take away the fantasy that he's going to be a survivor."
On the positive side, cancer patients tend to be very motivated to follow their physician's instructions precisely, and are highly adherent, he says.
"People say, 'Oncology — isn't that a terrible field to be in?'" Kurtzman says. "I say, 'What if you're a cardiologist and you have a patient who is 400 pounds, smokes cigarettes, and lives on the couch all day? You tell him to stop smoking and lose weight and he says he doesn't know if he can do that.'"
A cancer patient will react to doctor's advice very differently, doing everything the doctor suggests even if it means putting up with toxic side effects, he adds.