4. Barriers to Clinical Trial Participation
Barriers for Health Care Professionals
Barriers for General Population
Barriers for Racially or Ethnically Diverse Populations
Cost Barriers
Exercise
Many people with cancer do not participate in clinical
trials. Common barriers to participating include lack of
awareness; lack of access; fear, distrust, or suspicion of
research; and financial and personal concerns.
Learning Objectives
By reading this section and completing the exercise, you
will be able to
|
Participation in Clinical Trials
"Only 3 percent of adult cancer patients in the United
States participate in clinical trials - far fewer than the
number needed to answer the most pressing cancer questions
quickly."*
Reflecting on the quote above, why do you think more
people don't participate in clinical trials? You may wish to print
this question for a reference.
__________________________________________________________
__________________________________________________________
__________________________________________________________
Compare your answer to the information in this
section.
* Excerpted from an American Society of Clinical Oncology news release, 1999.
|
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 to 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.
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 of 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. (2001). Health Care News, 1(3) [Poll]. Available from www.harrisinteractive.com
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 list 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.
More information about these groups, as well as ideas for
addressing these barriers, can be found in Cancer Clinical Trials:
A Resource Guide for Outreach, Education, and Advocacy.
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.
NCI's working definition of diverse
populations also includes medically underserved populations.
Medically underserved populations are those that lack easy or any
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 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. However, some physicians may
avoid suggesting a clinical trial to people who belong to racial
or ethnic minorities out of concern that they would seem
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 may
hold values and beliefs that may be different than those of Western
medicine. Many people have a cultural belief 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 in clinical trials. The complexity of
forms, including informed consent documents, may also be a barrier
to those considering participation in a clinical trial.
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 back and forth
from 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 solutions to barriers for racially and ethnically diverse populations, see NCI's Cancer Clinical Trials: A Resource Guide for Outreach, Education, and Advocacy.
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 expenses 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 their participation in a clinical trial. Those who are
uninsured will need to know how their participation in a trial will
be covered.
There are two types of costs are 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 or by a pharmaceutical company.
Health Plan Coverage - Treatment Trials
Health insurance companies and managed care providers do not
always cover all participant care costs in a study. What they cover
varies by plan and by trial. In general, the most important factor in
whether a treatment is covered is a health plan's judgment as to
whether the therapy is "established" or "investigational."
Health plans often claim that paying for clinical trials will be
too costly. However, several studies in 1999 and 2000 found that
participant care costs for clinical trials are not much higher than
costs for people who are not enrolled in trials.*
*Bennett, C. L., et al. (2000). Evaluating the financial impact of
clinical trials in oncology: Results from a pilot study from the
Association of American Cancer Institutes/Northwestern University
Clinical Trials Costs and Charges Project. Journal of Clinical
Oncology, 18, 2805-2810. Fireman, B., et al. (2000). Cost of care for
patients in cancer clinical trials. Journal of the National Cancer
Insitute, 92, 136-142. Wagner, J. L., et al. (1999). Incremental
costs of enrolling cancer patients in clinical trials: A
population-based study. Journal of the National Cancer Institute, 91,
847-853.
Health Plan Coverage - Chemoprevention Trials
Although participants receive prevention agents free of charge,
coverage for required medical tests is often at issue. For example,
pre-entry tests are paid for by the trial at some (but not all)
institutions. However, the individual may need a retest if the
pre-entry test shows any suspicious findings, and the retest costs
may not be covered. If a person belongs to a managed care
organization, coverage for the retest will be denied if the primary
care gatekeeper has not authorized it, regardless of other
considerations. In addition, some trials require certain preventive
screening tests annually, such as mammograms, but not all insurers
cover preventive screening tests for all participants.
In considering options, interested persons should ask trial
personnel what the experience to date has been in the trial they are
considering. They should ask specifically about the type of insurance
involved. People may even be able to get examples of how their
employer or managed care plan has responded.
Potential participants should call NCI's Cancer Information
Service at 1-800-4-CANCER or visit
cancer.gov/clinicaltrials/, which features tips and
information about organizations to help with clinical trials
coverage.
People considering a trial should work with a doctor or
social worker to get specific information from the facility
running the trial. They should ask questions such as:
What parts of treatment, if any, does the trial
provide free of charge?
What parts of treatment must be paid for by me or
by my health plan?
What is the situation for people who have no
health insurance?
Will my total charges be higher as a clinical
trial participant than if I opt for standard care?
How successful are you in getting insurers to
cover the patient care costs in the study I am
considering?
Are there other resources or organizations you can
recommend to help me meet the fees or to provide services
such as free transportation?
|
Legislation and Policies
Despite interest at the Federal level, as of 2001, no legislation
has been passed to require private third-party payers 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.
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
www.cancer.gov.
Barriers to Participation
|
|
A. Do doctors discuss clinical trials as options for their patients?
__________________________________________________________
__________________________________________________________
__________________________________________________________
B. If a doctor cannot or will not refer a person to a clinical trial, can the person or family make the call directly?
__________________________________________________________
__________________________________________________________
__________________________________________________________
C. Is it more expensive to participate in a clinical trial compared to standard treatment? Are clinical trials covered by insurance?
__________________________________________________________
__________________________________________________________
__________________________________________________________
D. Are chemoprevention trials covered by insurance? If so, will participants compromise their coverage by entering trials for those at "high risk" for cancer?
__________________________________________________________
__________________________________________________________
__________________________________________________________
Answers to Exercise 4
Back to Top
< Previous Section | Next Section > |