PANEL DISCUSSION III—BEST MECHANISMS FOR MOVING RESEARCH INTO COMMUNITIES
INTRODUCTION—DR. ROBERT L. COMIS
Background
Dr. Comis is President and Chairman of the Coalition of National Cancer Cooperative Groups, Inc. He is also a Professor of Medicine and Director of the Drexel University Clinical Trials Research Center in Philadelphia, as well as Group Chair of the Eastern Cooperative Oncology Group (ECOG). He currently serves on the Boards of Directors of the American Society of Clinical Oncology (ASCO), National Coalition for Cancer Research, and the American Radium Society. Dr. Comis received his medical degree from the State University of New York (SUNY) Health Science Center School of Medicine in Syracuse, New York.
Dr. Comis introduced the panel members.
DR. LUCILE ADAMS-CAMPBELL
Background
Dr. Adams-Campbell, Director of the Howard University Cancer Center, is currently the only African-American woman director of a Cancer Center in the country. She is a tenured Professor of Medicine, Graduate Professor of Psychology, and Associate Professor of Physiology and Biophysics at Howard University. She received her Ph.D. in Epidemiology from the Graduate School of Public Health at the University of Pittsburgh in 1983 and was the first African-American female in the country to receive a Ph.D. in Epidemiology.
Key Points
-
Many factors contribute to cancer health disparities, including differences in socioeconomic status and health insurance coverage. However, these factors alone do not account for the differences in incidence and outcomes of disease. Unequal treatment as a result of explicit and implicit racism, as well as socioeconomic factors—primarily income and educational level—also plays a large role in these inequities.
-
There are a number of successful mechanisms for effective cancer prevention and control targeted at underserved African-American communities. These programs demonstrate the importance of linkages between academic practices and grassroots community groups in working together to diminish the social causes of health disparities. One of these mechanisms is community participation in the development, implementation, and evaluation of programs. Directly engaging communities is necessary.
-
Materials, including brochures, should be designed with the specific target community in mind. Cultural appropriateness and sensitivity are often overlooked and low literacy levels must be considered, as patients often throw away materials they cannot read or do not understand.
-
Program sustainability and longer-term community involvement are very important and should be improved upon. Many grants are for from 3 to 5 years, which is not long enough to sustain relationships with communities. The only way to effect change permanently is through successful long-term community-based partnerships. Sustainability includes not only financial resources, but true community involvement. For instance, Howard University Cancer Center hosts a public health lecture series held in community churches. Also, using other groups and gathering places, such as civic groups, fraternal groups, barbershops and hair salons, makes a difference in reaching the community.
-
Overcoming other barriers that impede cancer prevention should also be a priority. Inadequate access to available health care services, competing priorities—including food, shelter, and safety—and basic mistrust of the health care system all contribute to cancer health disparities.
-
At Howard University Cancer Center, efforts are made to establish long-term collaborative, community-based partnerships. Social reinforcement strategies, such as the use of lay health providers, community awareness programs, town meetings, and minority investigator training programs, are central to this goal.
-
The program development model that provides a continuous loop for assessing needs, clarifying goals and objectives, analyzing internal and external obstacles and resources, and using the data gathered during the feedback phase of the cycle to further inform the continuous process of program development has the advantage of involving representatives from community-based organizations and gaining their commitment to the evaluation process.
-
In order to address the lack of minorities in cancer-related professions, it will be important to figure out how to funnel the students coming out of the Historically Black Colleges and Universities that have medical schools, as well as those from the University of Puerto Rico, into the cancer field.
DR. CATHERINE HARVEY
Background
Dr. Harvey currently serves as a Director of the South Carolina Cancer Coalition and Chair of the Board of Directors of the National Coalition for Cancer Survivorship (NCCS). She is a partner in Oncology Associates, a cancer consulting firm that provides a wide range of services to academic medical centers, hospitals, clinical practices, and health care businesses. Previously, she served as Vice President of Clinical Services and Public Policy at OnCare and as Executive Director/Chief Operating Officer of the National Comprehensive Cancer Network (NCCN). Dr. Harvey holds a master’s degree in Nursing from the University of North Carolina and a doctoral degree in Public Health from the University of South Carolina.
