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Policy Opportunity Teams

The "themes" which emerged from the policy suggestions generated at the 2006 National Policy Roundtable Meeting were refined into policy suggestion categories and opportunity teams were formed around each category. These categories include:

1. Allocation of Research Funding Proportionate to Case Fatality and/or Disease Burden
   
   Because research funding is finite, it is important for federal agencies to determine their research priorities based on addressing: 1) those diseases where mortality is high for the general population or 2) specific subgroups where there is limited research being conducted by the private sector. One example would be pancreatic cancer, which had the lowest estimated 5-year survival rate regardless of stage at diagnosis from 1996-2002 [1].
   
   To place greater emphasis on disease-burden targeted funding for federally sponsored clinical trials, the National Institutes of Health and other federal agencies would need to build in a review process that examines the mortality and disparities burden by disease and assess gaps in research funding. This process would also necessitate greater collaboration with the pharmaceutical industry and other stakeholders about research priorities to ensure that federal and private funding of clinical trials research is complementary and not competitive.

2. Assuring Healthcare Coverage in Clinical Trials

   In 2000, the Center for Medicare and Medicaid Services was authorized to provide insurance coverage for routine care and related costs for Medicare beneficiaries’ participation in clinical trials. In July 2006, Center for Medicare and Medicaid Services re-opened discussion of this policy to further define the process, procedures, and standards for coverage in clinical trials. For Medicaid beneficiaries, there is no universal policy for states to cover clinical trial participation, but there are currently 19 states that provide coverage [2]. Also, while private insurers often cover patient care costs related to treatment, they seldom reimburse for investigational treatments or drugs [3, 4]. For those who are uninsured, participation in clinical trials is still unlikely even when the investigational treatment is free [5], due to the various associated costs of participation.
   In both 2005 and 2006, there were legislative bills introduced to the Congress pertaining to coverage for cancer clinical trials:
   
                   • Access to Clinical Trials Act
                   • The Patient Protection Act of 2005
   
   Developing new or expanding current clinical trial policies is necessary to assure health coverage for eligible or interested patients to participate. These policies have the potential to not only break down barriers to care in clinical trials, but also serve as a framework for universal health care coverage.

3. Education/Training - Institutional/Professional

   One cited reason for disparities in clinical trials research is that persons from underrepresented groups are not offered the option to participate while in the health care setting [6]. In addition, physicians report being unaware that clinical trials are available as one of the most common reasons they fail to refer patients to trials [7, 8]. Language and linguistic differences may also provide a serious barrier to provider – patient communications and attempts to recruit participants into clinical trials.
   
   Policies related to the education and training of health professionals has the potential to change this situation. To be most effective, education polices should extend to all healthcare professionals, not just those related to the clinical trials enterprise, and be longitudinal - from initial training through continuing medical education for practicing professionals. Ideally, curriculum evaluation standards should be identified through regulatory bodies and certification for individuals in direct patient care. In addition, policies related to requiring cultural competency training should also be considered to equip health care professionals with the knowledge of how to address potential cultural barriers that may prevent many from participating in clinical trials.

4. Education/Training - Public/Patients

   Research has shown that the general public is unaware of clinical trials as a treatment/prevention option or is misinformed about the clinical trials process [9]. Most U.S. adults agree that clinical research participants are making a significant contribution to science, however 49% also feel that research participants are gambling with their health and are treated like "guinea pigs [10]."
   
   Among the most underrepresented populations in clinical trials are the elderly, racial-ethnic minorities, and those that live in rural areas. Barriers faced by these populations that could be addressed through public and patient education programs include lack of awareness, cultural barriers, mistrust of the medical system and language/linguistic differences. While there are some successful, evidence-based interventions for clinical trials education, there remain opportunities for the initiation of policies that mandate comprehensive public/patient communication plans using a range of culturally appropriate messages and materials developed to build trust and effectively educate communities.

