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

Overview

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.

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.

Barriers for Health Care Professionals

• 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.

Barriers for General Population

• 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.

Barriers for Racially or Ethnically Diverse Populations

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.

Cost Barriers

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.*

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.

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.

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