Related Pages Boosting Cancer Trial Participation A collection of material about the barriers keeping people from participating in cancer clinical trials.

Cancer clinical trials have brought enormous advances in the areas of cancer prevention, treatment and diagnosis. However, less than 5 percent of adults diagnosed with cancer each year will get treated through enrollment in a clinical trial. With broader enrollment, the effort to find new and better ways to treat and prevent cancer might be swifter.

But, as suggested by two surveys and a series of focus groups, the vast majority of cancer patients are unaware of clinical trials and physicians aren't enrolling patients because they don't have the time, staff, or funding to do so.

"Any improvements in cancer care come from clinical trials," said Ezekiel J. Emanuel, M.D., Ph.D., chair of the Department of Clinical Bioethics at the National Institutes of Health and author of a 1999 study of oncologists' involvement in clinical trials sponsored by the American Society of Clinical Oncology (ASCO). "If we want to speed up trials and get more data, everybody involved -- researchers, funders, and patients -- can do more."

Missed Opportunities

In one survey completed in spring 2000 by Harris Interactive, Inc., eight out of 10 cancer patients were unaware that clinical trials could be an option for them.

The Harris survey included 5,980 cancer patients, 935 people without cancer (including 200 African Americans and 200 Hispanics), and 425 primary care physicians and oncologists. The survey was sponsored by the Coalition of National Cancer Cooperative Groups, Cancer Research Foundation of America, Oncology Nursing Society, and Cancer Leadership Council, an umbrella organization of patient advocacy groups.

Of the unaware patients, 76 percent said that if they had known about clinical trials, they would have been somewhat or very receptive to participate.

Members of the public showed a strong willingness to participate in clinical trials if they were diagnosed with cancer. Eight out of 10 said they would be willing to participate for their initial treatment. Almost nine out of 10 would be willing if their initial treatment failed.

Myth versus Reality

However, this enthusiasm did not carry over to patients facing real-life treatment decisions. Of those patients who knew about clinical trials, 71 percent chose not to participate.

Their reasoning was based mainly on misconceptions: fear of getting a placebo in place of actual treatment, belief that standard treatment is better than what they would be offered in a clinical trial and fear of being a "guinea pig."

In fact, placebos are rarely used in cancer treatment trials, and never in lieu of standard treatment, according to Robert L. Comis, M.D., president of the Coalition of National Cancer Cooperative Groups and chairman of the Eastern Cooperative Oncology Group in Philadelphia.

The concerns expressed by respondents who chose not to enter a clinical trial were not borne out by those who participated. The vast majority of patients surveyed by Harris who had participated in clinical trials said their experience was positive. Ninety-seven percent said they were treated with dignity and respect, and received excellent or good quality care. Eight out of 10 said they were not treated like guinea pigs and were not subjected to more tests and procedures than they thought necessary.

Three out of four said they would recommend participation in a clinical trial to someone else with cancer.

One in five non-participants said they were concerned their insurance might not pay. But for those who enrolled in clinical trials, 79 percent said their insurance company ultimately paid for the care they received.

"Fear is a greater barrier than the reality," Comis said.

Physician Bottleneck

In the Harris survey, most of the patients (67 percent) who participated in a clinical trial said that a doctor had a great deal of influence on their decision to participate. This means that barriers for doctors need serious attention.

The physician respondents to the Harris survey had very positive attitudes about clinical trials. Ninety percent of oncologists and more than 70 percent of primary care physicians said they believed clinical trials should be offered to patients at all stages of treatment, not just when standard treatments have failed.

In the second survey, sponsored by ASCO, the oncologists who responded were strong supporters of clinical trials. About 85 percent said they viewed clinical trials as the essential means of discovering new therapies to improve patient care.

On first glance, the 3,550 physician respondents to the ASCO survey appeared to have been active clinical trial recruiters. Eighty percent said they had enrolled a patient in a clinical study during the past three years.

But actual patient enrollment was far from ideal. The oncologists stated that 20 percent of their patients were eligible for a clinical trial. They approached half of those patients about enrolling, and just half of those, or 5 percent of their patients, were actually enrolled.

According to the ASCO survey, the big barriers for physicians relate to time, staff, and resources. Clinical trials involve more intensive collection and filing of patient information and data. In addition to the extra paperwork, sometimes staff may need additional training to complete necessary forms.

The cost to physicians for data management and other research expenses associated with enrolling a patient in a cancer clinical trial (Phase III) is about $2,000, according to the ASCO survey. Two-thirds of physicians also said eligibility criteria for patients are too restrictive.

When asked what would help them enroll patients, oncologists gave high marks to reduced paperwork, assured reimbursement of patient care costs, and more data management help. Protected time to do research appeared important as well. Those with protected time were more than twice as likely to enroll more than 5 percent of their patients on trials.

Role of Primary Care Physicians

Ninety percent of the primary care physicians who responded to the Harris survey stated they would like to see more of their patients participate in clinical trials. But a third study, suggests that primary care providers may not feel suited to handling clinical trial matters. In a series of NCI-sponsored focus groups conducted during June and July of 2000, 48 primary care physicians and nurse practitioners discussed their views regarding clinical trials.

Most of this group believed that oncologists were better suited to discuss cancer clinical trials with patients. The primary care providers didn't feel they had the time to learn about studies, discuss them with patients, or do the necessary paperwork. Some had the perception that clinical trials are inferior to standard care, appropriate only if other treatments fail. Also, many had misconceptions about placebos, concerned that their patients would be assigned to receive no treatment. Only one thought patients might get better care by participating in a trial

However, primary care providers did express a strong interest in learning more about trials studying the prevention of cancer, such as the Study of Tamoxifen and Raloxifene (STAR) to prevent breast cancer. They thought that if they had easy access to information about clinical trials in their local area, especially prevention trials, they would be better equipped to discuss trial participation with their patients.

Time for Action

"These surveys have defined the issues," Comis said. There is "enough information to move" toward three obvious targets: "We have to raise the level of awareness among patients and doctors, address the real, legitimate problems of the doctors, and bring the level of resources up to what is required."

Public awareness programs on cancer trials are being planned by the partners of the Summit Series on Clinical Trials, a group working to improve the understanding of cancer clinical trials and the National Dialogue on Cancer, a group that brings together principal leaders of key national cancer organizations, agencies and institutions from the public, private and non-profit areas. [Editor's note: In 2004, the group changed its name to C-Change.]

The National Cancer Institute (NCI) is doing its part, too. Under a new national system, the NCI hopes to change the way it develops, conducts, reviews and supports clinical trials.

Part of this new system includes the Cancer Trials Support Unit (CTSU),which is designed to make it easier to enrollment patients into clinical trials. The CTSU provides participating physicians with a single access point to the NCI's entire phase III clinical trials system, and helps with access to protocols, training, and educational information. Additionally, NCI is developing education initiatives to better inform physicians, nurses and the public about clinical trials.

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