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© 2001 American Society for Clinical Oncology
Clinical Trials: Are They a Good Buy?ByFrom the Chicago Veterans Affairs Healthcare System/Lakeside Division; Robert H. Lurie Comprehensive Cancer Center; Division of Hematology/Oncology, Department of Medicine; and Institute for Health Services Research and Policy Studies, Northwestern University, Chicago, IL; Coalition of National Cancer Cooperative Groups, Philadelphia, PA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; and US Oncology, Inc, Houston, TX. Address reprint requests to Charles L. Bennett, MD, PhD, Department of Veterans Affairs, Chicago Health Care System/Lakeside Division, 400 East Ontario St, Medical Sciences Research Bldg, Rm 205, Chicago, IL 60611; email: cbenne{at}northwestern.edu
PURPOSE: Concern that clinical trials may be too costly has been used to justify traditionally restrictive insurer policies regarding clinical trials. Additionally, fear of insurer reimbursement denial can be a significant barrier to clinical trial participation. In this study, we reviewed the empirical data on costs of clinical trials versus standard care and summarized the current status of policy initiatives related to clinical trial insurance reimbursement. METHODS: Electronic and print data sources were searched for studies on the costs of oncology clinical trials. Information on policy initiatives for clinical trial reimbursement was obtained from the American Society of Clinical Oncology, the American Society of Hematology, and the Coalition of National Cancer Cooperative Groups and from searches of World Wide Web sites. RESULTS: Five pilot studies provided information for 377 patients on phase II/III clinical trials matched with controls on standard care. Cost estimates ranged from 10% lower to 23% higher costs/charges for clinical trials in comparison to standard medical care. Medicare, 14 states, and several private insurers now cover the costs of patient care in "qualifying" clinical trials. CONCLUSION: Findings from small pilot studies suggest that phase II and III clinical trials result in at most modest increases in cost over standard treatment costs. Also, an increasing number of policy makers have decided to support clinical trial reimbursement initiatives. It is hoped that economic data from large observational studies will facilitate widespread and permanent decisions that support reimbursement for phase I, II, and III clinical trial participation.
IT IS ESTIMATED THAT fewer than 5% of adult cancer patients participate in clinical trials.1 In a recent Harris Interactive survey of 5,980 cancer patients, 60% of patients who were aware of clinical trials (14% of survey sample) and elected not to participate (71% of aware patients) cited concerns about insurance denial as a primary barrier to participation.2 However, a United States General Accounting Office report found that many insurers already pay for many patients who participate in clinical trials, despite policies excluding payment for "experimental" therapies.3 As policy makers have become aware that patient concerns over potential reimbursement denial may be a barrier to clinical trial accrual, legislators and insurers have begun to address clinical trial reimbursement policies. The Medicare Cancer Clinical Trial Coverage Act of 1997 sought to authorize a $750 million demonstration project which would reimburse routine patient care costs alongside approved clinical trials. The act also commissioned a report on the actual costs of the funded clinical trials. This legislation was not passed, primarily because of concerns over actual study costs. In 2000, the Institute of Medicine released its report, "Extending Medicare Reimbursement in Clinical Trials," which recommended that the Health Care Financing Administration (HCFA), the former administrator of the Medicare program, reimburse "routine care for patients in clinical trials in the same way it reimburses for routine care for patients not in clinical trials."1 The report projected that the financial impact of clinical trial reimbursement would be small, based on the findings of pilot studies in 1998 and 1999 from the Group Health Cooperative of Puget Sound, the Mayo Clinic, and Kaiser Permanente.4-6 Nonetheless, as health care costs rise, the questions related to reimbursement for clinical trials become increasingly relevant. After the favorable reports on the cost of clinical trials from pilot studies, federal policy makers, private insurers, and several state legislatures have introduced policies or laws that support reimbursement of routine medical care in clinical trials. In this article, we address the current status of reimbursement for clinical trials by reviewing the methodologies, results, and future plans for studies on the costs of clinical trials and reviewing the content of federal, state, and private sector clinical trial reimbursement initiatives.
