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PubMed2006

Universal health care: a regional perspective--why not a "Georgia SecureCare"?

Despite conventional wisdom that southern states have neither the money nor popular support for such a program, a Georgia group has outlined a universal, comprehensive, single-payer proposal called "Georgia SecureCare." The group's telephone survey in 2003 found that a majority of households was concerned about losing health insurance or access. Economic analyses demonstrated that SecureCare would reduce statewide health care spending by dollar 0.72 billion (approximately 2%) in the first year while providing all Georgia residents with a generous benefit package. Despite initial increased healthcare utilization costing about dollar 3.84 billion, notable savings were attributable to lower annual administrative costs (dollar 3.82 billion) and bulk purchasing (dollar 0.74 billion saved for prescription drugs and durable medical equipment). For most families and for large employers, annual expenditures for health would decline. Georgia respondents to the telephone survey initially expressed approximately 72% support for SecureCare. After furnishing them with common objections to the plan, their support dropped to approximately 62%. A universal, state-sponsored plan would likely save money for Georgia, and it could easily win broad-based popular support.

Financing, Government↗
PubMed1985

The financial impact of a comprehensive adolescent pregnancy program on a university hospital.

This study investigated the financial impact which an adolescent pregnancy program had on one of its sponsoring agencies, the University Hospital, Salt Lake City, UT. Financial data from hospital billings and collections on the 75 teens who delivered during a 12-month period were reviewed. A comparison of the money for salaries supplied to the special program by the hospital with the amount of estimated "new" money generated for the hospital by the program yielded an income to expenditure ratio greater than two. Eighteen teens who were in the lowest self-pay category were matched to self-pay teens delivering at the same hospital who received traditional prenatal care. The hospital collection rate for teens in the special program was not significantly greater than that of the comparison group. The investment in an adolescent pregnancy program was beneficial mainly from the viewpoint of recruitment of patients who were brought into the hospital system as a result of the adolescent pregnancy program.

Accounting↗
PubMed2003

American Society of Clinical Oncology policy statement: oversight of clinical research.

UNLABELLED: Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public understanding of clinical research oversight. 6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system. This policy statement makes recommendations in several areas that serve as principles to support an improved system of oversight for clinical research. ASCO will work with all parties involved in the clinical research system to develop the steps necessary to implement these recommendations. Centralized Trial Review: A large percentage of oncology clinical trials are coordinated through the National Cancer Institute's (NCI) system of cooperative groups, which already incorporates centralized scientific review. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained IRB members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (CRBs) would also contribute consistency and efficiency to the process. Once successfully completed, the review would represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution. Considering the enormous size and complexity of the clinical research enterprise, ASCO envisions multiple CRBs, which could be distributed as regional review boards. Central review will use a single protocol and consent form, and monitor and evaluate adverse events (AEs) on a global basis, eliminating many of the time-consuming steps for the local IRB. Global monitoring and assessment of AEs has real potential to enhance trial participants' safety by giving local institutions more information on the overall trial and enabling them to devote more time to ongoing review of the trial onsite. Use of a CRB also has real potential to reduce the costs of clinical trial oversight by allowing local IRBs to eliminate the costs of initial review. These efficiencies will likely lead to institutions redirecting funds toward monitoring ongoing trials. Although a CRB has potential to improve the efficiency of the process, a CRB could also have tremendous ability to delay valuable trials. Checks and balances must be included in the newly devised system to ensure timely review and appeals of CRB actions. ASCO proposes the advent of a new pilot program for centralizing review of clinical trials. It requires clear engagement of all stakeholders in planning the experiment, clear articulation of the goals, and assurance of federal regulatory protection for institutions choosing to participate. If successful, this CRB pilot project could be expanded to include multi-institutional industry-sponsored research. Education and Training:Education and training are critical to the ultimate success of an improved oversight system. All members of the research team should receive comprehensive education on conducting scientifically and ethically valid clinical research. The curriculum should also include information on the prevailing local and federal regulations that pertain to the clinical trials process. IRB members should also receive ongoing education and training in the review of clinical research protocols. IRB training should pay particular attention to nonscientific members to give them the tools necessary to speak on behalf of research participants. ASCO should develop a curriculum that focuses on the proper conduct of human research and emphasize ethically sound clinical research in the context of its Annual Meeting. Informed Consent: Investigators and review boards have specific roles to play in ensuring the education of trial participants through the informed consent process, both when they are considering trial enrollment and as they participate in the trial. Review boards and investigators should focus primarily on the informed consent process, rather than the informed consent documents. Federal Oversight: The federal government has an important role to play in the oversight of clinical research. This role should be expanded to cover all research, not just that which is funded by the federal government or conducted with the oversight of the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the FDA should provide clear regulatory support and guidance for local institutions that choose to employ a CRB. In the case of the pilot CRB discussed in this policy statement, it should serve as the preferred option for the cancer cooperative group clinical trials. Ideally, the federal government should unify and streamline its regulations for the oversight of clinical research. Resources Supporting Clinical Research Infrastructure:An effective oversight process demands the highest quality scientific and ethical review and onsite monitoring of the safety of trial participants. This can only be accomplished by the involvement of an experienced IRB that receives funding, resources, and institutional support enabling it to fulfill its mandate. CONFLICT OF INTEREST: Critical to the integrity of research is the absence of bias in the process. ASCO strongly recommends the adoption of standards for the identification, management, and, where appropriate, elimination of conflicts of interests, whether they are actual, potential, or apparent.

