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Randomised Controlled Clinical Trials

Part of the book series: Developments in Biostatistics and Epidemiology ((DBEP,volume 1))

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References

  1. Bradford Hill, A. The clinical trial. Br. Med. Bull. 7:278–282, 1951.

    Google Scholar 

  2. Cochrane, A.L. Effectiveness and efficiency: Random reflections on health services. London, The Nuffield Provincial Hospital Trust, 1972.

    Google Scholar 

  3. Medical Research Council investigation. Streptomycin treatment of pulmonary tuberculosis. Br. Med. J. 2:769–782, 1948. Material reproduced with permission.

    Article  Google Scholar 

  4. Doll, R., and Peto, R. Randomised controlled trials and retrospective controls: Br. Med. J. 44:280, 1980.

    Google Scholar 

  5. Rose, G. Bias. Br. J. Clin. Pharmacol. 13:157–162, 1982.

    Article  PubMed  CAS  Google Scholar 

  6. L’Etang, J.C. Historical aspects of drug evaluation. In: The principles and practice of clinical trials, Harris, E.L., and Fitzgerald, J.D. (eds.). Edinburgh and London, E. and S. Livingstone, 1970. Pp. 3–6.

    Google Scholar 

  7. Bull, J.P. The historical development of clinical therapeutic trials. J. Chronic Dis. 10:218–248, 1959.

    Article  PubMed  CAS  Google Scholar 

  8. Bradford Hill, A. Statistical methods in clinical and preventive medicine. Edinburgh and London, E. and S. Livingstone, 1962.

    Google Scholar 

  9. Maitland, C. Account of inoculating the smallpox. London, J. Robertson, 1972.

    Google Scholar 

  10. Williams, W. Masters of medicine. London, Pan Books, 1954. P. 23.

    Google Scholar 

  11. Jenner, E. An inquiry into the cause and effects of the variolae vaccinae. London, S. Low, 1798.

    Google Scholar 

  12. Pearson, G. An inquiry concerning the history of cowpox. London, J. Johnson, 1798.

    Google Scholar 

  13. Waterhouse, B. A prospect of exterminating the small pox. Boston, Cambridge, 1800.

    Google Scholar 

  14. Haygarth, J. Of the imagination as a cause and cure of disorders of the body. new ed. Bath, R. Crutwell, 1801. P. 3.

    Google Scholar 

  15. Sutton, H.G. Cases of rheumatic fever treated for the most part by mint water. Guy’s Hosp. Rep. 2:392–428, 1865.

    Google Scholar 

  16. Laplace, P.S. Théorie analytique des probabilités. Paris, 1812.

    Google Scholar 

  17. Louis, P.C.A. Essay on clinical instruction. Translated by Martin P. London, S. Highley, 1834.

    Google Scholar 

  18. Louis, P.C.A. Recherches sur les effects de la saignée. Paris, De Mignaret, 1835.

    Google Scholar 

  19. Bartlett, E. An essay on the philosophy of medical science. Philadelphia, Lea and Blanchard, 1844.

    Google Scholar 

  20. Lister, J. On the effects of the antiseptic system upon the salubrity of a surgical hospital. Lancet 1:4 and 40, 1870.

    Article  Google Scholar 

  21. Pocock, S.J. Randomised controlled trials [letter]. Br. Med. J. 1:1661, 1977.

    Article  PubMed  CAS  Google Scholar 

  22. Vallery-Radot, P. Pasteur 1822–1895. Paris, 1922.

    Google Scholar 

  23. Fibiger, J. Om serumbehandling af Difteri. Hosp. Tid., Kjøbenh 4:6, 309, 337, 1898.

    Google Scholar 

  24. Porrit, A.E., and Mitchell, G.A.G. An investigation into the prophylaxis and treatment of wound infection. In: Penicillin therapy and control in 21 army group. London, 21 Army Group, 1945. P.7.

    Google Scholar 

  25. Amberson, J.B., McMahon, B.T., and Pinner, M. Clinical trials of sanocrysin in pulmonary tuberculosis. Am. Rev. Tuberc. 24:401–435, 1931.

