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References
- 1 Amberson, B. & McMahon, P. M. (1931). A clinical trial of sanocrysin in pulmonary tuberculosis, American Review of Tuberculosis 24, 401.
- 2 Armitage, P. (1954). Sequential tests in prophylactic and therapeutic trials, Quarterly Journal of Medicine 23, 255–274.
- 3 Armitage, P. (1983). Trials and errors: the emergence of clinical statistics, Journal of the Royal Statistical Society, Series A 146, 321–334.
- 4 Armitage, P. (1991). Interim analysis in clinical trials, Statistics in Medicine 10, 925–937.
- 5 Bacon, F. V. S. (1961–1963). Novum organum, in The Works of Francis Bacon (transl. James Spedding, orig. publ. Longman, London, 1858–1874). Facsimile reprint, Frommann, Stuttgart, 1961–1963. Also cited in The Oxford Dictionary of Quotations, 3rd Ed. Oxford University Press, 1979.
- 6 Bean, W. B. (1995). Walter Reed and the ordeal of human experiments, in Ethics in Epidemiology and Clinical Research, S. S. Coughlin, ed. Epidemiology Resources Inc., Newton, pp. 3–22.
- 7 Beecher, H. K. (1966). Ethics and clinical research, New England Journal of Medicine 274, 1354–1360.
- 8 Berry, D. A. (1987). Interim analyses in clinical research, Cancer Investigation 5, 469–477.
- 9 Bross, I. (1952). Sequential medical plans, Biometrics 8, 188–295.
- 10 Bull, J. P. (1959). The historical development of clinical therapeutic trials, Journal of Chronic Disease 10, 218–248.
- 11 Canner, P. (1983). Monitoring of the data for adverse or beneficial treatment effects, Controlled Clinical Trials 4, 467–483.
- 12 Cornfield, J. (1969). The Bayesian outlook and its applications, Biometrics 24, 617–657.
- 13 Cornfield, J. (1976). Recent methodological contributions to clinical trials, American Journal of Epidemiology 104, 408–421.
- 14 Coronary Drug Project Research Group (1970). The Coronary Drug Project. Initial findings leading to a modification of its research protocol, Journal of the American Medical Association 214, 1303–1313.
- 15 Curran, W. J. & Shapiro, E. D. (1970). Law, Medicine, and Forensic Science, 2nd Ed. Little, Brown & Company, Boston.
- 16 Cutler, S. J., Greenhouse, S. W., Cornfield, J. & Schneiderman, M. A. (1966). The role of hypothesis testing in clinical trials. Biometrics seminar, Journal of Chronic Diseases 19, 857–882.
- 17 The Diabetic Retinopathy Study Research Group (1981). Photocoagulation treatment of diabetic retinopathy. Design, methods, and baseline results. Report 6, Investigative Ophthalmology and Visual Science 21, Part 2, 149–209.
- 18
Diehl, H. S.,
Baker, A. B. &
Cowan, D. W.
(1938).
Cold vaccines: an evaluation based on a controlled study,
Journal of the American Medical Association
111,
1168–1173.
10.1001/jama.1938.02790390024008 Google Scholar
- 19 Ederer, F. (1975). Patient bias, investigator bias and the double-masked procedure, American Journal of Medicine 58, 295–299.
- 20 Faden, R. R., Beauchamp, T. & King, N. M. P. (1986). A History of Informed Consent. Oxford University Press, New York.
- 21 Fibiger, J. (1898). Om Serum Behandlung of Difteri, Hospitalstidende 6, 309–325, 337–350.
- 22 Fisher, R. A. (1926). The arrangement of field experiments, Journal of the Ministry of Agriculture 33, 503–513.
- 23
Fisher, R. A., &
McKenzie, W. A.
(1923).
Studies in crop variation: II. The manurial response of different potato varieties,
Journal of Agricultural Science
13,
315.
10.1017/S0021859600003592 Google Scholar
- 24 Freedman, B. (1995). Research, unethical, in Encyclopedia of Bioethics, W. T. Reich, ed. Free Press, New York, pp. 2258–2261.
- 25 Freedman, L. S. & Spiegelhalter, D. J. (1983). The assessment of subjective opinion and its use in relation to stopping rules for clinical trials, Statistician 32, 153–160.