MEDLINE, EMBASE, HEALTHSTAR, and abstracts from the Proceedings of the American Society of Clinical Oncology from the years 1995 to 2001 were searched for reports on costs of clinical trials. Key words included cancer costs, clinical trial costs, and clinical trial participation. Leaders at the Department of Public Policy of the American Society of Clinical Oncology, the Committee on Practice of the American Society of Hematology, the Coalition of National Cancer Cooperative Groups, the Department of Defense, and the National Cancer Institute were also queried about ongoing policy initiatives related to clinical trial reimbursement. Individual bills pertaining to mandated insurance reimbursement of clinical trials were found through searches of the legislative history on the Web site of the respective legislative bodies. Web sites of health care insurers and managed care organizations operating on a national basis were reviewed to identify programs that voluntarily reimbursed medical care costs incurred on clinical trials. This article addresses routine care costs in clinical trials. For most of the research articles and legislative bills, routine care costs (often referred to as patient care costs in legislation) include conventional care, items or services that are typically provided absent a clinical trial; administrative items, items or services required solely for the provision of the investigational item or service (such as the administration of a noncovered chemotherapeutic agent) and for clinically appropriate monitoring related to complications and treatment effects; and reasonable and necessary care, items or services arising from the provision of an investigational item or service, including the diagnosis or treatment of complications. Routine patient care costs do not include items and services that are customarily provided by the research sponsors free of charge for individuals participating in the trial (such as investigational drugs or items); tests or measurements conducted primarily for the purpose of the clinical trial involved; or the administrative costs associated with collecting research data.
Pilot Studies on Costs and Charges of Clinical Trials Three published studies4,5,7 and two preliminary reports6,8 conducted an economic evaluation of the routine medical care costs of clinical trials. These studies included information on patients enrolled onto phase II (one study), phase III (one study), and phase II and III clinical trials (three studies). (Table 1) A total of 377 patients on clinical trials were included in the five studies (range, 35 to 165 patients per study). Three studies included information on patients treated in the mid-1990s, one study covered the years 1988 to 1994, and one covered the years 1990 to 1996. Two studies were for patients who received care at managed care organizations (Kaiser Permanente and Group Health Cooperative), two were single-site studies from tertiary cancer centers (Memorial Sloan-Kettering Cancer Center and the Mayo Clinic Cancer Center), and one was from five tertiary cancer centers that belong to the Association of American Cancer Institutes (AACI). Control groups included patients with the same diagnosis and tumor stage and similar comorbidity levels who received similar treatments in the setting of standard cancer care.
The studies found that the differences in costs (four studies) or charges (one study) ranged from a 10% savings to a 23% increment for clinical trial participation at 6 months of follow-up, a 10% to 14% increment at 12 months’ follow-up, a 20% increment at 24 months, and a 1% increment at 60 months’ follow-up (Table 1). There was a wide variation in costs/charges for individual patients and controls, with some clinical trial patients differing by more than $200,000 in costs/charges from matched controls. For breast cancer patients who underwent autologous stem-cell transplantation, mean costs were 120% greater than costs for controls who received standard chemotherapy, while charge estimates were 15% lower in comparison to charge estimates for controls who received autologous stem-cell transplantation outside of a clinical trial. In evaluating the findings of these studies, several methodologic considerations related to selection of cases and controls, identification of resources, estimation of costs, and statistical analyses should be discussed (Table 2). These areas represent the most important features of economic analyses of cancer care.9-11
The studies included patients with between two and nine different types of cancer diagnoses, with breast cancer being the most common diagnosis. Two studies identified cases by reviewing logs from cancer registries at the managed care organization, two studies identified patients through searches of electronic and paper files, and one study included a random sample of a specified number of clinical trial participants at each of five tertiary cancer centers. In some cases, the same patient participated in more than one clinical trial during the study period. The AACI/Northwestern University and the Memorial Sloan-Kettering Cancer Center studies included only those patients who received the majority of their care at the participating cancer center because of the operational difficulties associated with cost identification for medical care provided in multiple settings. Identification of appropriate controls was the most challenging aspect of study design. Controls were matched for diagnosis, stage, and age in all five studies. Matching was based on eligibility for the clinical trial in two studies, on survival in one study, and on performance status or comorbidity in two studies. However, the type of comparative treatment varied and in