    Google Scholar 

  26. Glaser, E.M. Ethical aspects of clinical trials. In: The principles and practice of clinical trials, Harris E.L. and Fitzgerald, J.D. (eds.), Edinburgh and London, E. and S. Livingstone, 1970.

    Google Scholar 

  27. Wade, O.L. Human experiment 2, clinical aspects. In: Dictionary of medical ethics, Duncan, A.S., Dunstan, G.R., and Welbourn, R.B. (eds.). London, Darton Longman and Todd, 1977.

    Google Scholar 

  28. Mitscherlich A., and Mielke, F. Doctors of infamy: The story of the nazi medical crimes. New York, Shuman, 1949. Pp. xxiii–xxv.

    Google Scholar 

  29. World Medical Association. Human experimentation, code of ethics of the World Medical Association. Declaration of Helsinki. Br. Med. J. 2:177, 1964.

    Article  Google Scholar 

  30. Bradford Hill, A. Medical ethics and controlled trials. Br. Med. J. 1:1043–1049, 1963. Material reproduced with permission of author and editors of Br. Med. J.

    Article  Google Scholar 

  31. Medical Research Council. Responsibility in investigations on human subjects. Br. Med. J. 2:178–180, 1964.

    Article  Google Scholar 

  32. Committee Appointed by the Royal College of Physicians of London: Supervision of the Ethics of Clinical Investigations in Institutes. Br. Med. J. 2:429–430, 1967. Later report published by the college: Report of committee on the supervision of the ethics of clinical investigation in institutions. London, 1973.

    Google Scholar 

  33. Report of a Committee Appointed by Governor Dwight H. Green of Illinois. Ethics governing the service of prisoners as subjects in medical experiments. JAMA 136:457–458, 1948.

    Article  Google Scholar 

  34. Zelen, M. A new design for randomized clinical trials. N. Engl. J. Med. 300:1242–1245, 1979.

    Article  PubMed  CAS  Google Scholar 

  35. Beecher, H.K. Ethics and clinical research. N. Engl. J. Med. 274:1354–1360, 1966.

    Article  PubMed  CAS  Google Scholar 

  36. Beecher, H.K. Pain, placebos and physicians. Practitioner 189:141–155, 1962.

    PubMed  CAS  Google Scholar 

  37. Veterans Administration Co-operative Study Group on Anti-Hypertensive Agents. Effects of treatment on morbidity in hypertension. II Results in patients with diastolic blood pressure averaging 90 through 114 mm Hg. JAMA 213:1143–1152, 1970.

    Article  Google Scholar 

  38. Beecher, H.K. Surgery as placebo: A quantitative study of bias. JAMA 176:1102–1107, 1961. Material reproduced with permission. Copyright 1961, American Medical Association.

    Article  PubMed  CAS  Google Scholar 

  39. Cobb, L.A., et al. An evaluation of internal-mammary-artery ligation by a double-blind technique. N. Engl. J. Med. 260:1115–1118, 1959.

    Article  PubMed  CAS  Google Scholar 

  40. Dimond, E.G., Kittle, C.F., and Crockett, J.E. Evaluation of internal-mammary artery ligation and sham procedure in angina pectoris. Circulation 18:712–713, 1958.

    Google Scholar 

  41. Adams, R. Internal-mammary-ligation for coronary insufficiency: An evaluation. N. Engl. J. Med. 258:113–115, 1958.

    Article  PubMed  CAS  Google Scholar 

  42. Fish, R.C., Grymes, T.P., and Lovell, M.G. Internal-mammary-artery ligation for angina pectoris: Its failure to produce relief. N. Engl. J. Med. 259:418–420, 1958.

    Article  PubMed  CAS  Google Scholar 

  43. Amery, A., et al. Antihypertensive therapy in elderly patients: Pilot trial of the European Working Party on high blood pressure in the elderly. Gerontology 23:426–437, 1977.

    Article  PubMed  CAS  Google Scholar 

  44. McPherson, K. Statistics: The problem of examining accumulating data more than once. N. Engl. J. Med. 290:501–502, 1974.

