NEW YORKTo 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
organizations 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
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. Thats going to
take a lot of work, and it wont happen in 2 years, said
Susan Braun, president and CEO of the organization.
With a program called Clinical ResearchAffiliates Funding
Trials (CRAFT), the foundation has begun pilot studies to identify
barriers it might attack. The aim is to put dollars where
theyre 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.
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
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 Universitys 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 patients interest, whether she
would or would not be interested in participating in clinical
trials. Dr. Newman, assistant professor of surgery, M.D.
Andersons Nellie B. Connally Breast Center, said that it is the
physicians 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 thats a good idea for them is a very
time-consuming process, she said.
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 countrys
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
were 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, youve got to withdraw
her from the trial and move her on to whats most appropriate
for her, she said.
Ms. Rowden added, We cant underestimate how important the
physicians recommendation is to a woman when shes sorting
through all of the options and issues. What the physician says really
counts a lot in the womans mind.