Key Points
-
The cancer community has made great strides in increasing the awareness that cancer care in a clinical trial may be the best treatment option. However, advocacy and educational missions are far from complete. Community-based cancer care is the right venue for the treatment of many people, and it is, in fact, where 80 percent of all adult cancer patients are treated today.
-
A patient should not have to forego access to a clinical trial in order to stay close to home. A high-quality cancer clinical trial should, indeed, be the first and best option considered for cancer treatment—not the last resort when all else has failed.
-
In order to optimize the outcomes for all people diagnosed with cancer, all patients being evaluated for cancer treatment should know about clinical trial participation at the initiation of therapy; this would help guarantee the best possible evidence base for the treatment. Ensuring that patients are offered a clinical trial will require a commitment from the public, patients, payers, and providers. Public awareness of clinical trials should be strengthened considerably so that patients will demand trial participation. Advocacy groups can help with that effort.
-
The current regulatory financing and reimbursement system should be examined to expose the multiple layers of bureaucracy and fragmentation that greatly burden and impede participation in clinical research. Specifically, the new Medicare Prescription Drug, Improvement and Modernization Act (Medicare Modernization Act; MMA) and its impact on office-based clinical oncology, as well as the HIPAA regulations, must be scrutinized.
-
The fragmentation and redundancy of the current system of clinical trials review through IRBs should be revised to more efficiently and effectively bring clinical trials to patients. Cancer researchers should be able to concentrate on developing trials and not on the process of getting them approved.
-
Community oncology practices that already have high accrual to clinical trials should be identified and studied to evaluate best practices. Communities that have a Community Clinical Oncology Program (CCOP) grant have already begun to address the communication and bureaucratic issues that inhibit clinical research. In communities where there is less organization and more bureaucracy, accrual is handicapped. There is also a concern with MMA that, as the reimbursement process changes, there may be a loss of participation in NIH trials simply because funding will not allow it.
-
The accreditation and financial incentives for providers and hospitals need to be strengthened by requiring higher levels of participation, which will expedite answers to important clinical questions. Specifically, programs that require participation by hospitals in clinical trials—such as the American College of Surgeons Approvals Program—could be strengthened. However, if that happens, it should be understood that infrastructure must be paid for independently of the funding for any single trial.
-
The collaborations among the NCI, Cooperative Groups, FDA, CMS, academia, the pharmaceutical industry, patient advocacy groups, and others must be examined and revised to maximize participation and involvement in research.
-
Best practices in academic hospital and community practices wherein shared decision-making models result in higher accrual to clinical trials need to be identified. NCCS would like to see more time and resources spent on ensuring that patients are always offered a clinical trial and that aggressive palliative care is valued and considered a viable treatment option along with investigations of new curative agents for cancer.
-
Until providers are expected to uniformly incorporate high-quality cancer clinical trials as the first and best options for their patients, there will not be a significant change in accrual rates.
-
Patients would be much better served if the billing and coding system of reimbursement paid for services patients needed, recognized that research costs money, and was willing to pay for the extra administrative costs and the extra time physicians and research professionals need in order to interact with the patients.
DR. STANTON GERSON
Background
Dr. Gerson is the Director of the Case Comprehensive Cancer Center and the Asa and Patricia Shiverick–Jane Shiverick (Tripp) Professor of Hematological Oncology and Chief of the Division of Hematology/Oncology at University Hospitals of Cleveland and Case Western Reserve University. He is also the Associate Director for Clinical Research at the NCI-designated Case Comprehensive Cancer Center and Founding Director of the Ohio Wright Center for Stem Cell and Regenerative Medicine. Dr. Gerson received his medical degree from Harvard Medical School.
Key Points
-
Cleveland lags behind the nation in terms of its high poverty rate, poor educational system, and poor air quality. However, Cleveland’s community is committed to biomedical enterprise, with its University Hospitals, Case Western Reserve University, and the Cleveland Clinic. The Case Comprehensive Cancer Center brings those entities together, providing care for over 60 percent of the local population.