    Article  PubMed  CAS  Google Scholar 

  45. Coronary Drug Project Research Group: The Coronary Drug Project. JAMA 214:1303–1313, 1970.

    Article  Google Scholar 

  46. University Group Diabetes Program: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. Diabetes 19, suppl. 2:747–830, 1970.

    Google Scholar 

  47. Veterans Administration Co-operative Study Group on Anti-hypertensive Agents: Effects of treatment on morbidity in hypertension. Results in patients with diastolic blood pressure averaging 115 through 129 mm Hg. JAMA 202:1028–1034, 1967.

    Article  Google Scholar 

  48. The Anturane Reinfarction Trial Research Group: Sulfinpyrazone in the prevention of cardiac death after myocardial infarction. N. Engl. J. Med. 298:289–295, 1978.

    Article  Google Scholar 

  49. Bulpitt, C.J., Semmence, A., and Whitehead, T. Blood pressure and biochemical risk factors. Acta Cardiol. 33:109–110, 1978.

    Google Scholar 

  50. Committee of Principal Investigators: A Cooperative trial in the primary prevention of ischaemic heart disease using clofibrate. Br. Heart J. 40:1069–1118, 1978.

    Article  Google Scholar 

  51. Elwood, P.C., et al. A randomised controlled trial of acetyl salicylic acid in the secondary prevention of mortality from myocardial infarction. Br. Med. J. 1:436–440, 1974.

    Article  PubMed  CAS  Google Scholar 

  52. An International Anticoagulant Review Group. Collaborative analysis of long-term anticoagulant administration after acute myocardial infarction. Lancet 1:203–209, 1970.

    Google Scholar 

  53. A progress report of the European Working Party on High Blood Pressure in the Elderly (EWPHE). Cardiac and Renal Function with increasing Age in Elderly Hypertensives. In: Mild hypertension: Natural history and management, Gross, F. and Strasser, T. (eds.). Tunbridge Wells, Pitman Medical, 1979. Pp. 181–197.

    Google Scholar 

  54. Amery, A., et al. Glucose intolerance during diuretic therapy: Results of trial by the European Working party on Hypertension in the Elderly. Lancet 1:681–683, 1978.

    Article  PubMed  CAS  Google Scholar 

  55. Fowler, F.G. and Fowler, H.W. The Pocket Oxford Dictionary of Current English, SR ed. Oxford Clarendon Press, 1969.

    Google Scholar 

  56. Rose, G., and Hamilton, P.J.S. A randomised controlled trial of the effect on middle-aged men of advice to stop smoking. J. Epidemiol. Community Health 32:275–281, 1978.

    Article  PubMed  CAS  Google Scholar 

  57. Veterans Administration Co-operative Study Group on Antihypertensive Agents. Effects of treatment on morbidity in hypertension: II. Influence of age, diastolic pressure, and prior cardiovascular disease: Further analysis of side effects. Circulation 45:991–1004, 1972.

    Article  Google Scholar 

  58. Hypertension Detection and Follow-up Program Cooperative Group. Five-year findings of the hypertension detection and follow-up program: II. Mortality by race, sex, and age. JAMA 242:2572–2577, 1979.

    Article  Google Scholar 

  59. Meier, P. Terminating a trial—The ethical problem. Clin. Pharmacol. Ther. 25:633–640, 1979.

    PubMed  CAS  Google Scholar 

  60. Stamler, J. When and how to stop a clinical trial: Invited remarks. Clin. Pharmacol. Ther. 25:651–654, 1979.

    PubMed  CAS  Google Scholar 

  61. Benedict, G.W. LRC Coronary Prevention Trial: Baltimore. Clin. Pharmacol. Ther. 25, 685–687, 1979.

    PubMed  CAS  Google Scholar 

  62. Schoenberger, J.A. Recruitment to the Coronary Drug Project and the Aspirin Myocardial Infarction Study. Clin. Pharmacol. Ther. 25:681–684, 1979.

    PubMed  CAS  Google Scholar 

  63. Croke, G. Recruitment for the National Co-operative Gallstone study. Clin. Pharmacol. Ther. 25:691–694, 1979.

    PubMed  CAS  Google Scholar 

  64. Prout, T.E. Patient recruitment: Other examples of recruitment and solutions. Clin. Pharmacol. Ther. 25:695–696, 1979.

