Costs in Clinical Trials for Medicare Beneficiaries.) The Lewin Group, Fairfax, Va., 1999.

Doll, R. 1982. Clinical trials: Retrospect and prospect. Star Med 1:337–44.

Evans, R. 1992. Public and private insurer designation of transplantation programs. Transplantation 53(5): 1041–6.

Fireman, B., L. Fehrenbacher, L. Gruskin, and T. Ray. 1998. The Cost of Care in Cancer Clinical Trials at Kaiser Permanente, Northern California. NCI Meeting, Bethesda MD: July 7.

Fisher, R. A. 1926. The arrangement of field experiments. J Ministry Agricult Gt Brit 33:503–13.

Fisher, R. A. 1935. The Design of Experiments. Edinburgh: Oliver and Boyd.

Hartwig, J. E. 1996. Medical Coverage of Investigational Devices. Testimony Before the Committee on Governmental Affairs, Permanent Subcommittee on Investigations, U.S. Senate, February 14, 1996.

Health Care Financing Administration/Food and Drug Administration. 1995. Interagency Agreement Between the Food and Drug Administration and the Health Care Financing Administration Regarding Medicare Coverage of Certain Investigational Medical Devices (IDE Memorandum D95-2). Photocopy.

Hennekens, C. H., and J. E. Buring. 1987. Epidemiology in Medicine . Boston: Little, Brown, and Co.

Holohan, T. V., and H. Handelsman. 1996. Lung-volume reduction surgery for end-stage chronic obstructive pulmonary disease. Health Technol Assess (Rocky) 10(Sept.): 1–30.

Lilienfeld, A.M. 1982. Ceteris paribus: The evolution of the clinical trial. Bull Hist Med 56: 1–18.

McCray, A. National Library of Medicine, NIH. 1999. Personal communication to H. Gelband.

Medical Research Council. 1948. Streptomycin treatment of pulmonary tuberculosis. BMJ 2:769–82.

Meinert, C. L. 1986. Clinical Trials: Design, Conduct, and Analysis . Oxford: Oxford University Press, pp. 3–10.

Newcomer, L. 1999. Medical Director, United Health Group, personal communication, August 1999.

O'Rourke, P. 1999. Office of the Director, NIH. Personal communication to Hellen Gelband.

Szymanski, J. 1999. Office of the Assistant Secretary of Defense (Health Affairs), personal communication, October 1999.

U.S. General Accounting Office. 1997. Cancer Clinical Trials: Medicare Reimbursement Denials (GAO/HEHS-98-15R). Washington, D.C.: GAO.

U.S. General Accounting Office. 1999. NIH Clinical Trials: Various Factors Affect Patient Participation (GAO/HEHS-99-182). Washington, D.C.: GAO.

Wagner, J. L., S. R. Alberts, J. A. Sloan, S. Cha, J. Killian, M. J. O'Connell et al. 1999. Incremental costs of enrolling cancer patients in clinical trials: A population-based study. J Natl Cancer Inst 91(10):847–53.

Zelen, M. 1993. Large simple trials. In Clinical Trials and Statistics: Proceedings of a Symposium. Washington, D.C.: National Academy Press.