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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

From the Robert H. Lurie Comprehensive Cancer Center, the Division of Hematology/Oncology, and the Institute for Health Services Research and Policy Studies of Northwestern University, and the Veterans Administration Chicago Health Care System–Lakeside, Chicago, IL; University of Pittsburgh Cancer Institute, Pittsburgh; Fox Chase Cancer Center, Philadelphia, PA; Jonsson Comprehensive Cancer Center-University of California at Los Angeles, Los Angeles, CA; H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Tulane Cancer Center, New Orleans, LA; and the Association of American Cancer Institutes and the University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.

Address reprint requests to Charles L. Bennett, MD, PhD, Veterans Administration Chicago Health Care System–Lakeside, 400 E Ontario Ave, Chicago, IL 60611; email cbenne{at}northwestern.edu

ABSTRACT

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials.

METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer.

RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P = .4)

CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

MUCH CONCERN HAS been raised about the expense of clinical trials in oncology, despite the fact that only 3% of adult cancer patients actually participate in clinical trials. A major barrier to clinical trial accrual is related to financial considerations.^1-3 Many private insurers often do not reimburse providers for care associated with clinical trials and often deny payment for any medical care delivered to patients who are enrolled onto these trials. In June 2000, President Clinton ordered Medicare to reimburse for medical care that occurs in the context of clinical trials. Moreover, two large private insurers, the Mayo Health Plan and United Health Care, established policies in the late 1990s that reimburse for patient care costs incurred alongside National Cancer Institute (NCI)–associated clinical trials. However, fewer than 50 patients have actually been enrolled onto clinical trials as a result of these new policies.^4,5

Policy makers focused on the financial aspects of cancer clinical trials as they considered enacting legislation or policies for clinical trials.⁶ The Medicare Cancer Clinical Trial Act of 1997 sought to authorize a $750 million demonstration project that would have required reimbursement for routine patient care alongside an approved clinical trial, with a report to Congress due by January 1, 2002. The clinical trials that would have been covered were those that were conducted by a program that was approved by the National Institutes of Health (NIH), the national cooperative clinical trial groups, the United States Food and Drug Administration, the Department of Veterans Administration, the Department of Defense, or an NIH-sponsored cancer center. However, this legislation was not passed as a result of concerns over the actual economic impact of the policy, as well as the expense of the demonstration project. President Clinton’s June 2000 policy order supporting clinical trial costs for Medicare recipients obviates the need for the Medicare demonstration project.

The President and Congress have been influenced in their efforts by estimates of the costs of clinical trials. Original estimates from the Congressional Budget Office were that costs of care alongside clinical trials were 25% greater than those associated with routine clinical practice, accounting for some of the hesitation in approving the Medicare Cancer Clinical Trial Act.⁵ A high but declining portion of trial-related patient care costs was estimated by the Congressional Budget Office to be paid by private health insurance plans, because NIH covers only research costs and occasionally provides free pharmaceuticals when they are associated with an investigational agent. Until recently, empirical data on both the costs and charges of clinical trials have been lacking. The Mayo Clinic estimated that during the years 1988 through 1994, the costs of care for 61 clinical trial patients were found to be 3% to 13% greater in comparison with a matched control sample.⁷ These data led the Congressional Budget Office to revise its estimates of incremental clinical trial costs to 10%.

The Association of American Cancer Institutes (AACI), a consortium of cancer institutes, has initiated a project to help inform policy makers on the costs and charges of NCI-sponsored phase I, II, and III clinical trials at cancer centers. After review of a pilot report on the feasibility, expense, and timeliness of data collection efforts, AACI member institutions will provide detailed cost and charge information on phase I, II, and III clinical trial patients and a matched cohort of patients not on clinical trials. In this report, we describe the overall goals and study methods and present the first set of pilot data for phase II clinical trials from the AACI/Northwestern University Cancer Clinical Trial Costs and Charges Project.