    PubMed  CAS  Google Scholar 

  65. Zelen, M. The randomisation and stratification of patients to clinical trials. J. Chron. Dis. 27:365–375, 1974.

    Article  PubMed  CAS  Google Scholar 

  66. Wright, I.S., Marple, C.D., and Beck, D.F. Myocardial Infarction. Its clinical manifestation and treatment with anticoagulants. New York, Grune and Stratton, 1954. Pp. 8–10.

    Google Scholar 

  67. Weinstein, M.C. Allocation of subjects in medical experiments. N. Engl. J. Med. 291:1278–1285, 1974. Material reproduced with permission.

    Article  PubMed  CAS  Google Scholar 

  68. Ederer, F. Patient bias, investigator bias and the double-masked procedure in clinical trials. Aw. J. Med. 58:295–299, 1975.

    Article  CAS  Google Scholar 

  69. Peto, R. Clinical trial methodology. Biomedicine Special No: 24-36, 1978.

    Google Scholar 

  70. Peto, R., et al. Design and analysis of randomised clinical trial requiring prolonged observation of each patient. I. Introduction and design. Br. J. Cancer 34:585–612, 1976.

    Article  PubMed  CAS  Google Scholar 

  71. Roethlisberges, F.G., and Dickson, W.J. Management and the worker. An account of a research program conducted by the Western Electric Company, Hawthorne Works, Chicago. Cambridge, Mass., Harvard University Press, 1946.

    Google Scholar 

  72. Beecher, H.K. The powerful placebo. JAMA 159:1602–1606, 1955.

    Article  CAS  Google Scholar 

  73. Keats, A.S., Beecher, H.K., and Mosteller, F.C. Measurement of pathological pain in distinction to experimental pain. J. Appl. Physiol. 3:34–44, 1950.

    Google Scholar 

  74. Keats, A.S., D’Alessandro, G.L. and Beecher, H.K. Report to the council on pharmacy and chemistry. JAMA 147:1761–1776, 1951.

    Article  CAS  Google Scholar 

  75. Beecher, H.K., et al. Field use of methodone and levo-iso-methadone in a combat zone. U.S. Armed Forces Med. J. 2:1269–1276, 1951.

    PubMed  CAS  Google Scholar 

  76. Lasagne, L., et al. Study of placebo response. Am. J. Med. 16:770–779, 1954.

    Article  Google Scholar 

  77. Beecher, H.K., et al. Effectiveness of oral analgesics (morphine, codeine, acetylsalicylic acid) and problem of placebo ‘reactors’ and ‘non reactors’. J. Pharmacol. Exp. Ther. 109:393–400, 1953.

    PubMed  CAS  Google Scholar 

  78. Travell, J., et al. Comparison of effects of alpha-tocopherol and matching placebo on chest pain in patients with heart disease. Ann. N.Y. Acad. Sci. 52:345–353, 1949.

    Google Scholar 

  79. Evans, W., and Hoyle, C. Comparative value of drugs used in continuous treatment of angina pectoris. Q. J. Med. 2:311–338, 1933.

    Google Scholar 

  80. Greiner, T., et al. Method for evaluation of effects of drugs on cardiac pain in patients with angina of effort; study of khellin (visamin). Am. J. Med. 9:143–155, 1950.

    Article  PubMed  CAS  Google Scholar 

  81. Bulpitt, C.J. Heparin as an analgesic in myocardial infarction. A double-blind trial. Br. Med. J. 3:279–281, 1967.

    Article  PubMed  CAS  Google Scholar 

  82. Jellinek, E.M. Clinical tests on comparative effectiveness of analgesic drugs. Biomet. Bull. 2:87–91, 1946.

    Article  CAS  Google Scholar 

  83. Gravenstein, J.S., Devloo, R.A., and Beecher, H.K. Effect of antitussive agents on experimental and pathological cough in man. J. Appl. Physiol. 7:119–139, 1954.