Biomedical Research↗
PubMed1996

Community health clinics under managed competition: navigating uncharted waters.

In this article, we consider how major changes in the health care system, both real and proposed, may affect the future of community health clinics (CHCs) in the United States and their ability to continue to provide comprehensive care to underserved populations. We discuss the constraints and opportunities that CHCs face in a health care system that is rapidly moving away from fee-for-service medical care toward a model of managed competition. We describe the role that the National Association of Community Health Centers has played in advocating for CHCs in Congress and the role state primary care associations are playing in spear-heading the development of statewide CHC-sponsored health maintenance organizations. We also analyze CHC reactions to the changes in federal policies that were proposed in the major health care reform bills of the 103d Congress, as well as the prospects for CHCs under Medicaid managed care as it sweeps rapidly across the nation. As a case study, we examine California's policies that mandate that Medicaid recipients enroll in either a private managed care plan or a newly created public plan, which compete against each other within each county. CHCs are vulnerable during the transition to managed care and managed competition, and they have neither the resources nor the ability to integrate or compete successfully with private health maintenance organizations without safeguards, new sources of funding, technical assistance, improved infrastructure, and vigorous monitoring and oversight from federal and state governments, as well as the continued education, training, and policy advocacy provided by the National Association of Community Health Centers and state primary care associations.

California↗
PubMed1992

HMOs for Medicaid: the road to financial independence is often poorly paved.

During the 1980s both the federal government and the private sector articulated policies to encourage the development and participation of health maintenance organizations (HMOs) in the Medicaid program. However, the policies, intended to save costs, limited the ability of new HMOs to achieve financial independence. New plans that emphasize Medicaid participation have few, if any, options on benefit design or in setting capitation rates. Relative to fee-for-service Medicaid programs, their costs to provide services may be quite high, as they have neither the buying power not the ability to impose discounts. As a consequence, plans must focus their financial planning efforts on targeting and attaining a stable enrollment base and on controlling the amount of services provided, tasks that are difficult for all HMOs. Achieving a stable enrollment base is particularly hard because Medicaid eligibles have few incentives to enroll and once enrolled often lose their Medicaid eligibility. Traditional HMOs control the amount of services provided through physician selection, financial incentives on physicians, and monitoring and utilization review. Lack of information and the difficulty inherent in attracting sufficient provider participation limit the first two strategies, so new plans often adopt organization structures that rely heavily on monitoring activities. Unfortunately, management information systems for HMOs are often the weakest link. We discuss the tasks and present data on financial planning, on putting financial plans into operation, and on monitoring progress toward financial independence for a set of ten demonstration projects sponsored by the Robert Wood Johnson Foundation.

Cost Control↗
PubMedDate not supplied

Developing a local public health infrastructure: the Maine Turning Point experience.