-
The best cancer care comes from offering clinical trials and clinical research. Education about clinical trials should start at the first office visit, as should prevention education. Also, funding for clinical research conducted by physicians should be encouraged, as should interactions with major medical centers. The cancer community is not doing a good job of evaluating trials, which would greatly help in building trust in the patient community. Patients have no idea which trials are doing well, which ones are not, and which patients are receiving the highest benefits from trials, both specifically and generally. Also, since community oncologists are reimbursed only for drugs that have been approved, they are less able to participate in clinical trials.
-
In order to change the practice of medicine in the community, more physicians should be linked to CCOPs, academic medical centers, and NCI-designated Comprehensive Cancer Centers, either financially or through networks. These networks would provide them with up-to-date information about the results of clinical trials and clinical opportunities. Also, it is an important obligation for national funding for Comprehensive Cancer Centers to engage in outreach programs, not only to the patient population, but to the physician population as well.
-
Better databases linking clinical outcomes and research should be developed. Databases with patient genetics and samples would allow for a seamless intervention and interaction between the databases that are already available—keeping in mind the complexities of HIPAA regulations.
-
Additional funding mechanisms linking component community sites with academic medical centers should be explored. Over 80 percent of patients are cared for in the community; it would be beneficial to link sites together nationally as well as locally.
DR. PAUL SCHAEFER
Background
Dr. Schaefer is Principal Investigator for the Toledo Community Clinical Oncology Program of the National Cancer Institute. He is currently involved in the private practice of medical oncology at the Toledo Clinic. He also serves as Section Head of Oncology/Hematology at the Toledo Hospital; Co-Chairman of the Cancer Committee, Chairman of the Tumor Conference Board, and Clinical Associate Professor at the Medical College of Ohio; and Section Head of Hematology/Oncology at St. Luke’s Hospital. Dr. Schaefer received his medical degree from The Ohio State University College of Medicine.
Key Points
-
It is fairly easy for community oncologists to get information about clinical trials if they desire to do so. Participating in clinical trials, on the other hand, requires considerable time and effort.
-
There are hurdles to getting patients into clinical trials. One is that patients do not know the strength and value of clinical trials, and they are not comfortable with being “guinea pigs,” especially if they have just learned their diagnoses and are fearful about treatment. The way to overcome this is education via the popular media; clinical trials need to be well promoted.
-
It is becoming very expensive to enroll patients in clinical trials, particularly with the new Medicare guidelines separating reimbursement for drugs from administration of those drugs. If it costs community oncologists to put patients on clinical trials, accrual rates will drop considerably, as reimbursement will not cover the cost of doing business. Also, it takes three times as much provider time—time that is not reimbursed—to put a patient on a clinical trial than it does to administer standard therapy.
-
Some insurance companies refuse to enroll patients in clinical trials. This problem should be addressed at the state level.
-
Physicians need to be educated about clinical trials beginning in the first year of medical school.
-
Patient advocates are an essential part of the entire cancer program.
-
The medical oncology community is very up to date on new drugs and therapies and makes an effort to disseminate this information into the community. However, outreach is not universally successful.
DR. K. “VISH” VISWANATH
Background
Dr. Viswanath is an Associate Professor in the Department of Society, Human Development, and Health at the Harvard School of Public Health; an Associate Professor of Medical Oncology at the Center for Community-Based Research at the Dana-Farber Cancer Institute; and Co-Leader of the Health Communication Core of the Dana-Farber/Harvard Cancer Center (DF/HCC). He received his Ph.D. from the University of Minnesota.
Key Points
-
The most effective way to treat cancer is not to get it in the first place. Almost 50 percent of cancers are attributable to lifestyle factors, including smoking and obesity. When talking about translational research, it is important to keep that in mind.
-
Research diffusion and dissemination requires an active, systematic, deliberate, rigorous, and tenacious approach. Researchers should put the same emphasis on systematic rigor for translational research as they do on designing laboratory work and trials.
-
Systems and people vary in their capacity to learn and use information. Different people and different groups access and use information differently. Not everyone has the same access to information, and not everyone has the same ability to use the information they have.