    PubMed  CAS  Google Scholar 

  84. Hillis, B.R. The assessment of cough-suppressing drugs. Lancet 1:1230–1235, 1952.

    Article  PubMed  CAS  Google Scholar 

  85. Shapiro, A.K. Factors contributing to the placebo effect. Their implications for psychotherapy. Am. J. Psychother. 18:suppl. 1, 73–88, 1964.

    PubMed  Google Scholar 

  86. Dollery, C.T. A bleak outlook for placebos (and for science). Eur. J. Clin. Pharmacol. 15:219–221, 1979.

    Article  PubMed  CAS  Google Scholar 

  87. Byar, D.P., et al. Randomised clinical trials. Perspectives on some recent ideas. N. Engl. J. Med. 295:74–80, 1976.

    Article  PubMed  CAS  Google Scholar 

  88. Christie, D. Before-and-after comparisons: a cautionary role. Br. Med. J. 2:1629–1630, 1979.

    Article  PubMed  CAS  Google Scholar 

  89. Doll, R., and Peto, R. Mortality in relation to smoking: 20 years’ observation on male British doctors. Br. Med. J. 2:1525–1536, 1976.

    Article  PubMed  CAS  Google Scholar 

  90. Ballintine, E.J. Randomized controlled clinical trial. National Eye Institute workshop for ophthalmologists. Objective measurements and the double-masked procedure. Am. J. Ophthalmol. 79:763–767, 1975.

    PubMed  CAS  Google Scholar 

  91. Pozdena, R.F. Versuche über Blondlots ‘Emission Pesante’. Ann Physik. 17:104, 1905.

    Article  Google Scholar 

  92. Seabrook, W. Doctor Wood. New York, Harcourt, Brace, 1941. P. 234.

    Google Scholar 

  93. Fletcher, C.M. Criteria for diagnosis and assessment in clinical trials. In: Controlled clinical trials, Hill, A.B. (ed.). Springfield, 111., Charles C. Thomas, 1960.

    Google Scholar 

  94. Kahn, H.A., et al. Serum cholesterol: its distribution and association with dietary and other variables in a survey of 10,000 men. Isr. J. Med. Sci. 5:1117–1127, 1969.

    PubMed  CAS  Google Scholar 

  95. Wilson, E.B. An introduction to scientific research. New York, McGraw-Hill, 1952.

    Google Scholar 

  96. Bearman, J.E., Loewenson, R.B., and Gullen, W.H. Muench’s postulates, laws, and corollaries or Biometricians’ views on clinical studies. Biometrics note 4, National Eye Institute, Bethesda, Md., 1974.

    Google Scholar 

  97. Foulds, G.A. Clinical research in psychiatry. J. Ment. Sci. 104:259, 1958.

    PubMed  CAS  Google Scholar 

  98. Report of a co-operative randomised controlled trial. Control of moderately raised blood pressure. Br. Med. J. 3:434–436, 1973. Material reproduced with permission.

    Article  Google Scholar 

  99. Knowelden, J. In: Prophylactic trials, medical surveys and clinical trials, Witts, L.J. (ed.). London, Oxford University Press, 1959.

    Google Scholar 

  100. National Diet-Heart Study Research Group. The National Diet-Heart Study. Circulation 37, suppl. 1:1253–1259, 1968.

    Google Scholar 

  101. Pearson, R.M., Bulpitt, C.J., and Havard, C.W.H. Biochemical and haematological changes induced by tienilic acid combined with propranolol in essential hypertension. Lancet 1:697–699, 1979.

    Article  PubMed  CAS  Google Scholar 

  102. U.S. Department of Health, Education and Welfare. National Institutes of Health. Cold study reveals some vitamin C influence; more research needed. Bethesda, Md. NIH Record 25:4, 197

    Google Scholar 

  103. Heaton-Ward, W.A. Influence and suggestion in a clinical trial (Niamid in mongolism). J. Ment. Sci. 108:865–870, 1962.

    Google Scholar 

  104. Abraham, H.C., et al. A controlled clinical trial of imipramine (Tofranil) with outpatients. Br. J. Psychiatry 109:286–293, 1963.

    Article  PubMed  CAS  Google Scholar 

  105. Report to the Medical Research Council by its clinical psychiatry committee: Clinical trial of the treatment of depressive illness. Br. Med. J. 1:881–886, 1965.