This article describes the efforts of public health leaders to develop local public health capacity across Maine. More than 200 individuals representing both government and nongovernmental organizations became engaged in The Robert Wood Johnson Foundation-sponsored Turning Point project in 1999. In recent years, the state has had only two local (city) health departments, only one of substantial capacity covering an extremely small proportion of the total state population. This article describes Maine Turning Point organizational efforts, challenges, successes, and failures, from the perspective of 3 individuals involved in the process. Five years later, a new network of state-financed, community-based partnerships focused on chronic disease risk factors has been established, apparently strong enough politically to survive in an era of severe state budget cuts. Tobacco use has been reduced. Many other serious public health issues, however, from obesity to mental illness and substance abuse, remain to be successfully addressed. The development of a sustainable statewide network of local agencies providing the essential public health services remains an elusive goal.

Community Health Planning↗
PubMed1991

Civilian Health and Medical Program of the Uniform Services (CHAMPUS); annual fiscal year deductible for outpatient services or supplies--DoD. Final rule.

This amendment incorporates the applicable provisions of recent statutes relevant to the deductible amounts for outpatient care. Public laws 101-510 and 101-511 provide that effective April 1, 1991, the deductible amounts for medical care or services will increase from fifty dollars ($50.00) to one hundred and fifty dollars ($150.00) for an individual and from one hundred dollars ($100.00) to three hundred dollars ($300.00) for a family to include all CHAMPUS beneficiaries except dependents of active duty sponsors in pay grades E-4 or below. However, the Persian Gulf Conflict Supplemental Authorization and Personnel Benefit Act of 1991, Public Law 102-25, stipulates that, in the case of dependents of a member of the Uniformed Services who served or serves on active duty in the Persian Gulf theater of operations in connection with Operation Desert Storm, the provisions of Public Laws 101-510 and 101-511, shall not become effective until October 1, 1991. This latter category is defined in the rule as those dependents whose sponsors, are, or were, entitled to Special pay for Hostile Fire/Imminent Danger authorized by section 310 of title 37, United States Code, for service in the Persian Gulf Area.

Ambulatory Care↗
PubMed1995

The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials.

The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and that these approaches be evaluated through clinical trials. To oversee these trials, the National Institute of Allergy and Infectious Diseases (NIAID) has created three large clinical trial programs monitored by a Data and Safety Monitoring Board (DSMB). For each clinical trial, this Board uses a standardized approach employing contemporary biostatistical, medical, and ethical principles. The DSMB is responsible for reviewing interim data on clinical trial performance, treatment safety and efficacy, and overall study progress. If interim results provide convincing evidence of either excessive adverse effects or significant treatment benefit, the DSMB may recommend early termination of the trial to the NIAID and the study investigators. The responsibility, organization, and operating procedures of this DSMB are presented and illustrated through three clinical trials sponsored by NIAID and monitored by the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings.

Advisory Committees↗
PubMed2006

[Evolution of mortality and current status of an HIV-infected population cared for at a comprehensive HIV/AIDS center in Chile].

BACKGROUND: Chile, a middle-income country with an HIV epidemic of moderate proportions (global infection rate 0.2%) began a government sponsored, free, highly active antiretroviral therapy (HAART) for patients from the public health system in 2001 reaching in 2004 a 100% coverage. Arriaran Foundation (AF) is the largest public AIDS care center for adults in the country. AIM: To show the present status of the AF population and the evolution of mortality. MATERIAL AND METHODS: Review of AF database from 1991-2004 that at 12/31/2004 had a total cumulative population of 2,259 adult patients; an active census of 1,065 patients and admitting rate 160-190 patients per years. RESULTS: The global mortality registered was 33.4%, with decreasing annual mortality from 15.7% of its active population in 1995 to 1.9% in 2004. As of 12/31/2004, 817 patients (76.7%) were receiving antiretroviral therapy (ART); and 19.3% either did not require nor accept it. Thirty one percent received Combivir and nevirapine, with undetectable viral load (<400 copies per ml) in 78%. Thirty percent received Combivir and efavirenz with undetectable viral load in 80% at last count. Both regimens were used mainly as first therapy. Lopinavir/ritonavir was received by 6.3% of patients, mainly for post failure therapy and 58% had undetectable viral load. A baseline CD4 count <200 x mm(3) was present in 70% of patients, 45.3% had a count below 100 and 47.8% had clinical AIDS. At the last follow up assessment, CD4 count was <200 in 36.8%, <100 in 10.6% and 200-350 in 44.9%. CONCLUSION: The expanded access program to ART in a public, comprehensive AIDS care center in Chile has been highly successful in reaching high undetectability (75%), reducing mortality and improving immune status despite very advanced baseline disease.

