|
5. Barriers to Clinical Trial Participation
Barriers for Health Care Professionals
Barriers for General Population
Barriers for Diverse Populations
Cost Barriers
Learning Objectives
Compare and contrast benefits and risks of
participating in cancer clinical trials
Identify barriers that deter health care professionals from referring patients to clinical trials
Identify barriers for low participation in cancer clinical trials
Identify barriers that deter special populations
(ethnic minorities, people with limited proficiency in
English, elderly persons) from participating in clinical
trials
Recognize cost and insurance issues related to
participation in clinical trials
|
A 1999 press release from the American Society of Clinical
Oncologists revealed that only 3 percent of adults with cancer
participate in clinical trials - far fewer than the number needed to
answer the most pressing cancer questions quickly.
The reasons so few adults participate in clinical trials are
complex and involve both participant and professional issues. Ideas
to address these problems can be found in
Cancer Clinical Trials: A
Resource Guide for Outreach, Education, and Advocacy, also available
from NCI.
Lack of awareness of appropriate clinical trials. Physicians
are not always aware of available clinical trials. Some may not be
aware of the local resources, or some may assume that none would
be appropriate for their patients.
Unwillingness to "lose control" of a person's care. Most
doctors feel that the relationship they have with their patients
is very important. They want what is best for the patient, and if
the person must be referred elsewhere to participate in a trial,
doctors fear they may lose control of the person's care.
Belief that standard therapy is best. Many health care
providers may not adequately understand how clinical trials are
conducted or their importance. Some believe that the treatment in
clinical trials is not as good as the standard treatment. They
also might be uncomfortable admitting that there is uncertainty
about which treatment is best in a phase 3 clinical trial.
Belief that referring and/or participating in a clinical trial
adds an administrative burden. The length and details of most
research protocols may deter providers from participating in
clinical trials. The possibility of incurring additional costs and
expenses that might be inadequately reimbursed is a deterrent for
many.
Concerns about the person's care or how the person will react
to the suggestion of clinical trial participation.
Strategies for Addressing Barriers
- Provide checklists on patient charts with eligibility criteria, placing
posters with open protocols listed, or using abridged "protocol
pocket cards" with key inclusion and exclusion criteria.
- Dedicate one research nurse or research assistant to identifying and
screening participants, coordinating pre-enrollment tests, educating
participants about the protocol and process, and initiating the
informed consent and enrollment process.
- Access funding for clinical trial support. See the www.cancer.gov site
section on clinical trials, the CTSU site (www.ctsu.org), and the NCI
Cooperative Group sites for information.
Lack of awareness of clinical trials. Research has
consistently shown that most people with cancer are not aware of
the option to participate in clinical trials.
Lack of access to trials. The reality or the perception that
there are no trials nearby deters many potential participants. In
addition, seeking care at a distant trial site presents time and
travel barriers.
Fear, distrust, or suspicions of research. For many people,
the loss of control (not choosing their treatment) that comes with
entering a randomized trial is too great. Many also fear being
treated like "guinea pigs" or being "experimented upon," as well
as not receiving treatment for their cancer. People may have a
general lack of trust in the medical profession based on past
negative experiences or the knowledge of historical abuses of
research participants.
Practical or personal obstacles. Costs of being away from work
and family may be deterrents for some people. Others may not wish
to leave the care of their own physician. People from certain
racial or ethnic groups or who are medically underserved may feel
that care within a trial will not be sensitive to their needs.
Others may feel that recruitment strategies are not sensitive to
their needs. Still others may believe that standard care is better
than the treatment available in a trial.
Insurance or cost problems. Another deterrent is the fear of
being denied insurance coverage for participation in a clinical
trial. If a person is uninsured, the cost of trial participation
is an issue.
Unwillingness to go against personal physician's wishes.
|
A Survey on Clinical Trial Barriers
A survey of almost 6,000 people with cancer conducted in
2000 took a look at why so few adults participate in cancer
clinical trials. Some of the highlights included:
About 85 percent of people with cancer were either
unaware or unsure that participation in clinical trials was
an option, though about 75 percent of these people said they
would have been willing to enroll had they known it was
possible.