- 26 Freedman, L. S., Lowe, D. & Macaskill, P. (1984). Stopping rules for clinical trials incorporating clinical opinion, Biometrics 40, 575–586.
- 27 Freedman, L. S., Spiegelhalter, D. J. & Parmar, M. K. B. (1994). The what, why, and how of Bayesian clinical trials monitoring, Statistics in Medicine 13, 1371–1383.
- 28 Fried, C. (1974). Medical Experimentation: Personal Integrity and Social Policy. North-Holland, Amsterdam.
- 29 Friedman, L. (1993). The NHLBI model: a 25-year history, Statistics in Medicine 12, 425–431.
- 30 Friedman, L. M., Furberg, C. D., & DeMets, D. L. (1985). Fundamentals of Clinical Trials, 2nd Ed. Wright, Boston.
- 31 Gail, M. H. (1996). Statistics in action, Journal of the American Statistical Association 91, 1–13.
- 32
Gehan, E. A. &
Lemak, N. A.
(1994).
Statistics in Medical Research: Developments in Clinical Trials.
Plenum Medical Book Company,
New York.
10.1007/978-1-4615-2518-9 Google Scholar
- 33 George, S. L., Chengchang, L., Berry, D. A. & Green, M. R. (1994). Stopping a trial early: frequentist and Bayesian approaches applied to a CALGB trial of non-small-cell lung cancer, Statistics in Medicine 13, 1313–1328.
- 34 Greenhouse, S. W. (1990). Some historical and methodological developments in early clinical trials at the National Institutes of Health, Statistics in Medicine 9, 893–901.
- 35 Hawkins, B. S. (1988). The National Institutes of Health and their sponsorship of clinical trials, Controlled Clinical Trials 9, 103–106.
- 36 Haybittle, J. L. (1971). Repeated assessment of results of cancer treatment, British Journal of Radiology 44, 793–797.
- 37 Hill, A. B. (1962). Statistical Methods in Clinical and Preventive Medicine. E & S Livingstone, Edinburgh.
- 38 Hill, A. B. (1963). Medical ethics and controlled trials, British Medical Journal 1, 1043–1049.
- 39 Hill, A. B., Marshall, J. & Shaw, D. A. (1960). A controlled clinical trial of long-term anticoagulant therapy in cerebrovascular disease, Quarterly Journal of Medicine 29, (NS), 597–608.
- 40 Jennison, C. & Turnbull, B. W. (1989). Interim analysis: the repeated confidence interval approach, Journal of the Royal Statistical Society, Series B 51, 305–361.
- 41 Kadane, J. B. (1995). Prime time for Bayes, Controlled Clinical Trials 16, 313–318.
- 42
Katz, J.
(1972).
Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process.
Russell Sage Foundation,
New York.
10.2307/1227842 Google Scholar
- 43 Katz, J. (1996). The Nuremberg Code and the Nuremberg Trial. A reappraisal, Journal of the American Medical Association 276, 1662–1666.
- 44 Kinsey, V. E. (1956). Retrolental fibroplasia, AMA Archives of Ophthalmology 56, 481–543.
- 45 Lan, K. K. G., & DeMets, D. L. (1983). Discrete sequential boundaries for clinical trials, Biometrika 70, 659–663.
- 46
Lan, K. K. G.,
Simon, R. &
Halperin, M.
(1982).
Stochastically curtailed tests in long-term clinical trials,
Communications in Statistics-Sequential Analysis
1,
207–219.
10.1080/07474948208836014 Google Scholar
- 47 Levine, R. J. (1986). Ethics and Regulation of Clinical Research, 2nd Ed. Urban & Schwarzenberg, Baltimore, pp. 187–190.
- 48 Levine, R. (1995). Research ethics committees, in Encyclopedia of Bioethics, W. T. Reich, ed. Free Press, New York, pp. 2258–2261.
- 49 Lilienfeld, A. M. (1982). Ceteris paribus: The evolution of the clinical trial, Bulletin of the History of Medicine 56, 1–18.
- 50 Lind, J. (1753). A Treatise of the Scurvy. Sands Murray Cochran, Edinburgh, pp. 191–193.
- 51 Louis, P. C. A. (1837). The applicability of statistics to the practice of medicine, London Medical Gazette 20, 488–491.
