NEWS

Surveys Identify Barriers to Participation in Clinical Trials

Robert Finn

First in a two-part series.

According to estimates, fewer than 3% of adults with cancer participate in clinical trials, a rate that has long been the subject of intense hand wringing in the clinical research community. Recent surveys of oncologists, people with cancer, and the general public are beginning to replace speculation about barriers to participation with hard data, and these data are suggesting concrete strategies for increasing enrollment.

The most recent of these surveys was conducted by Harris Interactive Inc. and co-sponsored by several groups, including the Coalition of National Cancer Cooperative Groups, the Cancer Research Foundation of America, the Cancer Leadership Council, and the Oncology Nursing Society. The survey included telephone interviews with a random sample of 1,000 adults, including oversamples of 200 African Americans and 200 Hispanics; telephone interviews with 538 cancer patients randomly selected from a sample of 250,000 people with cancer; online surveys of 5,377 additional people with cancer from this group; and interviews with a national sample of 200 primary-care physicians and 225 oncologists.

Robert L. Comis, M.D., president of the Coalition of National Cancer Cooperative Groups, presented some of the results of the survey at the 36th Annual Meeting of the American Society of Clinical Oncology in May. "I think the most surprising result was the level of unawareness of the opportunity to participate in clinical trials on the part of patients," Comis said. "Seventy-five percent of cancer patients said they were unaware, and 10% said they were unsure, so roughly 85% of patients were not aware they could participate in clinical trials as part of their care. We as an oncology community have to deal with this reality—that there is a tremendous lack of awareness on the part of the public of the clinical trial opportunity. It’s inconceivable that there aren’t extremely high numbers of patients in that 85% who would be potentially eligible for clinical trials."



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Dr. Robert L. Comis

 
Of the 14% of people with cancer who were aware of clinical trials as an option, 25% reported participating in a trial and 71% said they did not participate. Of aware patients who did not participate, 58% said they considered participating and 40% said they did not consider participating.

Despite the low level of participation in clinical trials documented in this survey, there was some encouraging news. Among the general public, 31% of respondents said they would be very willing to participate in a cancer clinical trial and 51% said they would be somewhat willing to participate. Among cancer patients previously unaware of clinical trials, 30% would be very willing and 44% would be somewhat willing to participate.

Patients who participated in clinical trials apparently were pleased with the experience, and virtually all said they were treated with dignity and respect and received good or excellent medical care. More than 75% would recommend participation to others. The major reasons for participating cited by patients were the belief that they would have access to the best quality care (76%), the belief that they would benefit future patients (72%), the belief that they would receive newer or better treatments (63%), and the belief that they would get more care and attention (40%).

On the other hand, patients who chose not to participate demonstrated that misconceptions about cancer clinical trials were common. Thirty-seven percent said they did not participate because the standard treatment was thought to be better, 31% cited a fear of receiving a placebo, 22% cited a fear of being treated like a guinea pig, and 21% cited the distance they would have to travel (see Stat Bite).

Comis pointed out that several of these reasons show that patients may have a very low level of understanding of cancer clinical trials. "The majority of patients—85%—go on phase III studies," he pointed out. "In that setting they always receive the standard of care as a minimum opportunity. And here they felt the standard of care would be better, and also they didn’t think they would receive it [in a clinical trial]." In addition, Comis said, "the fear of receiving a placebo is almost as high, and we never use placebos as the only treatment in a therapeutic cancer trial."

Ellen L. Stovall, president of the National Council for Cancer Survivorship, believes that public education can provide an antidote to such misconceptions. "I think that the facts stand for themselves, but they’re not well-presented to people with cancer. People with cancer—as well as people with other life-threatening illnesses—are not nearly as risk-averse as people with other chronic conditions might be."



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Ellen Stovall

 
Although 60% of nonparticipants express belief that their health insurance would not pay, surveys reveal that coverage does not provide a significant barrier to participation. This may come as a surprise to those who have fought for Federal and state legislation mandating clinical trial coverage. Among trial participants only 21% reported that it was difficult to obtain coverage, and in the end only 13% failed to obtain coverage. In a separate survey of 3,550 oncologists, released at the 1999 ASCO meeting by Ezekiel J. Emanuel, M.D., Ph.D., chair of NIH’s department of clinical bioethics, 90% stated that they received reimbursement from insurance companies for patients enrolled in research studies, and only 10% reported being denied authorization or reimbursement.

"The insurance companies, both private and public, are providing coverage," Comis noted. "They do it despite the language in their policies." However, Comis added, "The numbers don’t tell how hard it was for the doctor or the doctor’s staff to run through the hoops to get the patient covered, or how much of a ‘don’t-ask-don’t-tell’ component there is."

The recent survey also queried people with cancer about whom they would regard as a "very credible" source in a public education campaign on cancer clinical trials. At the top of the scale, 46% of patients cited not-for-profit advocacy groups, 45% cited patients who had participated in clinical trials, and 31% cited physicians who participated in clinical research. At the bottom of the scale, 9% cited government agencies and 8% cited pharmaceutical companies.

"I wasn’t surprised that they would trust cancer advocacy groups," said Stovall. "I was very surprised that they wouldn’t trust the [National Institutes of Health]. That bothered me a lot. And while I’m pleased that they would trust cancer advocacy organizations, I also worry about how much the cancer advocacy organizations feel they’re equipped to give out reliable information on clinical trials."

This distrust of government agencies apparently does not extend to oncologists. According to Emanuel, one surprising result of his 1999 survey was how favorable oncologists are toward research sponsored by the National Cancer Institute. "The fact of the matter is that even though they get paid more on average by the pharmaceutical industry, when [oncologists were] asked who does the best studies, it was NCI, the government-sponsored, cooperative-group arrangement. There was a huge reservoir of positive feeling toward NCI and the cooperative groups. To use the language of another discipline, that’s social capital that should not be squandered."

So what’s the next step? Are more surveys needed? No, said Comis, now is the time for action. "We have enough surveys. We have a million surveys. We have to stop doing surveys and start to figure out what we’re going to do."

Developing concrete strategies to increase enrollment will be a central focus of the fourth Cancer Summit meeting, to be held in Washington, D.C., this week—Oct. 4–6. One possible outcome for the meeting, said Comis, may be a recommendation for a massive public awareness campaign about clinical trials. As Comis puts it, "We have to get the word out to the patients and the public that this is a viable, important, integral component of high-quality cancer care."

In the next issue: Oncologists in overwhelming numbers are involved in clinical research, yet they’re enrolling only a fraction of eligible patients. What is being done to address this problem?


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