    Article  Google Scholar 

  106. Report of Medical Research Council Working Party on Mild to Moderate Hypertension. Randomised controlled trial of treatment for mild hypertension: design and pilot trial. Br. Med. J. 1:1437–1440, 1977.

    Article  Google Scholar 

  107. Report by the Mangement Committee. Initial results of the Australian Therapeutic Trial in mild hypertension. Clin. Sci. 57:449s–452s, 1979.

    Google Scholar 

  108. Cooper, G.R. The World Health Organization Centre for Disease Control Lipid Standardization Program. In: Quality control in chemistry. Berlin, Walter de Gruyter and Co., 1976. Pp. 97–105.

    Google Scholar 

  109. Rogot, E., and Goldberg, I.D. A proposed index for measuring agreement in test-retest studies. J. Chron. Dis. 19:991–1006, 1966.

    Article  PubMed  CAS  Google Scholar 

  110. Bulpitt, C.J., Dollery, C.T., and Carne, S. Change in symptoms of hypertensive patients on referral to hospital clinic. Br. Heart J. 38:121–128, 1976.

    Article  PubMed  CAS  Google Scholar 

  111. Galton, F. Regression towards mediocrity in hereditary stature. J. Anthropological Inst. 15:246–263, 1886.

    Google Scholar 

  112. Ferris, F.L., and Ederer, F. External monitoring in multiclinic trials: Application from ophthalmologic studies. Clin. Pharmacol. Ther. 25:720–723, 1979.

    PubMed  CAS  Google Scholar 

  113. Wright, B.M., and Dore, C.F. A random-zero sphygmomanometer. Lancet 1:337–338, 1970.

    PubMed  CAS  Google Scholar 

  114. Rose, G.A., Holland, W.W., and Crowley, F.A. A sphygmomanometer for epidemiologists. Lancet 1:296–300, 1964.

    Article  PubMed  CAS  Google Scholar 

  115. Kahn, H.A., et al. Standardising diagnostic procedures. Am. J. Ophthalmol. 79:768–775, 1975.

    PubMed  CAS  Google Scholar 

  116. Williams, O.D. A framework for the quality assurance of clinical data. Clin. Pharmacol. Ther. 25:700–702, 1979.

    PubMed  CAS  Google Scholar 

  117. Schwartz, D., Flamant, R., and Lellouch, J. Clinical trials. Translated by M.J.R. Healy. London, Academic Press, 1980. Pp. 29-33.

    Google Scholar 

  118. Hamilton, M., Thompson, E.M., and Wisniewski, T.K. The role of blood pressure control in preventing complications of hypertension. Lancet 1:235–238, 1964.

    Article  PubMed  CAS  Google Scholar 

  119. Clark, C.J. and Downie, C.C. A method for the rapid determination of the number of patients to include in a controlled clinical trial. Lancet 2:1357–1358, 1966.

    Article  PubMed  CAS  Google Scholar 

  120. Coronary Drug Project Research Group. The Coronary Drug Project: Design, methods and baseline results. Circulation 47 and 48, suppl. 1:12–137, 1973.

    Google Scholar 

  121. National Diet-Heart Study Report. Appendix Aa-c. Sample size estimates for medical trials. Circulation 37 and 38, suppl.:1279–1308, 1968.

    Google Scholar 

  122. Rose, G.A. Beta-blockers in immediate treatment of myocardial infarction. Br. Med. J. 280:1088, 1980.

    Article  PubMed  CAS  Google Scholar 

  123. Baber, N.S., and Lewis, J.A. Beta-blockers in the treatment of myocardial infarction (letter). Br. Med. J. 3:59, 1980.

    Article  Google Scholar 

  124. Schwartz, D., and Lellouch, J. Explanatory and pragmatic attitudes in therapeutical trials. J. Chron. Dis. 20:637–648, 1967.

    Article  PubMed  CAS  Google Scholar 

  125. Halperin, M., et al. Sample sizes for medical trials with special reference to long-term therapy. J. Chron. Dis. 21:13–24, 1968.

