TUESDAY, Dec. 17, 2002 (HealthDayNews) -- Do you do it to benefit a patient today, or to benefit humanity at some unspecified time in the future?
That's the question physicians ask -- or should ask -- every time they recommend a patient for a clinical trial.
However, even though the stated purpose of clinical trials is to advance science and come up with better treatments for future generations, many cancer specialists believe the primary purpose is actually to benefit the patients in the trial, says a study in tomorrow's issue of the Journal of the National Cancer Institute.
"Up until now, we have really focused on designing clinical trials to help answer scientific questions about what the best interventions are," says Dr. Ruth Oratz, an associate professor of medicine at New York University School of Medicine and chairwoman of the ethics committee at NYU's Tisch Hospital.
"This study highlights a very important fact, which is that clinicians who participate in trials continue to make therapeutic benefits for patients a very high priority. I'm not sure that that is bad," she says.
The study authors mailed surveys to 1,120 oncologists around the United States to find out why they enrolled patients in clinical trials for cancer treatments and what they viewed as the main societal purpose of the trials.
Different cancer specialists had vastly different views on the topic. For instance, 64.1 percent of pediatric oncologists said they enrolled patients in trials to provide state-of-the-art treatment for them. Only 42.8 percent of medical oncologists and 25.2 percent of other cancer subspecialists reported the same motivation.
On the flip side of the coin, 40.5 percent of medical oncologists, 32.3 percent of pediatric oncologists and 62.6 percent of the other oncology subspecialists reported enrolling patients in clinical trials to improve future therapy.
More pediatric oncologists (38.2 percent) thought the societal purpose of clinical trials was to ensure state-of-the-art treatment for participants. Only 19.5 percent of medical oncologists and 13.1 percent of other cancer specialists felt this way.
Almost three-quarters (72.7 percent) of medical oncologists, 59.4 percent of pediatric oncologists and 81.9 percent of the other subspecialists reported enrolling patients to benefit future therapy.
"The most surprising thing was the differences among the specialties," says study author Dr. Steven Joffe, an instructor in pediatrics at the Dana-Farber Cancer Institute and Boston Children's Hospital in Boston. "We sort of theorized that that might be there, but to actually see it come back and be as distinct as it was took me a little bit by surprise."
The authors stress this study should not be taken as an indictment of clinical studies, or that trials have to be an either/or situation. Sometimes you can advance medicine and provide good care for trial participants.
"I don't come away from this with a negative opinion. I think trials are a very good thing for patients to consider," Joffe says. "You can make treatment and research line up quite well or line up very poorly. I think the cancer field has done quite a good job of designing things in a way that people get good care in trials. For that reason, I think trials are to be encouraged but there remains the danger of forgetting that there are two different things going on."
Physicians need to be aware that there is a potential for friction between the clinical and research objectives and to make sure patients are aware of the distinction, Joffe says.
"I think the wrong thing to do would be to recruit somebody to a trial by saying this is the best thing for you, leaving out discussion of the uncertainties," he adds. "The most important thing is for physician-investigators to be conscious of the fact that they are playing these two roles."
Some doctors feel the discussion is one of splitting hairs when there might not even be a hair to split.
"I'm a practicing oncologist for 17 years and have probably put over 700 patients in clinical research trials, and I have never felt conflicted about the two questions here," says Dr. Jay Brooks, chief of hematology/oncology at the Ochsner Clinic Foundation in New Orleans. "I don't look at this as a one-two and if it's one way it's unethical. If I don't feel the study is a good study, then I don't put my patient in the study."
If there are existing treatments available for a particular condition, clinical trials compare the experimental treatment against the best existing treatment. This means that all trial participants will not be left out in the cold: They will get either the best available treatment or a possibly cutting-edge new treatment.
"I think we're doing an excellent job in this country in trying to conduct well-designed and ethically appropriate clinical trials," Oratz says. "But we can do better."
What To Do
For more on clinical trials, visit the National Institutes of Health or CenterWatch. For more on clinical trials involving cancer research, check with the National Cancer Institute.