-
Sustainability of interventions is a particular challenge. Researchers must understand scalability of research before embarking on translational research. The certainty of the laboratory evaporates when transferred to the community.
-
The focus of translational research should not be just on translation of research and knowledge into practice, but also on the ways in which the community intersects with systems. Different groups come into contact with different systems, including churches, community organizations, hospitals, unions, and Head Start programs. Researchers should ascertain how people intersect with systems and how to exploit those interactions to reach out to individuals.
-
Translational research should also actively engage community groups and the private sector to accelerate knowledge transfer.
-
There should be incentives for the research community and academic medical centers, including cancer centers, to actively push research dissemination. Pressures, and perhaps even penalties, may also be valuable. Having a coordinator position specifically for diffusion and dissemination and requiring cores in translation may also help institutionalize the process, as well as provide critical incentives and encouragement. Mentoring programs would also help, especially in bringing minority scholars into the system.
DR. STEVEN N. WOLFF
Background
Dr. Wolff is Director of the Clinical Research Education for Career Development program and Principal Investigator of the Minority-Based Community Clinical Oncology Program (MBCCOP) at Meharry Medical College in Nashville, Tennessee. At Meharry, he is a Professor of Medicine, Director of the Sickle Cell Program, and Interim Director of Hematology/Oncology. Dr. Wolff also serves on the Board of Directors and is the Scientific Director of the Lance Armstrong Foundation.
Key Points
-
It is feasible to perform clinical research in underserved and poor communities. A third of the patients at the Meharry MBCCOP have no medical insurance, and another third are covered by Medicaid. However, 15 percent of the patients are involved in clinical trials.
-
There are practical solutions to the challenge of getting patients into clinical research. First, there must be a mandate for the institution to perform clinical research, with each provider having an incentive, either academic or financial, for having clinical research in his or her practice. There must be an institutional philosophy that clinical research is important to the institution.
-
Extra resources are usually required. The Meharry MBCCOP has a U54 grant in partnership with Vanderbilt. This means that there is a shared cadre of personnel and resources to accommodate research.
-
Personnel resources must include culturally sensitive and trustworthy people who can talk to patients and earn their trust, assuring them that being put on a clinical trial is a beneficial step in treatment.
-
Healthier patients are needed. The number of uninsured patients is increasing, along with poverty and the low health levels associated with it. Too many patients are diagnosed at advanced stages of disease with comorbidities that prevent participation in trials.
-
There must be clinical studies that are appropriate to the average patient population. Many study criteria are so strict that average patients do not qualify.
-
There are good reasons that patients do not go on clinical trials. Some are simply too sick to participate, either because their disease is too advanced or because they have more comorbidities than are allowable for clinical trial participation. Also, their performance status, which is a measure of general health, is usually worse than that of other applicants.
-
General mistrust of the medical community by the African-American community can be overcome if studies are presented in a sensitive and trusting way.
BEST MECHANISMS FOR MOVING RESEARCH INTO COMMUNITIES—DISCUSSION
Key Points
-
It is important to strive to establish long-term collaborations between academic sites and their communities.
-
There are many medical providers who do not value clinical trials. This needs to be addressed so that more providers see clinical research as an important part of their mission and that trials are perceived as adding value to their practices and benefit the patients coming to see them.
-
There is a high cost to doing clinical research, and the need for additional funds and support is real, especially in the community setting. There is also need for IRB oversight and data safety monitoring.
-
Providers and researchers should talk to patients and understand their behaviors and lifestyles before recruiting them into clinical trials.
-
Putting patients on clinical trials is a burden, and therefore, there must be rewards for doing so.
-
Focusing on raising public awareness about clinical trials is extremely dangerous if there is not a trial to offer to every person. There are major problems in the system to fix before public awareness campaigns can begin wholeheartedly.
-
A fair amount of evidence has been presented such that, often, the farther one goes away from an academic center and from clinical trials—although the drugs or the treatment might be correct—the greater the likelihood that the dosage and the extent to which therapies are given may not be optimal.