all cases differed from that used for case patients who participated in the clinical trials. For example, three studies included breast cancer patients who received an autologous stem-cell transplant, but two of these identified controls who received standard-dose chemotherapy and one included controls who underwent transplantation outside of the clinical trial setting. For the four published studies, control patients who had similar clinical and demographic characteristics but differed with respect to the specific treatment regimen could be identified for two thirds to three quarters of the clinical trial patients. Measurement of the resources to be included in the economic analyses varied. These data were obtained from electronic claims files in all studies, which facilitated data collection efforts. In the Kaiser Permanente and Group Health Cooperative studies, almost all of the resources associated with cancer care were captured in the electronic data files. The Mayo Clinic study excluded outpatient prescription drugs, durable medical equipment, ambulance and other transportation services, outpatient services provided by allied health professionals, and nursing home care. The other two studies excluded resource use that occurred outside of the tertiary cancer center. The methodology for deriving economic inputs was unique to each study. The Mayo Clinic study assigned a value for each unit of service that was adjusted to national cost norms using Medicare fee-schedule rates for physician and outpatient ancillary services. Hospital charges were converted to costs by applying department-level cost-to-charge ratios obtained from Medicare reports. Unit costs were normalized to national 1995 values by use of regional hospital market-basket indexes obtained from annual Prospective Payment Assessment Commission reports. The Kaiser Permanente study used a proprietary system that assigned a value to each unit of pharmacy, laboratory, imaging, and home health services, with additional allocation of building and administrative overhead rates that were specific to the Kaiser system. Unit costs reflected average annual costs throughout Kaiser Permanente in Northern California. For out-of-network services, provider charges were used as the estimate for costs. Copayments by patients, representing out-of-pocket costs to patients, were also included. Costs in the Memorial Sloan-Kettering Cancer Center study included hospital costs and physician charges, based on estimates derived from Medicare cost-to-charge ratios for the relevant resources. The Group Health Cooperative Study is currently revising its cost estimation effort. The AACI/Northwestern University pilot study used charges, not costs, in the analyses, primarily because the five-site study would have required a different cost estimation effort for data from each tertiary cancer center. In most cases, the preferred method for economic analyses is based on estimates of costs, not charges, because of marked discrepancies that exist between billed charges and opportunity costs in health care.12 These differences vary by type of resource, among physicians, and over time, resulting in a distorted estimate of economic differences between groups of patients treated with a variety of medical resources. Analytic approaches also differed. The Mayo Clinic reported costs over a 5-year time period, the Group Health Cooperative reported costs over a 2-year time period, the Kaiser Permanente study reported on costs over a 1-year time period, and the Memorial Sloan-Kettering Cancer Center and the AACI/Northwestern University studies reported costs over a 6-month time period. Censoring of patients with incomplete follow-up was done only in the Mayo Clinic study because of the long follow-up period. Statistical differences were determined using paired t tests based on matched samples in the studies from the Mayo Clinic and the AACI/Northwestern University, a one-covariate (Charlson comorbidity score) ordinary least squares regression model in the Kaiser Permanente study, and unpaired t tests in the Memorial Sloan-Kettering Cancer Center study. There are two ongoing large-scale efforts designed to develop valid and reliable estimates of the incremental costs of clinical trials carried out in diverse academic and community settings. The RAND/National Cancer Institute (NCI) Costs of Clinical Trials Study is evaluating the costs of 750 individuals enrolled onto phase II/III clinical trials from multiple community and tertiary cancer centers and 750 matched controls.10 The AACI/Northwestern University Clinical Trials Costs and Charges Project has proposed a complementary study that will evaluate and compare the costs of 100 patients enrolled onto phase I clinical trials conducted at tertiary cancer centers with those of an equal number of matched controls. These studies are warranted for several reasons. First, the five pilot studies had sample sizes that were insufficient to detect cost differences that may be important for policy purposes. Second, treatment patterns differ across institutions, and four of these studies were conducted within a single institution or health system, which makes it difficult to generalize. Third, cases and controls matched at a single institution may differ in unobserved but important ways that affect treatment costs, as a result of self-selection into trials. Fourth, the pilot studies excluded some potential important dimensions of treatment, such as clinicians outside the delivery system. Finally, single-institution studies may underestimate the financial impact of transferring care from a community setting in order to participate in some clinical trials.10