Acquired Immunodeficiency Syndrome↗
PubMed1993

Managing the health care system under a global expenditure limit: a workshop summary.

There is ongoing debate as to whether global budgets, or expenditure limits, are compatible with a strategy for managed competition. The Robert Wood Johnson Foundation sponsored an invitational conference for public and private policymakers to discuss the issue. The meeting's purpose was to explore how global expenditure limits might work and what their implications would be for costs, access, and quality of health care. This article summarizes the ideas presented at the conference, looking in particular at global expenditure limit models in Germany and Canada. Overall, the papers and presentations at this meeting demonstrated that global expenditure limits have the potential to provide the necessary fiscal discipline to manage the health care system and provide a greater degree of certainty and accountability for payers, providers, and patients. However, it is also clear that without a common set of principles about the role health care should play in our society and an agreed upon framework of governance for the system, it will be difficult for the United States to resolve the detailed and complex implementation and administration issues of a reformed health care system.

Budgets↗
PubMedDate not supplied

PVO / NGO initiatives, Latin America. Grupo pela VIDDA, Brazil.

"VIDDA" is a Portuguese acronym representing enhancement, integration, and dignity of people living with HIV/AIDS (PWAs). The groups are composed of people infected with HIV, their friends, relatives, lovers, and anyone who feels that his or her everyday life has been affected by the epidemic. They hope that through solidarity they can respond to the difficult situation facing people who are HIV positive in Brazil. Grupo pela VIDDA seeks to raise the consciousness of the government and the society and force them to take responsibility for the epidemic. Their fundamental objective is to fight for PWAs to have a full range of civil rights. "This is a fight that we have in common with all the Brazilian people who are searching for democracy, the right to work, and access to good health services," states a Grupo pela VIDDA brochure. Through their network they provide accurate and current information, counseling, legal assistance, and sponsor support groups. For more information, please contact Grupo pela VIDDA, Rua General Jardim, 556 CEP 01223-010, Cx Postal 54063, CEP 01296, Sao Paulo SP, tel/fax: +55 11 258 7729; or Rua 7 de Setembro, 48 12 andar CEP 20050-000, tel: +55 21 224 1654, fax: +55 21 294 5602. There are also offices in Curitiba, Goiania, Niteroi, Recife, and Vitoria.

Ambulatory Care Facilities↗
PubMed1998

Oncology services: the Department of Defense perspective.

The Department of Defense (DoD) military health system has responsibility for providing medical care for more than 8 million beneficiaries. This article discusses initiatives related to both the providing and purchasing of oncology services. A description of health care coverage under TRICARE, the Department's managed care program, which utilizes military treatment facilities and civilian health care providers, is provided. Participation in clinical trials by the DoD beneficiaries, oncology services in military treatment facilities, quality management programs, cancer research, and the development of new technologies to enhance early cancer detection are presented. Access to research trials and new technologies is necessary for a comprehensive approach to cancer care. Clinical trials have been the vehicle by which the oncology community developed most of its formal clinical evidence for the efficacy of various treatment approaches. The Department participates in clinical trials through cooperative group membership or affiliation. Through an interagency agreement with the National Cancer Institute, DoD beneficiaries have available the option of participating in NCI-sponsored clinical trials through the direct military care system or through civilian care with reimbursement for approved protocols nationwide. The DoD has been actively involved in breast cancer research since 1992 and prostate and ovarian cancer research since 1997. The goals of the cancer research programs are to expedite and facilitate breakthroughs in research, support innovative, and exploratory ideas with a vision to foster new directions, address neglected issues, and bring new investigators into the research arena. The program incorporates the consumer perspective by involving consumers in the decision-making process. The DoD health care system trains experts in the management of cancer patients and provides a multidisciplinary approach to care through the direct military health care system or through network providers as part of the TRICARE system. Although cost containment is key, the delivery of high quality health care that is easily accessible is a primary goal of the military health system. Provision of a comprehensive benefits package that includes a spectrum of care and employing outcomes measurements to evaluate care that is appropriate for the patient's disease is essential.