METHODS

The AACI is a voluntary organization made up of representatives of cancer centers in the United States. For this study, centers were selected from regions with congressional members who were involved with federal legislative efforts related to reimbursement of clinical trials. These regions included Alabama, California, the District of Columbia, Florida, Louisiana, Massachusetts, Texas, New York, Illinois, Michigan, Ohio, Vermont, and Pennsylvania. The selected cancer centers included the University of Alabama at Birmingham Cancer Center, the Jonsson Comprehensive Cancer Center of the University of California at Los Angeles, the Lombardi Cancer Center of Georgetown University, the H. Lee Moffitt Cancer Center of the University of South Florida, the Tulane Cancer Center, the Dana-Farber Cancer Institute, the University of Michigan Cancer Center, the Memorial Sloan-Kettering Cancer Center, the Arthur James Cancer Center of Ohio State University, the Fox Chase Cancer Center, the University of Pittsburgh Cancer Institute, the M.D. Anderson Cancer Center, the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and the University of Vermont Cancer Center. A physician principal investigator and a financial investigator were appointed from each of the selected AACI cancer centers. The coinvestigators attended an introductory meeting that described the goals of the study, heard presentations from investigators at the Mayo Clinic, Memorial Sloan-Kettering, and the NCI who were involved in similar studies, and assisted with designing the project. Frequent conference calls followed to optimize the methodology. Because the timing of completion of the pilot study was targeted to provide background information for congressional members and staff who were proposing Patient Bill of Rights legislation for the 1999 congressional session, investigators devised a simple pilot study protocol that could be completed in a short time period with minimal resources. The economic analyses were based on the perspective of a third-party payer.

The physician principal investigators from each site were asked to recruit physicians from their cancer centers who treated the following common cancers: breast, colorectal, lung, prostate, ovarian, and lymphoma. Each investigator was asked to identify three to five patients treated for cancer in their specialty area on a phase II clinical trial and match these to patients treated using a standard regimen on the basis of age, sex, disease, stage, and treatment period. Information was also provided on the dates and type of treatment received for each patient. Patients selected were to be those who received all or most of their treatment at the cancer institute from 1996 through 1998. The financial coinvestigator was asked to obtain complete inpatient and outpatient billing data files for each patient, from the time of study enrollment (or the corresponding phase in treatment for standard-regimen patients) through 6 months.

Financial data (automated hospital billing files) and clinical data (abstracted by investigators) were de-identified and sent to economic analysts at Northwestern University. A tear sheet at the bottom of each case report form was the only identification of whether patients were treated on clinical trials or by standard methods. Data entry was blinded as to whether patients were on phase II clinical trials. Billing information was cross-checked for completeness using treatment dates and therapy descriptions provided on the case report forms. Descriptive statistics were summarized for the clinical characteristics of the study population, including age, sex, disease, and stage. Pearson ² tests were used to analyze differences in proportions. Mean total charges (inflation adjusted to 1998 US$) were compared using paired t tests. Mann-Whitney U tests were used to compare median values. All type 1 error rates were set at 5%, and testing procedures were two-sided. The observed SD of the difference in total charges was $44,610, so the 35 paired samples provided 80% power to detect a difference of $29,882.

RESULTS

Thirty-five matched pairs of patients from five cancer institutes were evaluated in this pilot effort. The majority of the patients were treated for breast cancer (n = 12 pairs), lung cancer (n = 9 pairs), and colon cancer (n = 8 pairs), but the data set also included prostate cancer (n = 2 pairs) and lymphoma (n = 4 pairs). Approximately 56% of the patients were treated by chemotherapy regimens alone, 19% with high-dose therapy with stem-cell rescue, and 19% with chemotherapy plus radiation. The study groups were evenly matched on the basis of clinical factors (Table 1). The mean age was 57 to 58 years and 43% were male. Approximately one quarter of the patients had stage III disease at the time of treatment, and more than 50% had stage IV disease. Both study groups had a similar proportion of survivors during the 6-month study period (33 of 35 for the clinical trial group and 34 of 35 for the control group). The nonsurviving patients in the clinical trial group were on study for 5.5 months, and the control patients for 4 months.

View larger version (40K): [in this window] [in a new window]   Fig 1. Mean 6-month total charges (1998 US$) by disease: clinical trial versus control patients. Differences in charges for clinical trial patients were not significant from those for control patients. Abbreviations: Pts, patients; Ca, cancer.

View larger version (15K): [in this window] [in a new window]   Fig 2. Charge comparison (log scale) for case-matched trial and control patients (1998 US$).