Federal, State, and Private Sector Policy Initiatives Related to Reimbursement of Clinical Trials
Medicare policies were not supportive of clinical trials during the 1990s.13 The HCFA excluded coverage of routine care costs associated with clinical trial participation for Medicare enrollees, on the basis that the treatment was experimental or investigational.1 However, the United States General Accounting Office found that less than 4% of claims for clinical trial costs incurred by Medicare beneficiaries were denied.3 Furthermore, they found that oncologists frequently submitted bills for components of complex treatments, without specifying the procedure itself. HCFA is estimated to have paid 50% to 90% of routine patient care costs in clinical trials, after taking into account both costs for which no reimbursement was sought and claims that were submitted and rejected. In 1993, the Office of the Inspector General of the Department of Health and Human Services found that Medicare was being billed millions of dollars for surgical procedures involving unapproved medical devices. Almost all of the 130 hospitals under investigation had billed for clinical trials. However, quickly passed legislation prevented HCFA from collecting from the hospitals.1 In addition, no federal clinical trials legislation has been passed. One 1993 bill, the Cancer Treatment Improvement Act, addressed the issue of clinical trial coverage but never made it past committee. In 1996, the Medicare Cancer Clinical Trial Coverage Act was introduced in the Senate and the Medicare Cancer Clinical Trial Demonstration Act in the House. The bill, which applied to the 44 million individuals whose coverage was regulated by Employee Retirement Security Act plans, would allocate $750 million to cover cancer clinical trials sponsored by the National Institutes of Health (NIH), DOD, and the DVA, would require development of federal regulations that would define routine patient care costs, and would study the impact of clinical trials reimbursement on group health insurance plans. The Medicare Cancer Clinical Trial Coverage Act was reintroduced in 1997, 1998, and 1999, without success. The Health Insurance Bill of Rights Act of 1997 introduced mandated coverage by all group health plans of federally funded clinical trials for "seriously ill patients with no standard treatment alternative." The language regarding clinical trials was folded verbatim in 1998 into the Patient Bill of Rights Act. The Sydney E. Salmon Access to Cancer Clinical Trials Act of 1999 was among the 90% of bills that never make it past committee. The Bipartisan Consensus Managed Care Improvement Act, introduced by Representatives Charlie Norwood (R-Georgia) and John Dingell (D-Michigan) in 1999, was passed by the House in 2000 but tabled by the Senate. The bill would have mandated group health plan coverage of all phases of federally funded prevention, early detection, and treatment trials for patients with serious or life-threatening illnesses. In 2000, after years of lobbying of HCFA leadership by individuals, patient groups, health care workers, and organizations who were concerned about reimbursement denials of clinical trial costs and the low rates of accrual to clinical trials, former President Clinton issued a memorandum stating that HCFA was authorized to cover the costs of cancer clinical trials. This decision was supported by the empirical evidence on the cost of clinical trials from the Group Health, Kaiser, and Mayo Clinic studies, the Institute of Medicine’s report recommending Medicare coverage of routine patient costs on clinical trials, and the growing body of state legislation and voluntary initiatives from private insurers. This benefit included a broad definition of "qualified" clinical trials. The Final National Coverage Determination issued by HCFA extended the definition of qualified clinical trials beyond those funded or conducted by government bodies to trials that satisfied qualifying criteria. Certain trials were deemed to be qualified and automatically covered: those funded by the NIH, the Centers for Disease Control and Prevention, the Agency for Health Research and Quality, HCFA, the DOD, and the DVA; trials supported by centers or cooperative groups that are funded by these organizations; and trials conducted under an investigational new drug (IND) application reviewed by the Food and Drug Administration. The Agency for Healthcare Research and Quality has, in conjunction with other federal agencies and input from interested specialty groups and other stakeholders, developed additional criteria to identify high-quality trials that would be qualified. These criteria await approval from the new administrator of the Center for Medicare and Medicaid Services (formerly the HCFA). Until these qualifying criteria are available, trials that are exempt from having an IND will be automatically considered to be qualified trials if the study evaluates an already defined Medicare benefit, is designed with a therapeutic intent (not to evaluate toxicity), and enrolls beneficiaries with a diagnosed disease if the study is for a therapeutic intervention (but it may enroll healthy beneficiaries if the trial is for a diagnostic intervention). Medicare will cover reasonable and necessary care required to diagnose and treat complications arising from participation in clinical trials, as well as items and services required for the provision of the investigational item. All clinical trials submitted for Medicare coverage will be entered onto a national registry. Medicare will cover all routine costs of automatically qualifying and investigator-certified trials. However, if the Center’s chief clinical officer subsequently finds that a clinical trial was misrepresented, the