    Article  PubMed  CAS  Google Scholar 

  126. George, S.L., and Desu, M.M. Planning the size and duration of a clinical trial studying the time to some critical event. J. Chron. Dis. 27:15–24, 1974.

    Article  PubMed  CAS  Google Scholar 

  127. Sondik, E.J., Brown, B.W., and Silvers, A. High risk subjects and the cost of large field trials. J. Chron. Dis. 27:177–187, 1974.

    Article  PubMed  CAS  Google Scholar 

  128. Cochran, W.G. Sampling techniques. New York: Wiley, 1963. P. 145.

    Google Scholar 

  129. Nam, J.M. Optimum sample sizes for the comparison of the control and treatment. Biometrics 29:101–108, 1973.

    Article  PubMed  CAS  Google Scholar 

  130. Gail, M., et al. How many controls? J. Chron. Dis. 29:723–731, 1976.

    Article  PubMed  CAS  Google Scholar 

  131. Dunnett, C.W. Multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 50:1096, 1955.

    Article  Google Scholar 

  132. Hypertension Detection and Follow-up Program Cooperative Group. Five-year findings of the hypertension detection and follow-up program. 1. Reduction in mortality of persons with high blood pressure including mild hypertension. JAMA 242:2562–2571, 1979.

    Article  Google Scholar 

  133. Hills, M., and Armitage, P. The two-period cross-over clinical trial. Br. J. Clin. Pharmacol. 8:7–20, 1979.

    Article  PubMed  CAS  Google Scholar 

  134. Meier, P., and Free, S.M. Further consideration of methodology in studies of pain relief. Biometrics 27:576–583, 1961.

    Article  Google Scholar 

  135. Fisher, R.A. In: The design of experiments. Edinburgh, Oliver and Boyd, 1947.

    Google Scholar 

  136. Wilson, C., Pollock, M.R., and Harris, A.D. Diet in the treatment of infective hepatitis. Therapeutic trial of cysteine and variation of fat-content. Lancet 1:881–883, 1946.

    Article  PubMed  CAS  Google Scholar 

  137. Aenishänslin, W., et al. Antihypertensive therapy with adrenergic beta-receptor blockers and vasodilators. Eur. J. Clin. Pharmacol. 4:177–181, 1972.

    Article  PubMed  Google Scholar 

  138. Pearson, R.M., et al. Trial of combination of guanethidine and oxprenolol in hypertension. Br. Med. J. 1:933–936, 1976.

    Article  PubMed  CAS  Google Scholar 

  139. Chalmers, J., et al. Effects of timolol and hydrochlorothiazide on blood-pressure and plasma renin activity. Double-blind factorial trial. Lancet 2:328–331, 1976.

    Article  PubMed  CAS  Google Scholar 

  140. Lynch, P., et al. Objective assessment of anti-anginal treatment: a double-blind comparison of propranolol, nifedipine and their combination. Br. Med. J. 1:184–187, 1980.

    Article  Google Scholar 

  141. Williams, E.F. Experimental designs balanced for the estimation of residual effects of treatments. Aust. J. Sci. Res. Assoc. 2:149–168, 1949.

    Google Scholar 

  142. Cochran, W.G., and Cox, G.M. In: Experimental designs, 2nd ed. New York, Wiley & Sons, 1957. P. 133.

    Google Scholar 

  143. Armitage, P. Sequential medical trials. Oxford, Blackwell Scientific Publications, 1960.

    Google Scholar 

  144. Wald, A. Sequential analysis. New York, Wiley, 1947.

    Google Scholar 

  145. Robertson, J.D., and Armitage, P. Comparison of two hypotensive agents. Anaesthesia 14:53–64, 1959.

    Article  PubMed  CAS  Google Scholar 

  146. Snell, E.S., and Armitage, P. Clinical comparison of diamorphine and pholcodine as cough suppressants, by a new method of sequential analysis. Lancet 1:860–862, 1957.

    Article  Google Scholar 

  147. Anscombe, F.J. Fixed sample-size analysis of sequential observations. Biometrics 10:98–100, 1954.

    Article  Google Scholar 

  148. Cochran, W.G. Newer statistical methods. In: Quantitated methods in human pharmacology and therapeutics, Lawrence, D.R. (ed.). London, Pergamon, 1959. Pp. 119–143.

