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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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Suggested Citation:"References." Institute of Medicine. 1989. Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper. Washington, DC: The National Academies Press. doi: 10.17226/9924.
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References 1. Ahlquist RP: Study of adrenotropic receptors. Am. J. Physiol. 1948;53:586-600. 2. Allen TJ: Communication Networks in R&D Laboratories. R&D Management 1970;1:14-21. 3. Altman SM: Impact of the Changing Medical Payment System in Technological Innovation and Utilization. In: Ekelman K (ed): New Medical Devices: innovation, development and use. National Academy Press, 1988. pp 93-103. Anderson OF, Steinberg E: To buy or not to buy technology: Acquisition under prospective payment. N Engl J Med 1984;311:182-185. 5. Arthur D. Little. Medical device safety and efficacy testing PB 83-105-031; PB 83-105-049; PB 82-1~13-036. 6. Baily MN: Research and development costs and returns: the US pharmaceutical industry. J Political Economy 1972;80:78-85. Bakke OM, Wardell WM, Lasagna L: Drug discontinuations in the United Kingdom and the U.S., 1964 to 1983: issues of safety. Clinical Pharmacology & Therapeutics 1984;35:559-567. 8. Barnes BA: Discarded operations: surgical innovation by trial and error. In: Bunker JP, Barnes BA, Mosteller F (eds): Costs, Risks and Benefits of Surgery. Oxford University Press, 1977. pp 109-123. 9. Barton Hutt P: Medical device regulation: Reasonable workable. Legal Times Washington, May 1980. 10. Barton Hutt P.: Regulation in the United States. Int Journal of Technology Assessment in Health Care 1986;2:619-628. 11. Bergkamp L: American IRBs and Dutch Research Ethics Committees: how they compare. IRB A Review of Human Subjects Research. Hastings Center 1988;10:1-6. 12. Bergner M: Quality of Life, Health Status, and Clinical Research (to be published in Medical Care). Bernal JD: Science in History. Volume I-IV. Illustrated edition. Pelican Books, 1969. 14. Berlin H. Jonsson B.: International Dissemination of new drugs: a comparative study of six countries. Managerial and Decision Economics 1986;7:235-242. 15. Black JW, Stephenson JS: Pharmacology of a new adrenergic beta-receptor-blocking compound (nethalide). Lancet 1962;2:311-3-14. 1 6. Black JW, CroYYther AF, Shanks RG, Smith LH, Dornho rst AC: A new adrenergic beta - receptor antagonist. Lancet 1964;1:1080-1081. 55

17. Blozan CF, Gieser NC, Tucker SA: A profile of investigational device exemption applications. OPE study 76, November 1987. Food and Drug Administration, Rockville, MD. 18. Bonchek LI: The role of the randomized clinical trial in the evaluation of new operations. Surg. Clin. North Am. 1982;62:761-769. 19. Bonchek LI: Are randomized trials appropriate for evaluating new operations? N Engl J Med 1979;301:44-45. 20. Borden EK, Lee JO: A methodological study of post-marketing drug evaluation using a pharmacy-based approach. J Chron Dis 1982;35:803-816. 21. Bunker JP, Barnes BA, Mosteller F: Costs, Risks and Benefits of Surgery. Oxford University Press, 1977. 22. Bunker JP, Hinkley D, McDermott WV: Surgical innovation and its-evaluation. Science 1978;200:937-941. 23. Buxton M: Problems in the economic appraisal of new health technology: the evaluation of heart transplants in the United Kingdom. In: Drummond ME (ed.) Economic appraisal of health technology in the European Community. Oxford Medical Publications, 1987. 24. Carr SW, Jones JH: Drug epidemiology data bases applicable to medical device monitoring. Medical Device Data Base Conference, Washington D.C., AMA, October 1983. 25. Casimir HBG: Haphazard reality, half a century of science. New York, Harper & Row Publishers, 1983. 26. Chalmers TC: Randomization and coronary a-rte~y surgery. Annals of Thoracic Surgery 1972;14:323-327. 27. Chalmers TC: The clinical trial. Milbank Memorial Fund Quarterly 1981;59:324-339. 28. Code of Federal Regulations, section 860.3. 29. Cody E: France orders sale of new pill. Washington Post, 1988. 30. Comroe JH, Dripps RO. Scientific basis for the support of biomedical science. In: Roberts EB, Levy RI, Finestein SW, Moskowitz J. Sondik EJ: Biomedical innovation. Cambridge, MIT Press, 1981. 31. Cuatrecasas P.: Contemporary drug development - dilemmas. The Center for the Study of Drug Development Publication Series. New York, University of Rochester, 1983. 32. Dimond KG, Kittle CF, Crockett JE: Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol 1960;5 483~486e 33. Doyle AK: Biologic end-points as surrogates for clinical outcomes. In: Lasagna L, Bearn AG feds): Innovation and acceleration in clinical drug development. New York, Raven Press, 1987, pp 177-123. 56