provider may be held liable for the costs. Efforts to pass broad clinical trial legislation have moved forward in 2001 (Table 4). The recently approved Patient Protection Act legislation led by Senators McCain (R-Arizona), Edwards (D- North Carolina), and Kennedy (D-Massachusetts) in the Senate (S. 1052) and Congressman Ganske (R-Iowa), Dingell (D-Michigan), and Norwood (R-Georgia) in the House (H.R. 2563) includes a section mandating coverage of all phases of federally funded treatment trials for the seriously ill. However, after incorporation of an amendment related to financial and administrative considerations for lawsuits by Representative Norwood (House Amendment 303) that was negotiated with President Bush, the Senate and House bills differ markedly in their language regarding other aspects of managed care and will need to be reconciled in the conference process of the Congress. A bill dealing specifically with coverage of patient care costs of cancer clinical trials was introduced in the House by Representative Deborah Pryce (R-Ohio) as the Access to Cancer Clinical Trials Act of 2001 (H.R. 967). This bill is in line with the Medicare National Coverage Decision and mandates coverage of all phases of federally funded cancer prevention, diagnostic, and treatment trials, trials approved and funded by "qualified nongovernmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants," and IND-exempt investigator-initiated trials. During debate over the McCain-Kennedy-Edwards legislation, the Senate approved a nonbinding "Sense of the Senate" amendment on clinical trials by an 89 to 1 vote. The amendment, offered by Senator McCain, expresses the sense of the Senate that individuals with life-threatening diseases should have the opportunity to participate in federally approved or funded clinical trials. All versions of the proposed legislations state that qualified individuals have life-threatening or serious illnesses "for which no standard treatment is effective" and that participation in the trial offers "meaningful potential for significant clinical benefit." This language raises concern that patients might be excluded from clinical trials if the standard therapies are a reasonable option. Attempts to clarify this language are ongoing. President Bush has also voiced support for coverage of patient care costs for treatment in qualified clinical trials in a February 2001 statement sent to Congress related to "principles" for a patient’s bill of rights. Thus, the prospects for passage of comprehensive federal legislation supporting clinical trial reimbursement are good, although the exact details remain uncertain.
State legislative efforts. As of August 2001, 14 states have passed laws mandating coverage of patient care costs associated with treatment provided on specified categories of cancer clinical trials (Table 5). The question put before state legislatures has been whether the insurance barrier to clinical research is best removed through the voluntary action of health insurers or if formal legislation is needed. Rhode Island was the first state to legislate insurance coverage for clinical trials in 1995. The bill originally supported coverage of phase III and IV cancer treatment trials but was amended in 1997 to cover phase II, prevention, screening, and phase III trials. Qualifying trials were those that were funded by the NIH, DVA, or DOD or conducted in an NCI-affiliated cancer center. Georgia mandated insurance for selected pediatric cancer trials in 1998. Maryland and Virginia expanded on the idea in 1999, mandating insurance for cancer trials conducted in in-state academic institutions. Also in 1999, Maine passed a law requiring coverage of NIH-sponsored trials in cooperative groups or NCI-designated cancer centers. The same year, Louisiana passed a law including these trials as well as trials sponsored by the Food and Drug Administration, DOD, DVA, and the Coalition of National Cancer Cooperative Groups. Several other states followed suit in 2000 and 2001. Illinois extended its guarantee of coverage to all "seriously ill patients for which no standard therapy is available." This ambiguous clause defined the qualified patient as necessarily lacking "standard care," phrasing echoed in the Patient Bill of Rights. Furthermore, it only required that insurers had to offer this as an option, not that employers had to buy the benefit as part of their employee health coverage package. Most of the state-level legislation does not define a qualified patient but instead defines qualified trials. Similar legislation is pending in a number of other states. Many of the current coverage initiatives exclude phase I trials partly because no data exist on costs, little data exist on the investigative treatment, and the treatments have little chance of being therapeutic. Other initiatives limit their scope to trials with a therapeutic intent. Most initiatives limit coverage to cancer clinical trials, in part because the national infrastructure surrounding cancer trials is the most established and comprehensive of all diseases and cancer clinical trials are subject to high levels of controls, monitoring, and oversight. State legislative efforts do not pertain to employees of self-insured corporations as defined under the Employee Retirement Security Act of 1974. Lastly, concern over variable scientific quality has led many state legislatures to limit reimbursement to trials funded by federal agencies. Although institutional review boards ensure that a trial is designed and conducted ethically, they do not assess scientific validity. However, this policy excludes a great many high-quality clinical trials that are funded by sources other than the federal government.