Medicare and third-party payer coverage of clinical trial cancer treatment has been controversial. The AACI has undertaken a broad effort to help inform this debate. This article is the first report from the AACI/Northwestern University Cancer Clinical Trials Costs and Charges Project, an evaluation of financial information for clinical trial participants associated with phase II clinical trials conducted at NCI-designated comprehensive cancer centers. Proposed future analyses will include the costs and charges of phase I clinical trial patients (which will include individuals with all types of cancer diagnoses) and phase III clinical trial patients (which will include only patients with lymphoma or breast, lung, colorectal, prostate, and ovarian cancer). For each clinical trial patient, a control patient will be identified with the same approximate age, disease, stage, and time frame of treatment. For both the clinical trial patient and control patients, detailed financial information will be collected for a retrospective 6-month time period for phase I and phase II trials, and for a 2-year period for phase III trials. Medicare as well as privately insured patients will be included in the study.

This study illustrates that our proposed strategy for obtaining financial information for clinical trial participants and a comparison group of patients can be readily carried out at several collaborating cancer centers. First, we were able to complete these analyses in a 5-month period by building on methods for financial data collection and analysis that have been developed by us and others, coordinating the economic study analysis with cancer center leadership at each participating center and working with a multidisciplinary project team that has been evaluating costs of cancer care for a decade.^8-14 Second, we addressed operational considerations, such as identifying control patients, by working closely with clinicians at individual institutions who had large clinical practices for each of the selected tumor types. Third, our economic analyses were based on detailed financial information obtained from each study site, where good communication channels had been developed with cancer center directors, physicians, and personnel in the finance departments. Data were available primarily in electronic form, allowing for affordable data entry as well as an evaluation of data quality. Fourth, good communication channels with the central office of the AACI were maintained throughout the project by frequent email and phone conversations. These operational issues are important to decision makers at cancer centers who must decide how to use resources that are scarce.

This project represents the first multisite attempt at evaluating the financial impact of clinical trials conducted by the AACI. In addition to receiving the results of our analyses, cancer center directors involved in the AACI have received feedback of the type and amount of work performed by clinicians, health services researchers, finance departments, and policy researchers; the costs of the study; and the levels of oversight that accompanied the data analysis to prevent bias in the evaluation. To make important policy decisions related to support for clinical trials, policy makers require detailed economic information but must be able to obtain these data without disrupting the conduct of clinical efforts.

Our pilot study results from 70 cancer patients enrolled on phase II clinical trials found that, in 1996, charges for participants on cancer-related clinical trials were no greater than charges for participants incurred outside of the clinical trial setting. These estimates can be compared with those reported from other recent single-site studies. The Mayo Clinic reported that costs (not charges) of care for 122 matched cancer patients treated during an earlier time period, from 1988 to 1994, were similar for patients on a clinical trial and were not statistically different ($12,200 v $10,073).⁷ Similarly, 6-month cost (not charge) estimates for 135 clinical trial and 135 matched control patients at Kaiser health maintenance organizations during 1994 to 1997 were similar to those reported from the Mayo Clinic ($12,242 v $9,930).¹⁵ Two studies found that the financial impact of clinical trial participation was less than that associated with standard medical care. Preliminary findings from a study of 152 matched Medicare cancer patients from Memorial Sloan-Kettering Cancer Center, an AACI member institution, found mean 6-month charges similar to those found in our study and a 17% savings associated with participation in clinical trials in 1995.¹⁶ Six-month costs (not charges) for advanced lung cancer patients treated at the Karmanos Cancer Center in Detroit were $1,400 less on average for clinical trial participants.¹⁷ Taken together, the findings seem to have influenced policy makers in individual states. Comprehensive clinical trial legislation has been enacted in Rhode Island (July 1997), Maryland (May 1998), Georgia (July 1998), Virginia (April 1999), Louisiana (June 1999), Illinois (August 1999), and New Jersey (December 1999).¹⁸ In June 2000, immediately after the presentations of the data from the AACI and Memorial Sloan-Kettering at the May 2000 American Society of Clinical Oncology Annual Meeting, President Clinton ordered the federal Medicare program to reimburse for medical care costs alongside clinical trials.