5. Fostering Community Input/Involvement and Relationships

   Certain populations, such as those with low income, the elderly, or those who live in rural areas have the lowest rates of clinical trials participation. One way to address these disparities is through building relationships with communities. Communities often feel that researchers only engage them in the research process when they need participants or have already secured research funding without their input [11]. Including individuals from the community in the development, review, and post-trial activities of clinical trials is critical to emphasizing the importance of their participation and buy-in on trials for their community. Policies should be established requiring demonstration projects to forge links between research centers and the community, or enhance existing ties. Other promising policies could be the implementation of community review boards on university Institutional Review Boards [12] or establishment of more definitive language on community representation, and in particular minority representation, on Institutional Review Boards.

6. Participant Navigation

   Patient navigation is a "process by which an individual—a patient navigator—guides patients with a suspicious finding through and around barriers in the complex cancer care system to help ensure timely diagnosis and treatment [13, 14]." As a result of growing national interest and advocacy efforts, Congress signed into law the Patient Navigator Outreach and Chronic Disease Prevention Act of 2005 authorizing the Health Research and Services Administration to provide patient navigation services to health disparity populations through a demonstration grant program. Services to be provided under these grants include informing and, when appropriate, facilitating enrollment of eligible patients into clinical trials. Congress has also funded the National Cancer Institute's Patient Navigation Research Program, as well as the Radiation Oncology Patient Navigation Program, which has as one of its goals to improve the quality of life of people with cancer in health disparity regions by reducing high attrition from clinical research trials. Findings from these research programs will enhance the current, limited knowledge of the role of patient navigators as it relates to clinical trials [15, 16].
   
   In addition to the federally funded initiatives, state legislation for patient navigation programs also exists. For example, Kentucky's state legislature appropriated funding for a program that uses a lay health worker model to help rural Kentucky residents navigate the complex health care system. Additionally, organizations like the American Cancer Society and the Susan G. Komen Foundation, provide resources for implementation of local patient navigation programs. While all of these types of programs are instrumental in assisting the needs of minorities and underserved patients, development and enforcement of relevant policies to ensure program sustainability are needed.

7. Pharmaceutical Partnerships

   It is estimated that 75% of the funding for clinical trials in the U.S. are from corporate sponsors [17]. For this reason, collaborations with the pharmaceutical industry are important to addressing disparities in clinical trials. One example of how policy can encourage research from the pharmaceutical industry through development of incentives is the Orphan Drug Act [Pub. L. 97-414]. This Act includes a variety of incentives to the pharmaceutical industry, including tax credits and 7-year market exclusivity, for undertaking the research and development of drugs for rare diseases or conditions. Therefore, in order to improve the participation of underrepresented groups in clinical trials, developing innovative and strategic policies that align with the needs of those who are underrepresented and goals of the pharmaceutical industry, is critical.

8. Publication-Related Policies

   In September 2004, the International Committee of Medical Journal Editors issued a policy requiring all clinical trials to be registered in a public trials registry before the trial can be considered for publication. The International Committee of Medical Journal Editors encourages other journals to adopt this policy, and feels strongly those clinical trial participants:
   
   "…deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care, and deserve to know that decisions about their care rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish" [18].
   
   Publication of research findings is how the research community advances scientific knowledge within its community and communicates to other interested audiences. Thus, policies developed and enforced by editorial boards plays a significant role in what research is published. Working with these boards may serve as a critical bridge to influencing the quality of the data collected by clinical researchers, including an increased visibility and consideration of the reporting and representation of underrepresented groups in clinical trials.

9. Regulatory Oversight and Enforcement

   The modification and enforcement of existing clinical trial policies (i.e. federal, state, local, institutional, etc.) has the potential for improving representation of underrepresented groups in clinical trials. For example, Congress mandated both the National Institutes of Health Revitalization Act of in 1993, and the Food & Drug Administration Modernization Act in 1997, to specifically address issues related to women and minority participation in clinical trials. Unfortunately to date, both the National Institutes of Health - and the Food & Drug Administration -funded research have failed to have patient participation from diverse population groups as mandated [19, 20].

The Policy Opportunity Teams formed around these categories will continue the task of refining suggestions from the 2006 National Policy Roundtable Meeting into final policy recommendations. The charter for each team will include the following elements: Purpose, Scope, Deliverables, Timeframe, Membership and Resources.

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