Private insurer efforts. Private insurers may be concerned that clinical trial costs are excessive, primarily as a result of extensive observation and testing periods. Uncertainty over reimbursement, rather than actual denial of reimbursement, may adversely affect participation in clinical trials. Furthermore, some clinical trials, such as trials of bone marrow transplantation for breast cancer, were undoubtedly expensive. In the early 1990s, private insurers who refused reimbursement for bone marrow transplants for breast cancer paid large jury awards and settlements to families of the affected individuals. Subsequently, many states and private insurers adopted policies to reimburse for the procedure. In 1999, findings of an absence of clinical benefit with bone marrow transplantation for breast cancer were reported. The reports had been delayed by several years because poor clinical trial accrual had led to an extended study period. At the end of the prior decade, several large private health insurers agreed to reimburse for medical care that occurs with clinical trials. These insurers included the New Jersey Association of Health Plans, OhioMed, United Healthcare, and the Mayo Health Plan14 (Table 6). The New Jersey Association of Health Plans agreement is unique in that it represents the first instance for which all private insurers in a single state have voluntarily agreed to provide cancer clinical trial coverage. The agreement was the result of a collaborative effort of a working group consisting of insurers, consumers, and physicians. In the face of recent expansion in state legislation on health insurance, Michigan and Minnesota have recently followed the New Jersey example by encouraging collaborative task forces to work with private insurers to voluntarily pursue clinical trial coverage. Policy makers in Minnesota felt that a voluntary agreement among insurers avoided the antagonistic nature of mandated health coverage and would more likely lead to a broader definition of qualified clinical trials than piecemeal legislation. Voluntary initiatives might also foster cooperation. However, the task force from New Jersey also warned that oversight of the insurance agencies was still warranted.
A paradox exists in reimbursement policies in which insurers may refuse to cover a promising new therapy because it is available only through clinical trials while covering what is considered standard treatment even though it may often be ineffective and sometimes more expensive. Pilot studies have found that the incremental costs and charges of clinical trial participants are similar or only slightly greater than those incurred by patients not enrolled onto clinical trials. It is expected that the large RAND/NCI Costs of Clinical Trials Study, which addresses phase II and phase III studies, the AACI/Northwestern University Clinical Trials Costs and Charges Project, which addresses phase I studies, and the economic projects built into several of the health policy initiatives will provide empirical data that allow for derivation of generalizable estimates of the costs of clinical trials. The small cost increment observed in pilot studies to date is justified by the additional benefits that clinical trials bring to all patients. If increased clinical trial enrollment could facilitate the completion of a trial that demonstrates an innovative therapy to be effective or a current therapy to be ineffective even a year earlier, thousands of lives could potentially be saved. Moreover, clinical trials remain our best source of information on drug safety. During phase I, II, and III clinical trials, reporting of adverse events is virtually complete, with comprehensive reports of these events as well as assessments of possible or definite causality. Identification of rare but potentially fatal side effects is facilitated in the clinical trial setting. There are three strategic options for addressing clinical trial reimbursement: litigation, legislation, and voluntary cooperation. Litigation, as might be suggested by the bone marrow transplant studies in breast cancer, may be unlikely to lead to the most coherent, egalitarian, and entirely scientific reimbursement policy. Legislation and voluntary industry initiatives are the most probable paths to rational health policy decisions about clinical trial reimbursement. Initiatives such as the DOD/NCI cancer clinical trials demonstration project have started slowly, but the numbers of participants in the DOD demonstration in 2000 almost doubled from the year before and will most likely double again this year. Several states, several large private insurers, and Medicare have agreed to reimburse for medical care that occurs in the setting of certain clinical trials, although phase I clinical trials are frequently excluded. Medicare has made the largest leap in extending coverage to all clinical trials and drafting criteria to extend the range of qualified clinical trials beyond those sponsored by the NIH, DVA, or DOD. The New Jersey Working Group expects that their health insurance cooperative agreement, which covers 98% of insured patients in New Jersey, will increase the 3.3% rate of New Jersey cancer patients currently on clinical trials to 15% in 3 years. Most major improvements in cancer treatment have been accomplished through controlled clinical trials. While a Harris Interactive survey found that both the general public as well as persons who participated in cancer trials had a favorable impression of clinical trials,2 only 4% of cancer patients participate in these studies. If recruitment to clinical trials continues to be poor, then the generalizability and timeliness of clinical trial findings will be jeopardized. Enrolling large numbers of patients onto clinical trials facilitates translational efforts to identify the most effective medical treatments, enhances comprehensive assessments of drug safety, and helps identify therapies that are likely to be ineffective. Finally, if empirical data continue to show that clinical trials result in only modest increases in costs, and if broad-based policy initiatives continue to occur, then there is no reason that clinical trial coverage should not ultimately be a permanent benefit that is supported by federal, state, and private sector policies.