34. EC/IC Bypass Study Group: Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. N Engl J Med 1985;313:1191-1200. EC/IC Bypass Study Group: Are the Results of the Extracranial-Intracranial Bypass Trial Generalizable? N Engl J Med 1987;13:820-824. 36. Eddy DM, Billings J: The quality of medical evidence: implications for quality of care. Health Affairs 1988;Spring:20-32. 37. Eden M: The engineering-industrial accord: inventing the technology of health care. In: Reiser SJ, Anbar M: The machine at the bedside. Cambridge University Press, 1984. 38. Eschbach: Presentation at the Institute of Medicine. New Biology Workshop, September 1987. 39. Federal Food, Drug, and Cosmetic Act, as amended, Sec. 505 (d) 40. Food and Drug Administration (FDA): The Code of Federal Regulations. Section 860.3. 41. FDA Consumer Special Report: From test tube to patient: New drug development in the U.S. Rockville, MD, January 1988. 42. FDA Office of Planning and Evaluation: Assessment of the economic impact of revisions to regulations governing the submission of investigational new drug applications. Rockville, MD, 1984. 43. FDA Office of Planning and Evaluation: Final regulatory impact analysis of changes to regulations governing the submission and review of new drug applications. Part 314. Title 21. Rockville, MD, August 1983. ~ , .1 , 44. Feinstein AR: An additional basic science for clinical medicine: II. The limitations of randomized trials. Ann Internal Med 1983;49:544-550. Also see: I. The constraining fundamental paradigms. III. The challenges of comparison and measurement. IV. The development of clinimetrics. 45. Feinstein AR: Clinical Biostatistics. St. Louis, Mosby, 1977. 46. Feinstein AR: Scientific studies in epidemiological studies of the menace of daily life. Science 1988;242:1257-1263. 47. Felig P: Biomedical research in the industrial setting. Contrasts and similarities to academia. JAMA 1987;258:2407-2409. 48. Fineberg HV, Bauman R. Susman M: Computerized cranial tomography: Effect on diagnostic and therapeutic plans. JAMA 1977;238:224-230. 49. Food, Drug and Cosmetic Act, Section 501 to 521. 50. Fox RC, Swazey J.: The courage to fail: a social view of organ transplants and dialysis. Chicago, University of Chicago Press, 1974. 57

