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By Melissa Schorr
NEW YORK, Mar 15 (Reuters Health) - Doctors often fail to tell cancer patients about clinical trials of experimental treatments--and patients often decline to pursue them--despite the fact that people enrolled in such studies may have improved outcomes, a new study reports.
"The only way to make sure a drug or approach is better than the old approach is to test that in clinical trials," Dr. Primo Lara, Jr., an assistant professor of medicine at the UC Davis Medical Center, told Reuters Health. "Patients potentially have some personal gain from the clinical trial, although that's not guaranteed."
Lara and colleagues at the University of California Davis Cancer Center looked at 276 cancer patients to see what factors kept the patients from joining clinical trials. A recent analysis found that entering a clinical trial is often associated with a higher survival rate for patients, according to the report in the March 15th issue of the Journal of Clinical Oncology.
In this study, 14% of the cancer patients being tracked ended up enrolling in a clinical trial. But half the patients eligible for the experimental therapies turned down the opportunity. The study was funded by the American Cancer Society and UC Davis.
The physicians failed to refer 38% of the patients for experimental treatment, often because the doctor thought there was no applicable trial or the patient was too sick to participate.
The researchers note that there were over 100 trials available at the center during the 3-year study period and some might have been suitable for the patients. And while elderly patients and others in poor shape used to be routinely rejected for clinical trials, now, enrollment standards have become more liberal.
"We urge physicians to think about clinical trials before dismissing a patient as ineligible," Lara said. "A lot of these trials are now allowing patients with borderline status."
But half the patients who were told about clinical trials by their doctors and were found eligible to participate still declined to do so, citing a number of reasons. A third of these patients told their doctors they were interested in pursing other forms of treatment, either the current standard care or alternative therapies.
An additional 13% said they lived too far from the treatment center, while 8% said they were concerned they would be denied coverage by their insurance carrier. Finally, 5% said they were concerned that they would be placed in the group that does not receive the treatment being investigated.
Potential patients also need to be better educated about any potential fears or misconceptions of experimental treatments, Lara said. For example, even those cancer patients placed in the placebo arm of a clinical trial--the group given an inactive treatment--would get the placebo in addition to the current standard of care rather than no care at all.
Finally, legislation needs to mandate that private and government insurance cover patients' medical costs of joining clinical trials so insurance coverage is never an obstacle, Lara added.
"All these studies will never get off the ground if third party payers don't contribute," he said. "They'd rather patients get old therapies that don't work than pay for it."
SOURCE: Journal of Clinical Oncology 2001:19:1728-1733.
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