Clinical Trials as Topic↗
PubMed1975

The health maintenance organization delivery system. A national study of attitudes of HMO project directors on HMO issues.

A national survey of health maintenance organization project directors' attitudes on HMO delivery issues was conducted to gather data about HMO planning development and delivery areas. Questionnaire results revealed characteristics of the HMO project director, sponsoring institution, and developmental stage. Seven HMO issues (Prepayment Mechanism, Quality of Care, Degree of Federal Participation) Public and Private Funding, Physicians' Attitudes toward HMO, and Consumer Recruitment) were identified to measure the attitudes of directors. As a whole, responses were in the positive range. Scale 1 (Prepayment Mechanism) and Scale 2 (Quality of Care) received the lowest mean scores and were in the moderate agreement range. Scale 3 (Degree of Federal Regulation) and Scale 5 (Public and Private Funding) had the highest mean scores and fell between slight agreement and disagreement. Further research has been noted in various administrative features and issue areas of HMO. Most crucial is the outcome of HMO legislation which has a bearing on the policy and program of the HMO delivery system. On the basis of what appears to be a representative sample of directors of DHEW-funded HMO Planning and Development Projects, the study has assessed attitudes on important issues relevant to HMOs and determined areas of greatest agreement and disagreement.

Administrative Personnel↗
PubMedDate not supplied

Case study of the integration of a local health department and a community health center.

As rural communities struggle to sustain health services locally, innovative alternatives to traditional programs are being developed. A significant adaptation is the rural health network or alliance that links local health departments and community health centers. The authors describe how a rural local health department and community health center, the core organizations in publicly sponsored primary care, came to share a building and administrative and service activities. Both the details of this alliance and its development are examined. The case history reveals that circumstance and State involvement were the catalysts for service integration, more so than the need for or the benefits of the arrangement. The closure of a county-owned hospital created a situation in which State officials were able to broker a cooperative agreement between the two agencies. This case study suggests two hypotheses: that need for integrated services alone may not be sufficient to catalyze the development of primary care alliances and that strong policy support may override any local and internal resistance to integration.

Community Health Centers↗
PubMed2005

Effects of a national health education program on the medication knowledge of the public in Taiwan.

BACKGROUND: The inappropriate use of medication and inadequate medication knowledge among the general population has long been a concern in Taiwan. One reason for the deficiencies might be the lack of an active role of pharmacists in educating the public. To rectify the situation, in 2002, the Bureau of Pharmaceutical Affairs, Department of Health of Taiwan, began to sponsor a national effort, titled Community Education Program on Medication Use, to involve the expertise of pharmacists in public education. OBJECTIVE: To evaluate the effects of this education program by analyzing the changes in knowledge of drug therapy among the participating public. METHODS: This was a single-group pre- and post-comparison study. Between September 2003 and January 2004, a total of 955 community residents enrolled in the pharmacist-facilitated education program offered at 31 community universities. The medication knowledge of the participants was evaluated before and after the program. Demographic variables that might affect the education outcomes of the program were also examined. RESULTS: Medication knowledge at baseline was positively correlated with education level and negatively correlated with age. Females were more aware of drug-related information than were males. The participants showed a significant improvement in medication knowledge (p < 0.001) at the end of the program. The baseline knowledge score was the most important determinant of the improvement of the posttest score. CONCLUSIONS: A national education program facilitated by pharmacists can improve the medication knowledge of the participants. Pharmacists should be encouraged to play a proactive role in large-scale health education programs.

Adolescent↗
PubMed2003

Standard reference material for Her2 testing: report of a National Institute of Standards and Technology-sponsored Consensus Workshop.