51. Fox, RC: The cultural shaping of biomedical science and technology. A preface. International Journal on Technology Assessment in Health Care 1986;2:189-194. 52. Freeman C, Clark J. Soete L: Unemployment and Technical Innovation. London, 1982. 53. Friedman PJ: The early evaluation of MR imaging. Am J Radiol 1988;151:860-861. 54. Frishman WH: Clinical differences between beta-adrenergic agents: Implications for therapeutic substitution. Am Heart J 1987; 113:1190- 1198. 55. General Accounting Office: Medical Devices - FDA's 510 (k) operations could be improved. August 1988. General Accounting Office: FDA Drug Approval - a lengthy process that delays the availability of important new drugs. Hearings before the Subcommittee on Science, Research and Technology. May 1980. 57. Gilbert JP, McPeek B. Mosteller F: Statistics and ethics in surgery and anesthesia. Science 1977;198:684-689. 58. Goodman CS: Guide to comparative clinical trials. In: Committee for Evaluating Medical Technologies, Institute of Medicine: Assessing Medical Technologies. Washington, D.C., National Academy Press, 1985, pp 490-505. 59. Goyan JE: Drug regulation: Quo vadis? JAMA 1988;260:3052-3053. 60. Grabowski HO, Vernon J. Thomas L: Estimating the effects of regulation on innovation: an international comparative analysis of the pharmaceutical industry. J Law & Economics 1978;21:1-32. 61. Grabowski HO: Health care cost containment and pharmaceutical innovation. Center for the Study of Drug Development, 1986. Reprint RS S707 62. Green SB, Byar DP: Using observational data from registries to compare treatments: the fallacy of omnimetrics. Statistics in Medicine 1984;3:361-370. 63. Greer AL: Adoption of medical technology. The hospital's three decision-systems. International Journal on Technology Assessment in Health Care 1985;1:669-80 64- Hanssen RW: The pharmaceutical development process: estimates of development costs and times and the effects of proposed regulatory changes. In: Chien RI: Issues in pharmaceutical economics. Lexington, MA, 1979. Hass AK, Portable DP, Grossman RE: New Drug introductions, discontinuations and safety issues in the United States and the United Kingdom: 1960-1982. OPE (FDA) study 68. 66. Hauptman O. Roberts EB: FDA regulation of product risk and its impact upon young biomedical firms. Journal of Product Innovation Management 1987;2:138-148. 67. Hillman BJ: Government health policy and the diffusion of new medical devices. Health Services Research 1986;21:681-711. 58

68. van Hippel E: The dominant role of users in the scientific instrument innovation process. Research Polipy 1976;3:212-239. 69. van Hippel E, Finkelstein S: Product designs which encourage or discourage related innovations by users: an analysis of innovation in automatic clinical chemistry analyzers. MIT, 1978. 70. Hlatly MA, Lee KL, Harrel FE, Califf RM, Pryor OB, Marck DB, Rosatti RA: Tying clinical research to patient care by use of an observational database. Statistics in Medicine 1984;3:375- 384. 71. Horowitz RI, Feinstein AR, Crede WE, Clemens JD: Does technology work? Judging the validity of clinical evidence. In: Reiser SJ, Anbar M teds): The Machine at the bedside. Cambridge University Press, 1984, pp 193-208. 72. Inman WHW: Drug Surveillance Research Unit. Letter from the director. University of Southampton. PEM News 1983;N1. 73. IDE regulations. 45 Fed. Reg. 3732, 1980. 74. Joint Commission on Prescription Drug Use, Inc. Final Report. Washington, D.C., Government Printing Office, April 1980. 75. Jones JK: Regulatory use of adverse drug reactions. Stockholm, Skandia International Symposia, Almquist G. Wichsell International, 1984, pp 203-214. 76. Kaitin KI, Richard BW, Lasagna L: Trends in drug development: the 1985-86 new drug approvals. J Clin Pharm 1987;27:542-548. 77. Kaye HL: The biological revolution and its cultural context. International Journal on Technology Assessment in Health Care 1986;2:275-2%4. 78. Kennedy RS: Clinical investigations with medical devices: new rules. JAMA 1981;245:2053- 2054. 79. Kessler DA, Pape SM, Sundwall DN: The federal regulation of medical devices. N Engl J Med 1987:317:357-365. 80. Kline SJ, Rosenberg N: An overview of innovation. In: Landau R. Rosenberg N teds): The positive sum strategy. Washington, D.C., National Academy Press, 1986, pp 275-306. 81. Kowey PR, Fisher L, Giardina KG, Leier CV, Lowenthal DT, Messerli FH, Pratt CM: The TPA controversy and the drug approval process. The view of the cardiovascular and renal drugs advisory committee. JAMA 1988;260:2250-7252. 82. Landau R. Rosenberg N: The Positive Sum Strategy. Washington, D.C., National Academy Press, 1986. 83. Lasagna L, Bearn AG: Innovation and acceleration in clinical drug development. Raven Press, New York 1987. Roundtable 2: early clinical trials-Phase I-IIA: optimal designs for maximum information. pp 95-103. 59

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