Of those who were aware of the clinical trial
option, most declined to participate because they believed
common myths about clinical trials. They either thought
that:
The medical treatment they would receive in a
clinical trial would be less effective than standard care
They might get a placebo
They would be treated like a "guinea pig"
Their insurance company would not cover costs
People who received treatment through a clinical
trial found it to be a very positive experience:
Ninety-seven percent said they were treated
with dignity and respect and that the quality of care
they received was "excellent" or "good"
Eighty-six percent said their treatment was covered
by insurance
Source: Harris Interactive. Health Care News 1(3)
[Poll].
(Available from
www.harrisinteractive.com/harris_poll/
Supported by the Coalition of National Cancer Cooperative
Groups, the Cancer Research Foundation of America, the
Cancer Leadership Council, and the Oncology Nursing
Society.
|
Additional barriers exist for people who are from certain
ethnic/racial backgrounds or who are medically underserved. The
following is not meant to be a comprehensive overview of all barriers
associated with clinical trials, and what is outlined should not be
generalized to all diverse populations.
Diverse U.S. Populations - Definitions
Diverse populations include minority ethnic and racial groups
designated by the U.S. Government, including:
American Indian or Alaska Native
Asian American
Black or African American
Hispanic or Latin American
Native Hawaiian or other Pacific Islander
Ethnically diverse populations are growing rapidly; in the 2000
Census, about 25 percent of the U.S. population reported their race
as something other than White.
The National Cancer Institute's working definition of diverse
populations also includes medically underserved populations.
Medically underserved populations are those that lack easy access to,
or don't make use of, high-quality cancer prevention, screening and
early detection, treatment, or rehabilitation services. These may
include people of any racial or ethnic group who live in rural areas,
or who have low income or literacy levels. Medically underserved
groups are generally characterized as experiencing higher cancer
mortality rates and insufficient participation rates in cancer
control programs.
Specific Barriers
Long-standing fear, apprehension, and skepticism exist among
some minority populations about medical research because of abuses
that have happened in the past (e.g., the legacy of the Tuskegee
syphilis study). Among these populations, there is often
widespread fear and distrust of the medical care system as a
result of discrimination, indifference, and disrespect. Many feel
that they do not want to give up rights or lose power in order to
be "experimented on." Others may be skeptical about the quality of
care that would be provided in a clinical trial. Some may find
that trial recruitment strategies are not sensitive to their
needs.
Doctors may not mention clinical trials as an option for
cancer care. As noted above, many physicians do not refer people
to clinical trials. Some physicians may avoid suggesting a
clinical trial to people who belong to racial or ethnic minorities
out of concern that people would see them as insensitive.
Moreover, some physicians may inadvertently discriminate against
older people or those from certain ethnic or cultural
backgrounds.
People from various cultural or ethnic backgrounds hold
different values and beliefs that may be different than principles
of Western medicine. Many people have cultural beliefs that
Western medicine cannot address their health concerns. Different
ethnic and cultural views of health and disease (e.g., fatalism,
family decisions about treatment, use of "traditional healers,"
prayer, herbal medicines, or use of complementary/alternative
health practices) may make clinical trials a less attractive
treatment option. For prevention trials, many may feel that the
risk of a potential disease and its consequences may be less
important than meeting daily needs.
Language or literacy barriers may make it difficult for some
people to understand and consider participating. The complexity of
forms, including informed consent documents, may also be a barrier
to those considering participation. Translation can also be
difficult if the person translating information has not had
specialized training.
Additional access problems confront many people. Depending on
where they live or their access to transportation, people may have
difficulty getting to a clinical trial site. Those with low
incomes may find it difficult to take time off work or find
appropriate childcare. Other barriers, such as a lack of health
insurance or a source of health care, clearly present difficulties
in accessing trials.
For some solutions to barriers for diverse populations, see NCI's Cancer Clinical Trials: A Resource Guide for Advocacy, Education, and Outreach.
The costs associated with clinical trials can be a barrier for
many professionals and the public. Physicians are often concerned
about reimbursement related to the expense of either caring for
people enrolled in trials or offering trials within their practice.
