NEWS

Oncologist’s Role Critical To Clinical Trial Enrollment

Robert Finn

Second in a two-part series.

Although a public education campaign may help to increase patient awareness of cancer clinical trials, recent surveys suggest that it will be important to attack the problem of patient enrollment in trials on other fronts as well. In particular, the surveys indicate that the involvement of the patient’s oncologist is absolutely critical. The National Cancer Institute appears to be taking these data into account, introducing a number of initiatives to make participation in clinical trials easier and more convenient for physicians.

A recent Harris Interactive survey (presented at the 36th Annual Meeting of the American Society of Clinical Oncology in May) demonstrates that awareness of clinical trials is poor, even among people with cancer (see News, Oct. 4, p. 1556). Of 5,980 patients surveyed, fully 85% were unaware that participation in clinical trials might be an option.

Because every one of those patients has presumably had contact with an oncologist, this figure suggests that oncologists are not informing their patients of the clinical trial option. As Ellen L. Stovall, president of the National Coalition for Cancer Survivorship, put it, "Patients—especially the older generation of patients—look to their doctors to take the lead. And particularly when you have cancer, a lot of the skills you have when you go to buy a car or a refrigerator go right out the window: your ability to negotiate, your ability to communicate, your ability to be resourceful. Many people—including someone like General Schwartzkopf who you’d think could command anything—basically say the diagnosis brings them to their knees. They really do look to their doctors."

Oncologist Participation

And those oncologists are participating in trials. A 1999 survey of 3,550 oncologists (presented at ASCO’s 35th Annual Meeting in 1999) revealed that 80.2% of them had participated in one or more clinical trials within the previous 3 years. Oncologists in academic medical centers participate at a high rate, but fully 75% of oncologists in private practice had had involvement in clinical trials within the same 3-year period.

"The thing I found most surprising was the fact that research seemed to be so integral to oncologists’ perceptions, the fact that it was so key to the way they practice medicine," said Ezekiel J. Emanuel, M.D., Ph.D., chair of the Department of Clinical Bioethics at the National Institutes of Health, who presented the survey results. "If you look at most clinical subspecialists—say, cardiologists or pulmonologists—research is not part and parcel of what they do in private practice."



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Dr. Ezekiel J. Emanuel

 
On the other hand, noted Emanuel, "While 80% of oncologists participate in clinical research, they don’t do a huge amount of it. They may have a few patients enrolled. And that is the key message for increasing research. You’re not going to increase research by recruiting more docs. That’s not our problem. We’ve got the docs. We’ve got to get more patients per doctor."

Robert L. Comis, M.D., president of the Coalition of National Cancer Cooperative Groups, agreed. "If you ask the oncologists if they believe in clinical trials or participate in clinical trials or are committed to clinical trials, they all say yes. So I think there’s a dichotomy between what the oncologists honestly believe and how that fits into their practice."

There also appears to be somewhat of a disconnect between what patients think about clinical trials and what physicians think patients think. Comis, who presented the survey results at the more recent ASCO meeting, put it this way: "We found both from the public and from cancer patients who were unaware [of clinical trials as an option] that there was a strong willingness to consider participation, whereas the doctor feels there’s a strong reluctance."

Facing Fears

Douglas W. Blayney, M.D., is a medical oncologist in private practice in Pasadena, Calif. Although he actively recruits patients into clinical trials—and even employs 2.5 full-time staff members exclusively to manage his clinical trials—he admits that introducing the subject to patients can be tricky. "Part of it is the feeling that if I tell the patient as a doctor that the best way to determine their treatment is to flip a coin, they may lose confidence in me as a physician." Indeed, 57% of physicians surveyed believe that a patient’s fear of randomization was a major reason for nonparticipation. On the other hand, the recent survey showed that only 18% of patients who were aware of clinical trials but did not participate cited fear of randomization as a major reason. And, said physician assistant and patient advocate Lydia O. Rising, "If randomization is a barrier for someone, they could be encouraged to consider a phase I or phase II trial where they’re not randomized."

Rising also pointed out that one of the biggest reasons physicians fail to refer patients to clinical trials is a lack of time for explaining the clinical trials option: "The people who know about clinical trials don’t have the time. And the people who have the time—the patients—don’t know how to do it. In an ideal world you’d have a middle set of people who were specialists in this area." She suggested that more use be made of physician assistants and nurse practitioners in this regard.

Trying to Ease the Burden

And it is not just explaining the trials that is difficult. "Trials are a burden to conduct," Blayney noted, "and by and large the reimbursement isn’t the same as the amount of time spent taking care of patients. A lot of it is unreimbursed time. It does interrupt the work flow, and it interrupts the work flow of the office staff as well."

Emanuel’s survey supports this contention. "Money, while not pivotal, was an important issue. As the gap between the actual cost of studies and what docs are getting from the NCI increased, it was tougher for people to do interesting studies."

Asked what would help enroll patients, 86.9% of the oncologists Emanuel surveyed cited reduced paperwork in enrollment, 85.4% cited reduced paperwork for reporting data, 83.1% cited assured reimbursement of clinical costs for the doctors, 80.7% cited more help in data management, and 77.5% cited an increase in reimbursement for enrollment.

Help appears to be on the way. In recent months NCI has introduced several initiatives designed to make participation in clinical trials easier for oncologists. For example, NCI has established the Expanded Participation Project (http://light.emmes.com/epp/) that, among other things, will let oncologists participate in trials conducted by several cooperative groups and will provide centralized data management, easing the burden on physicians who may not be comfortable with complex data-collection requirements.

NCI has also established a pilot project called the Cancer Trials Support Unit (http://www.ctsu.org). The CTSU will allow members of cooperative groups to register for any CTSU trial, even ones sponsored by other cooperative groups; to download protocols, case report forms, and other documents; and to receive reimbursement for research costs. The CTSU currently includes a number of phase III clinical trials in its menu, and NCI says that more will be added regularly. Eventually CTSU will include information about patient enrollment, data reporting, credentialing of new NCI investigators, training, and some auditing and regulatory matters—all handled through its online system.

Easing the administrative burden is critical, said Comis, because "It’s not just the doctor, it’s the system. I think we have to educate the public and we have to make it easier for the doctor and his staff to get the information to the patient. It’s a lot easier not to put a patient on a clinical trial than to put a patient on a clinical trial. We have to somehow bring the practice of medicine and clinical trials into sync with one another."

And Blayney added, "I think it’s a duty we have as oncologists. I think many of the people who are drawn to oncology are drawn because they realize that in our professional lifetimes there’s going to be a lot of progress. This is the way we as doctors and scientists can help with the progress. It’s the right thing to do."



             
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