Program Aims to Increase Participation in Breast Cancer Trials

NEW YORK—To increase enrollment in clinical trials, the Susan G. Komen Breast Cancer Foundation of Dallas is launching a well-funded initiative. Issues to be addressed include overcoming barriers to participation by physicians as well as by patients, the organization’s founder, Nancy Brinker, said at a press briefing that included a panel of foundation leaders and physicians with expertise in clinical trials.

“Less than 3% of eligible breast cancer patients participate in clinical trials,” said Ms. Brinker, who set up the foundation in 1982 to honor the memory of her sister who died of the disease. In contrast, more than half of children who are diagnosed with cancer in this country end up on a clinical trial, said Nancy Davidson, MD, professor of oncology, Johns Hopkins Oncology Center, and chair of the breast cancer section of the Eastern Cooperative Oncology Group (ECOG).

In addition, other countries have higher adult enrollment in trials than the United States. For example, Dr. Davidson said, a Scandinavian trial of high-dose chemotherapy/bone marrow transplantation in breast cancer was able to enroll 70% of all women in its region with the type of disease being studied.

The foundation hopes to increase participation in breast cancer clinical trials to 15% to 20% of patients. “That’s going to take a lot of work, and it won’t happen in 2 years,” said Susan Braun, president and CEO of the organization.

With a program called Clinical Research—Affiliates Funding Trials (CRAFT), the foundation has begun pilot studies to identify barriers it might attack. The aim is to put “dollars where they’re needed,” said Diana Rowden, past chairman of the foundation. The grants, she said, may fund such things as taxi vouchers to help patients get to appointments or salaries for data managers and research nurses in physicians’ offices.

“If the Komen Foundation can make a grant to help support these critical people, data managers and research nurses,” she said, “it makes it possible for physicians in smaller communities or smaller hospitals to offer clinical trials.”

The pilot studies gathering localized information are being conducted by Komen Foundation affiliates in New York, Baltimore, Denver, Little Rock, Seattle, Wichita, Kansas, and Helena, Montana. In most instances, the study area extends beyond the city. The Baltimore study, for example, is looking at the entire state of Maryland.

The foundation has committed $200,000 for CRAFT startup costs and expects to roll out the program to its 114 affiliates next year. Ms. Braun estimated that funding for the program next year “will be at least $1 million.”

Infrastructure Cost

Research infrastructure costs in clinical trials for data managers, nurses, and physicians are $2,500 to $3,500 per case, but NCI funding for clinical trials runs only about $750 to $1,500 a case, said Robert L. Comis, MD, president of the Coalition of National Cancer Cooperative Groups and chair of the Eastern Cooperative Oncology Group (ECOG).

In publicly funded trials, therefore, “the doctors and nurses involved are basically donating half of their time,” said Dr. Comis, who is also director of Hahnemann University’s Cancer Clinical Trials Research Center, Philadelphia. In trials sponsored by the pharmaceutical industry, he said, funding tends to cover research infrastructure costs. Today, “the pharmaceutical industry is the driving engine for discovery in cancer.”

Patient care costs in clinical trials are essentially the same as for standard treatment, Dr. Comis said. Efforts are being made, he added, to guarantee coverage by third-party payers.

Barriers to patient enrollment identified by Dr. Comis include fear of being given a placebo. “Cancer trials do not include a placebo but always the best treatment available as a comparative to newer approaches,” he stressed.

Some patients, Dr. Davidson added, see clinical trials as a last resort and are unaware that they are conducted along the continuum of the disease. “My doctor never even mentioned it to me” is another factor identified in patient surveys, Dr. Comis commented.

Lisa A. Newman, MD, said that “none of us should assume, based on our perception of a given patient’s interest, whether she would or would not be interested in participating in clinical trials.” Dr. Newman, assistant professor of surgery, M.D. Anderson’s Nellie B. Connally Breast Center, said that it is the physician’s obligation to inform patients of all of the treatment options available, including possible trial participation.

“It is the women who are not asking questions whom we need to spend the most time with, to make sure they have a clear-cut understanding of their options and alternatives,” she said.

Dr. Davidson noted that “doctors lose money from trial participation, so from a financial perspective, there is seldom any incentive to make the extra effort to talk to patients about trials.” However, she sees the primary barrier to participation for physicians as lack of time. “Presenting a clinical trial and explaining to somebody why that’s a good idea for them is a very time-consuming process,” she said.

Outreach Person

One solution suggested by the New York CRAFT study is an outreach person, said Lynne Abraham, a founder of the Komen New York Race for the Cure. Several physicians’ offices, she said, might share such a person, who would explain “what clinical trials are about” and also reach out to bring people into trials.

Noting that women of higher socioeconomic status are more likely to know about the option of entering clinical trials, Dr. Newman urged that this not be the only population to benefit from them. “If we are going to be able to prove to ourselves that the treatment strategies we develop in these clinical trials are applicable to the broader, more diverse segments of this country’s communities,” she said, “we have to get the women of all socioeconomic strata to participate.”

For physicians, Dr. Comis said, another barrier is the perception that clinical trials interfere with the doctor-patient relationship. Obtaining informed consent can be difficult because of the length of the documents involved. “That whole process is being redone, and we’re trying to make things simpler,” he said. Randomization is also seen by some as interfering with the relationship, he said.

The first obligation of all participating physicians, Dr. Davidson stressed, is to the patient. “The moment you think that the trial is no longer in her best interest, you’ve got to withdraw her from the trial and move her on to what’s most appropriate for her,” she said.

Ms. Rowden added, “We can’t underestimate how important the physician’s recommendation is to a woman when she’s sorting through all of the options and issues. What the physician says really counts a lot in the woman’s mind.”