- 52 McNeill, P. M. (1993). The Ethics and Politics of Human Experimentation. Press Syndicate of the University of Cambridge, Cambridge.
- 53 Medical Research Council (1948). Streptomycin treatment of pulmonary tuberculosis, British Medical Journal 2, 769–782.
- 54
Medical Research Council
(1950).
Clinical trials of antihistaminic drugs in the prevention and treatment of the common cold,
British Medical Journal
ii,
425–431.
10.1136/bmj.2.4676.425 Google Scholar
- 55 Medical Research Council (1952). Chemotherapy of pulmonary tuberculosis in young adults, British Medical Journal i, 1162–1168.
- 56 Medical Research Council (1954). A comparison of cortisone and aspirin in the treatment of early cases of rheumatoid arthritis-I, British Medical Journal i, 1223–1227.
- 57 Medical Research Council (1955). A comparison of cortisone and aspirin in the treatment of early cases of rheumatoid arthritis-II, British Medical Journal ii, 695–700.
- 58 Meier, P. (1975). Statistics and medical experimentation, Biometrics 31, 511–529.
- 59
Meinert, C. L.
(1986).
Clinical Trials. Design, Conduct, and Analysis.
Oxford University Press,
New York.
10.1093/acprof:oso/9780195035681.001.0001 Google Scholar
- 60 Netherlands Minister of Social Affairs and Health (1957). 4 World Medical Journal, 299–300.
- 61 O'Brien, P. C. & Fleming, T. R. (1979). A multiple testing procedure for clinical trials, Biometrics 35, 549–556.
- 62 Osler, W. (1907). The evolution of the idea of experiment, Transactions of the Congress of American Physicians and Surgeons 7, 1–8.
- 63 Packard, F. R. (1921). The Life and Times of Ambroïse Paré, 2nd Ed. Paul B. Hoeber, New York, pp. 27, 163.
- 64 Percival, T. (1803). Medical Ethics. Russell, London.
- 65 Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J. & Smith, P. (1976). Design and analysis of randomized clinical trials requiring prolonged observation of each patient. 1. Introduction and design, British Journal of Cancer 34, 585–612.
- 66 Pocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley, Chichester.
- 67
Pozdena, R. F.
(1905).
Versuche über Blondlot's “Emission Pesante”,
Annalen der Physik
17,
104.
10.1002/andp.19053220606 Google Scholar
- 68 Rheumatic Fever Working Party (1960). The evolution of rheumatic heart disease in children: five-year report of a cooperative clinical trial of ACTH, cortisone, and aspirin, Circulation 22, 505–515.
- 69 Rothman, D. J. (1995). Research, human: historical aspects, in Encyclopedia of Bioethics, W. T. Reich, ed. Free Press, New York, pp. 2258–2261.
- 70 Seabrook, W. (1941). Doctor Wood. Harcourt, Brace & Company, New York, p. 234.
- 71 Shirer, W. L. (1960). The Rise and Fall of the Third Reich. Simon & Schuster, New York.
- 72 Slotki, J. J. (1951). Daniel, Ezra, Nehemia, Hebrew Text and English Translation with Introductions and Commentary. Soncino Press, London.
- 73 Urokinase-Pulmonary Embolism Trial (1973). A National Cooperative Study, A. A. Sasahara, T. M. Cole, F. Ederer, J. A. Murray, N. K. Wenger, S. Sherry & J. M. Stengle, eds. Circulation 47, Supplement 2, pp. 1–108.
- 74 US Government Printing Office (1949). Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2. US Government Printing Office, Washington, pp. 181–182.
- 75 Van Helmont, J. B. (1662). Oriatrike or Physik Refined (translated by J. Chandler). Lodowick Loyd, London.
- 76 Vogt, E. Z. & Hyman, R. (1959). Water Witching, USA. University of Chicago Press, Chicago, p. 50.
- 77 Withington, C. F. (1886). The Relation of Hospitals to Medical Education. Cupples Uphman, Boston.
- 78 Witkosky, S. J. (1889). The Evil That Has Been Said of Doctors: Extracts From Early Writers, Trans. with annotations by T.C. Minor. The Cincinnati Lancet-Clinic, Vol. 41, New Series Vol. 22, pp. 447–448.
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