This project was designed with several objectives in mind. First, our pilot data were presented at briefings to policy makers who were considering congressional and presidential initiatives for clinical trial reimbursement, as outlined in various Patient Bill of Rights proposals introduced by congressional members in 1999, and more recently in the text of President Clinton’s order to Medicare.¹⁷ The first meeting of the AACI investigators occurred in February 1999, data were received from the first three centers within 2 months, and the pilot data analyses were completed within 5 months. Although a recently initiated RAND (Santo Monica, CA)/NCI study is designed to be comprehensive in scope, complete results may not be available until 2002. Second, the study methods must be valid. At our initial meeting, representatives from each of the AACI programs reviewed methodologic approaches associated with studies from the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, the Kaiser Permanente Health System, the Group Health system, and the NCI. Senior investigators from the NCI clinical trials and economics programs attended this initial meeting. Subsequent decisions about patient eligibility, data sources, and time frame were made by both physician and health services researchers. The final study protocol was reviewed by a senior investigator from the NCI Cancer Clinical Trial Cost Study and revisions were made on the basis of these comments. The overall methods were based on those reported previously as developed by health economists at Northwestern University and the NCI/American Society of Clinical Oncology Working Group on Cancer Costs and used in cost-effectiveness studies carried out in conjunction with the Eastern Cooperative Oncology Group, the Pediatric Oncology Group, and the Southwest Oncology Group, three of the largest NCI-sponsored cooperative clinical trial groups.^8-13 The expense of data collection efforts was borne entirely by the individual study institutions, without the benefit of external grant support. The study team for the project included a physician and a representative of hospital finance from each institution, who helped facilitate these efforts. Finally, the project has been designed to occur in stages. The initial efforts for the project were targeted to a small number of AACI centers to identify operational, institutional, financial, and intellectual concerns that would impact the subsequent roll-out of the project to the remaining AACI centers. Subsequent reports are proposed to include data from all 14 centers and incorporate economic information from phase I, II, and III clinical trials.

The limitations of our study design should be identified. First, the sample size of 70 patients is small but similar to that included in other recently reported estimates of clinical trial costs. However, our pilot results allow us to estimate that we will have adequate power to detect meaningful differences in costs and charges between clinical trial and control patients in our study of 2,100 patients enrolled on phase I, II, or III studies. Second, there is the potential for bias in the manner that the patients were selected. Investigators were asked to select three trial patients for a specific cancer, but instructions were not provided on how to do this in a random manner or by any bias-limiting selection process. In contrast, the Mayo Clinic and Kaiser studies of cancer trial costs matched on patient eligibility for specific clinical trials. As such, our study could have included patients with much more heterogenous conditions relative to the clinical trial patients. Third, data were collected from five study institutions, which limits the generalizability of our findings. Fourth, our data were based on charges, not costs. Charges are always greater than costs, as evidenced by the mean charge for stem-cell transplantation patients of $120,000 in this study, in comparison with previously reported estimates of costs that are approximately one third to one quarter as great and mean 6-month charge estimates in the range of $60,000 in our study versus 6-month cost estimates from the Mayo Clinic and Kaiser health maintenance organizations that are only one fifth as great.^7,15,19,20 Although hospital-specific and resource-specific cost-to-charge ratios are available from the finance departments at each of our study institutions, these ratios vary markedly for individual resources and among the various cancer centers. Future analyses will report comparisons of both costs and charges for clinical trial and control patients. Finally, the selected time frame chosen for the study can influence the study results. Costs and charges of care in the first 6 months of treatment are likely to be less than those that are observed shortly before death, and the differences in costs and charges between clinical trial and control patients might be less. However, only three deaths were noted among our 70 study patients during the 6-month study period. The impact of clinical trial participation on terminal care costs will undoubtedly require a longer time period for evaluation.

In conclusion, the AACI/Northwestern University Cancer Clinical Trial Costs and Charges Project is likely to be an important source of information for policy makers faced with legislation about funding of cancer clinical trials. Pilot data on the charges associated with phase II clinical trials were completed in 5 months’ time, followed methods outlined by investigators involved in similar studies in other settings, and were obtained without the need for external funds. These feasibility concerns are especially relevant today as cancer center directors consider participation in the larger AACI/Northwestern University Cancer Clinical Trials Costs and Charges Project, which will include 2,100 patients at 14 cancer centers who participated in phase I, II, and III clinical trials.