Potential trial participants often fear that their insurance company
will not cover participation. Those who are uninsured will need to
know how their participation in a trial will be covered.
There are two types of costs associated with clinical trials:
participant care costs and research costs.
Participant Care Costs
Participant care costs include:
-
Usual care costs, such as doctor visits, hospital
stays, clinical laboratory tests, and x-rays, occur whether
someone is participating in a trial or receiving standard
treatment.
Extra care costs are those associated with clinical
trial participation, such as additional tests that may be
required.
These costs may or may not be covered by a participant's health
plan.
Research Costs
Research costs include costs associated with conducting the trial,
such as:
Data collection and management
Research physician and nurse time
Analysis of results
Clinical laboratory tests and x-rays
Cost of the agent being tested
Most of the time, research costs are covered by the sponsoring
organization.
Health Plan Coverage
Health insurance companies and managed care plans do not always
cover all care costs in a clinical trial. What they do cover varies
by plan and by trial. Now that Medicare has developed a policy
explicitly covering the routine care costs of diagnostic and
treatment clinical trials, other insurers may follow suit.
Insurance companies often claim that paying for clinical trials
would be too costly. But recent studies (Bennet et al., 2000; Fireman
et al., 2000; Wagner et al., 1999) found that costs for participants
in clinical trials are not appreciably higher than costs for people
not enrolled in trials.
For coverage strategies for participants and professionals, see
the clinical trials section of www.cancer.gov. Some insurance
carriers that cover clinical trials will even help health care
professionals locate appropriate trials.
Established vs. Investigational Therapies
In general, the most important factor determining coverage of a
treatment is the health plan's judgment as to whether the therapy is
"established" or "investigational." Health plans usually consider a
treatment established if sufficient scientific data exist to show it
is safe and effective. If a health plan does not think sufficient
data exist, it may consider the service investigational. Thus, some
health plans, especially smaller ones, will not cover any costs
associated with a clinical trial. Policies vary widely, but in most
cases it helps to have someone from the research team initiate
discussions with the health plan.
Other Criteria
Health plans may specify other criteria a trial must meet in order
to be covered, for example:
Sponsorship: The trial must be sponsored by an
organization whose review and oversight procedures meet the health
plan's standards of scientific rigor.
Trial type and phase: The trial must be judged
"medically necessary" by the health plan; this determination is
made on a case-by-case basis. In some cases, the trial must be in
phase 3. While a plan may be willing to cover costs associated
with phase 3 trials, it may require documentation of known
benefits before covering a phase 1 or 2 trial. Participants may
have more difficulty getting coverage for costs associated with
prevention and screening trials because health plans are currently
less likely to have a review process in place for them.
Cost neutrality: The trial must be cost-neutral - that
is, it must not be significantly more expensive than treatments
the health plan considers standard.
Lack of standard therapy: The trial must offer treatment
of a cancer for which no standard therapy is available.
Facility and personnel qualifications: The facility and
medical staff must meet specific health plan qualifications for
conducting unusual services, especially intensive therapy such as
a bone marrow transplant (high-dose chemotherapy with bone
marrow/stem cell rescue).
Legislation and Policies
Despite interest at the Federal level, as of 2002, no legislation
has been passed to require private health plans to uniformly cover
all clinical trial costs. However, there have been several important
developments at the Federal level regarding clinical trial
coverage:
Medicare reimburses for all routine participant
care costs for its beneficiaries participating in clinical trials.
Beneficiaries of TRICARE, the Department of Defense's
health program, are covered for NCI-sponsored phase 2 and phase 3
prevention and treatment clinical trials.
The Department of Veterans Affairs (VA) allows eligible
veterans to participate in a broad range of NCI clinical trials
across the country. The agreement covers all phases and types of
NCI-sponsored trials.
Many States have also passed legislation or developed policies
that require health plans to cover clinical trial costs. For an
updated
legislation listing,
see the clinical trials section of the
NCI Web site cancer.gov.
Refer to the case study for a review and summary of content covered in this workbook.
Back to Top
< Previous Section | Next Section > |