We thank Deborah Kamin, PhD, of the Department of Public Policy, American Society of Clinical Oncology, Alexandria, VA, for helpful comments.
The opinions expressed herein are solely those of the authors and are not meant to represent those of the committees and departments at the American Society of Clinical Oncology or the American Society of Hematology, where some of the background information was obtained.
1. Aaron HJ, Gelband H (eds): Extending Medicare Reimbursement in Clinical Trials: Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries. Washington, DC, National Academy Press, 2000 2. Comis RL, Aldigé CR, Stovall EL, et al: A Quantitative Survey of Public Attitudes Towards Cancer Clinical Trials. Http://www.cancertrialshelp.org/cnccg_info/news.html 3. NIH Clinical Trials: Various Factors Affect Patient Participation. Washington, DC, US General Accounting Office, 1999, Publication No. GAO/HEHS-99-182 (available at www.gao.gov)
4.
Wagner JL, Alberts SR, Sloan JA, et al: Incremental costs of enrolling patients in clinical trials: A population based study. J Natl Cancer Inst 91: 847-53, 1999 (published erratum appears in J Natl Cancer Inst 92:164-165, 2000)
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Fireman BH, Fehrenbacher L, Gruskin EP, Ray GT: Cost of care for patients in cancer clinical trials. J Natl Cancer Inst 92: 136-142, 2000 6. Barlow W, Taplin S, Seger D, et al: Medical Care Costs of Cancer Patients on Protocol. NCI Meeting, Bethesda, MD, July 7, 1998. Cited by Aaron HJ, Gelband H (eds): Extending Medicare Reimbursement in Clinical Trials: Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries. Washington, DC, National Academy Press, 2000
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Bennett CL, Stinson TJ, Vogel V, et al: 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. J Clin Oncol 18: 2805-2810, 2000 8. Quirk J, Schrag D, Radzyner M, et al: Clinical trial costs are similar to and may be less than standard care and inpatient (InPT) charges at an academic medical center (AMC) are similar to major, minor, and non-teaching hospitals. Proc Am Soc Clin Oncol 19: 433a, 2000 (abstr 1696) 9. Bennett CL, Westerman IL: Economic Analysis During Phase III Clinical Trials: Who, What, When, Where, and Why? Oncology 9: 1-7, 1995
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Goldman DP, Schoenbaum ML, Potosky AL, et al: Measuring the incremental cost of clinical cancer research. J Clin Oncol 19: 105-110, 2001 11. Brown M, McCabe M, Schulman KA: Integrating economic analysis into cancer clinical trials: The National Cancer Institute–American Society of Clinical Oncology Economics Workbook. J Natl Cancer Inst Monogr 24: , 1998 12. Finkler SA: The distinction between cost and charges. Ann Intern Med 96: 102-109, 1982 13. Cancer Clinical Trials: Medicare Reimbursement Denials. Washington, DC, US General Accounting Office, 1997, Publication No. GAO/HEHS-98-15R (available at www.gao.gov) 14. Smith M: Mystery: United HealthCare paying for clinical trials, but patient participation still lags. Oncology Times September 6, 1999 Submitted December 28, 2000; accepted August 20, 2001.
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Copyright © 2001 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