A workshop was sponsored by the National Institute of Standards and Technology, the Cancer Diagnosis Program of the National Cancer Institute, the Food and Drug Administration, and the College of American Pathologists to address the need for a reference material for Her2 gene protein testing. It was agreed that such a standard was desirable and necessary to ensure the reliability of Her2 testing to qualify patients for trastuzumab therapy. Two standards consisting of well characterized cell lines will be produced, 1 that will be a National Institute of Standards and Technology-certifiable standard, and 1 that will be a commercially developed standard for use in all Her2 testing. It was also agreed that all Her2 testing must be performed on samples fixed only in 10% buffered formalin, as specified in the Food and Drug Administration-approved testing methods. Participants agreed to plan strategies to educate pathologists, clinicians, and laboratories about the need and use of such a standard. A National Committee for Clinical Laboratory Standards guideline for the use of the standard reference material will be created to facilitate this process.

Cell Line, Tumor↗
PubMed2006

Insuring the uninsured: A student-run initiative to improve access to care in an urban community.

CONTEXT: There are 44 million uninsured Americans. Lack of insurance creates a major barrier for the poor and near poor to get adequate medical attention. A portion of these are eligible for insurance and either do not know they are eligible or have difficulty navigating the application process. OBJECTIVE: To evaluate the success of University at Buffalo medical students at a free clinic in helping patients enroll in government-sponsored insurance plans. DESIGN: Observational study SETTING: The Lighthouse Free Medical Clinic--a student-run free clinic operating in an urban minority Buffalo, NY neighborhood. PATIENTS: Five-hundred-seventy-nine inner-city, low-socioeconomic-status patients age <65. INTERVENTION: All patients are screened, and those eligible are encouraged and assisted in completing insurance applications. OUTCOME MEASURES: Primary outcome is the percentage of patients who completed the application process. RESULTS: Five-hundred-seventy-nine patients were seen from October 2003 through October 2004; 319 (55%) were uninsured. Fifty-nine (26%) of those uninsured were found to be eligible for insurance. Fifty-seven applications were initiated, and 23 (40%) were completed and accepted. CONCLUSIONS: There are a significant number of people using the free clinic who are eligible for insurance. The number-one reason adults were ineligible was household income exceeding the state limit. Success of this project provides support for the use of medical student volunteers to assist in insurance application completion in community settings.

Adult↗
PubMed1993

Impact of clinical trial protocols on patient care systems at the University of Texas M.D. Anderson Cancer Center.

Clinical trial protocols represent a significant component of the research program at the University of Texas M.D. Anderson Cancer Center. Currently, there are nearly 800 active protocols using more than 150 investigational drugs. Sponsors of these trials include the National Cancer Institute, numerous pharmaceutical companies, and a variety of other funding sources. Because of our large patient base, however, routine participation in cooperative groups is limited. The impact of clinical trial protocols on patient care systems is a growing concern that is addressed primarily by the Surveillance Committee at M.D. Anderson. Like many institutional review boards, this committee reviews all protocols and must grant approval before the activation of any clinical trial. The issues of medical ethics, including a risk-benefit assessment for research subjects, equitable patient selection, safeguards for economically disadvantaged populations, and the general requirements for informed consent, also fall under the purview of this board. For any comprehensive cancer center to succeed, it must have strong research programs that enhance treatment options for patients. The crisis in financing health care significantly threatens the viability of cancer research. Reimbursement for the related costs of individuals participating in clinical trials has become a battle ground for third-party payers. The resulting economic risk is shared by health care providers and patients. As a consequence, many cancer centers, including M.D. Anderson, have initiated an economic-impact analysis for protocols as a component of the review process. This analysis includes an estimation of the patient care costs compared to the funding allocated to support the research. Future research will include pharmacoeconomic analysis and other ways to relate the costs and outcomes of treatment protocols. In the interim, we must monitor reimbursement trends for patients enrolled in clinical trials closely and amend the informed consent process to include a discussion of potential economic risk or hardship to patients if insurance claims are denied. Cancer care providers, third-party payers, the federal government, and society at large must work together to address the funding of cancer research and patient care.

Cancer Care Facilities↗