ACKNOWLEDGMENTS

We thank Brad T. Smith of the H. Lee Moffitt Cancer Center, Alan Howald of the Fox Chase Cancer Center, and Diana Gesshel of the Jonsson Cancer Center-University of California at Los Angeles for their enormous efforts with data retrieval.

NOTES

Funding for this study was obtained from the Association of American Cancer Institutes and its member institutions.

REFERENCES

1. Patient care costs of clinical trials may be less than standard care. Oncology News International 8:2, 1999

2. Brown ML: Cancer patient care in clinical trials sponsored by the National Cancer Institute: What does it cost? J Natl Cancer Inst 91:818-819, 1999[Free Full Text]

3. Mechanic RE, Dobson A: The impact of managed care on clinical research: a preliminary investigation. Health Aff (Millwood) 15:72-88, 1996[Abstract]

4. Pear R: Managed care plans agree to help pay the costs of their members in clinical trials. New York Times, February 9, 1999

5. Smith M: Mystery: United HealthCare paying for clinical trials, but patient participation still lags. Oncology Times 22:6, 2000

6. Congressional Budget Office, US Congress: Congressional budget office cost estimate, H.R. 3605/S: 1980, patients’ bill of rights act of 1998. Washington, DC, July 16, 1998. Http://www.cbo.gov

7. Wagner JL, Alberts SR, Sloan JA, et al: Incremental costs of enrolling patients in clinical trials: A population based study [published erratum appears in J Natl Cancer Inst 92:164-165, 2000]. J Natl Cancer Inst 91:847-853, 1999[Abstract/Free Full Text]

8. Bennett CL, Golub R, Waters AT, et al: Economic analyses of phase III cooperative cancer group clinical trials: Are they feasible? Cancer Invest 15:227-325, 1997[Medline]

9. Bennett CL, Waters AT: Economic analyses in clinical trials for cooperative groups: Operational considerations. Cancer Invest 15:448-453, 1997[Medline]

10. Bennett CL, Stinson TJ, Lane D, et al: A cost-analysis of filgrastim for the prevention of neutropenia in pediatric T-cell leukemia and advanced lymphoma: A case for prospective economic analysis in cooperative group trials. Med Pediatr Oncol 34:92-96, 2000[Medline]

11. Bennett CL, Pajeau TJ, Tallman MS, et al: Economic analysis of a randomized placebo-controlled phase III study of granulocyte macrophage colony stimulating factor in adult patients (>55 to 70 Years of Age) with acute myelogenous leukemia: An Eastern Cooperative Oncology Group (E1490) trial. Ann Oncol 10:1-6, 1999[Free Full Text]

12. Bennett CL, Hynes D, Godwin J, et al: Economic analysis of granulocyte colony-stimulating factor as adjunct therapy for older patients with acute myelogenous leukemia: Estimates from a Southwest Oncology Group clinical trial. Cancer Invest (in press)

13. 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 1-28, 1998

14. Gulati S, Bennett CL: Granulocyte macrophage-colony stimulating factor as an adjunct therapy for relapsed Hodgkin’s disease. Ann Intern Med 116:177-182, 1992

15. Fireman BH, Fehrenbacher L, Gruskin EP, et al: Cost of care for patients in cancer clinical trials. J Natl Cancer Inst 92:136-142, 2000[Abstract/Free Full Text]

16. 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)

17. Eastman P: Medicare system deprives elderly of clinical trials participation, National Coalition for Cancer Res tells Congress. Oncology Times September 1999, pp 40-41,

18. Erikson J: New Jersey HMOs to cover clinical trial routine care costs, in unique agreement. Oncology Times 23:1, 2000

19. Meisenberg BR, Ferran K, Hollenbach K, et al: Reduced charges and costs associated with outpatient autologous stem cell transplantation. Bone Marrow Transplant 21:927-932, 1998[Medline]

20. Finkler SA: The distinction between cost and charges. Ann Intern Med 96:102-109, 1982

Submitted November 22, 1999; accepted April 28, 2000.

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This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Bennett, C. L. Articles by Wicha, M. S. Search for Related Content PubMed PubMed Citation Articles by Bennett, C. L. Articles by Wicha, M. S.