From Our 2011 Archives
Many Patients Don't Take Part in Cancer Studies
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Study Shows Doctors Often Fail to Tell Patients About Ongoing Clinical Trials
By Denise Mann
Reviewed by Laura J. Martin, MD
Feb. 11, 2011 -- Just an estimated 2% to 4% of adults who are newly diagnosed with cancer participate in clinical trials even though there are more than 8,000 such trials that are actively recruiting. One reason is that they may not know about these trials because their doctors may not tell them, suggests a new study in the Journal of the National Cancer Institute.
Of 1,522 doctors responding to a survey who treat colorectal and lung cancer, 56.7% said they had referred or enrolled at least one person in a clinical trial during the past year. Those doctors who saw more patients and who spent more time with new patients were among the most likely to refer their patients to clinical trials.
The survey was conducted by the Cancer Care Outcomes Research and Surveillance Consortium.
Medical oncologists and radiation oncologists were more likely to refer patients to clinical trials than surgeons. In addition, doctors who taught medical students or residents, and who were affiliated with a Community Clinical Oncology Program -- a network for community-based physicians to partner with academic investigators -- or a National Cancer Institute-designated cancer center were also more likely to refer patients to clinical trials.
"Low and slow accrual to cancer clinical trials limits the availability of state-of-the art therapies in routine clinical practice," conclude study researchers led by Carrie N. Klabunde, PhD, of the National Cancer Institute. "Closer examination of nonparticipating physicians in these settings might identify interventions that could be used to increase their willingness to participate in clinical trials."
Why Doctors Don't Tell Patients About Trials
The new study puts a number on something that the medical community has been aware of for a long time, says Leonard Saltz, MD, a medical oncologist specializing in colorectal cancer at Memorial Sloan-Kettering Cancer Center in New York City.
"The minor problem is that patients are declining the study, but the major problem is that patients are not being offered the studies," he says.
There are many reasons that doctors may fail to mention available clinical trials, Saltz says.
"It may be that a doctor doesn't have access to trials, and the patient would have to leave their practice to participate or have to travel," he says. "It may be that the doctor is simply unaware of what clinical trials are out there, and it takes a lot of time to find out, and that is not time that anyone reimburses them for."
Some patients may be unwilling to participate in clinical trials, but if they are unaware of these trials, they may not be able to make the most informed decision about their treatment.
"When a patient is diagnosed with any disease, especially one as terrifying as cancer, and hears that there is an established standard treatment, there is a tendency to tune out any limitations," Saltz says. "Doctors, wanting to be optimists, may not offer a whole lot of information on these limitations unless asked."
"There is also the tendency to think about trials only after all else has failed, but by this time many people are no longer candidates or are too sick to participate," he says.
Concern Over Random Treatment
Sometimes people are concerned that studies often randomly assign treatments to different groups of patients. Trials may compare standard care with the experimental treatment, but it is luck of the draw as to who gets which therapy.
"This is necessary, and the right way to do the study, but on the other hand, a fair number will say they are uncomfortable with it and not willing to leave the decision to chance," he says.
Informed consent on the part of the patient is critical, he says.
When discussing clinical trial participation, Saltz says, "If you go on the study, it is because we hope it will be the right thing for you, and we will evaluate as we go always have the right to opt out. You can never say a trial is better for a patient because if we knew it was better, it wouldn't be a trial."
While clinical trials have advanced cancer care, "first and foremost, you owe it to yourself and people around you to make the best decision for you," he says.
Making an Informed Decision
Lori M. Minasian, ND, the chief of the National Cancer Institute's Community Oncology and Prevention Trials Research Group, co-authored an editorial that accompanies the new study.
"Most people learn about clinical trials from their physicians, and many do Internet searches when they are looking for newer or better approaches than the standard approach and some hear about trials that use public advertisement to recruit specific patient populations," she says in an email.
If your doctor doesn't mention clinical trials, "the simplest approach for patients is to ask about the trials in the context of the treatment discussion or at the end of that discussion," she says.
The patient needs to know all their options to make an informed decision. "Many patients are willing to participate because they wish to try something better or they because they want to help the next generation, but clearly there are some who are afraid of participating or who are highly skeptical about participation," Minasian says.
Aman Buzdar, MD, vice president of clinical research at the University of Texas M.D. Anderson Cancer Center in Houston, says the new article is "right on target."
"It's important to educate physicians that we need more patients in clinical research and to inform the patient that participation may help them, but may advance the knowledge so that the next patient down the line gets the benefit of these types of therapies," Buzdar says.
Doctors have to take time to explain the upsides, downsides, and unknowns of both standard and experimental treatments to patients, he says.
"We must be very candid with the patient that there is preclinical data that the new treatment may be more effective or safer than the standard treatment, but we don't know," he says. "This may take one, two, or three visits and is time consuming."
SOURCES: Leonard Saltz, MD, medical oncologist, Memorial Sloan-Kettering Cancer Center, New York City.Lori M. Minasian, MD, chief, Community Oncology and Prevention Trials Research Group, National Cancer Institute, Bethesda, Md.Aman Buzdar, MD, vice president, clinical research, University of Texas M.D. Anderson Cancer Center, Houston.Klabunde, C.N. Journal of the National Cancer Institute, 2011; vol 103: pp 1-14.Minasian, L.M. Journal of the National Cancer Institute, 2011; vol 103: pp 357-358.
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