    Google Scholar 

  149. Zelen, M. Play the winner rule and the controlled clinical trial. J. Am. Stat. Assoc. 64:131–146, 1969.

    Article  Google Scholar 

  150. Meier, P. Terminating a trial—the ethical problem. Clin. Pharmacol. Ther. 25:633–640, 1979.

    PubMed  CAS  Google Scholar 

  151. Chalmers, T.C. When and how to stop a clinical trial: Invited remarks. Clin. Pharmacol. Ther. 25:649–650, 1979.

    PubMed  CAS  Google Scholar 

  152. Hill, C., and Sancho-Garnier, H. The two-armed bandit problem, a decision theory approach to clinical trials. Biomedicine 28 42–43, 1978.

    PubMed  Google Scholar 

  153. Bearman, J.E. Randomized controlled clinical trial. National Eye Institute Workshop for Ophthalmologists. Writing the protocol for a clinical trial. Am. J. Ophthalmol. 79:775–778, 1975.

    PubMed  CAS  Google Scholar 

  154. McFate Smith, W. Problems in long-term trials. In: Mild hypertension: Natural history and management. Gross, F. and Strasser, T. (eds.). Pitman Medical. Tunbridge Wells, England, 1979. Pp. 244–255.

    Google Scholar 

  155. Spriet, A., and Simon, P. Questions à se poser pour vérifier un protocole d’essai thérapeutique avant d’en entreprendre l’exécution. Thérapie 32:633–642, 1977.

    PubMed  CAS  Google Scholar 

  156. Clinical Trials Unit, Department of Pharmacology and Therapeutics, London Hospital Medical College. Aide-mémoire for preparing clinical trial protocols. Br. Med. J. 1:1323–1324,1977.

    Google Scholar 

  157. Hamilton, M. Computer programmes for the medical man: A solution. Br. Med. J. 2:1048–1050, 1965.

    Article  PubMed  CAS  Google Scholar 

  158. Wright, P., and Haybittle, J. Design of forms for clinical trials (1), (2) and (3). Br. Med. J. 2:529–530, 590-592, 650-651, 1979.

    Article  PubMed  CAS  Google Scholar 

  159. Bulpitt, C.J., Dollery, C.T., and Carne, S. A symptom questionnaire for hypertensive patients. J. Chron. Dis. 27:309–323, 1974.

    Article  PubMed  CAS  Google Scholar 

  160. Nicholls, D.P., et al. Comparison of labetalol and propranolol in hypertension. Br. J. CLin. Pharmacol. 9:233–237, 1980.

    Article  PubMed  CAS  Google Scholar 

  161. Survey Control Unit. Central Statistical Office. Ask a silly question. Government Statistical Service HMSO, 1976.

    Google Scholar 

  162. Bennett, A.E., and Ritchie, K. Questionnaires in medicine: A guide to their design and use. Oxford: Nuff, Prov. Hosp. Trust. 1975.

    Google Scholar 

  163. Tinker, M.A. In: Bases for effective reading. Minneapolis, Minnesota Press, 1965.

    Google Scholar 

  164. Clark, H.H. Psychol. Rev. 76:387, 1969.

    Article  Google Scholar 

  165. International nonproprietary names (INN) for pharmaceutical substances: WHO, 1976.

    Google Scholar 

  166. Bulpitt, C.J., et al. The symptom patterns of treated diabetic patients. J. Chron. Dis. 29:571–583, 1976.

    Article  PubMed  CAS  Google Scholar 

  167. Bloch, A. Murphy’s law and other reasons why things go wrong. London, Magnum books, Methuen Paperbacks, 1979.

    Google Scholar 

  168. Amery, A., et al. Antihypertensive therapy in patients above age 60: Third interim report of the European Working Party on High Blood Pressure in Elderly (EWPHE). Acta Cardiol. 33:113–134, 1978.

    PubMed  CAS  Google Scholar 

  169. Hampton, J.R. Presentation and analysis of the results of clinical trials in cardiovascular disease. Br. Med. J. 282:1371–1373, 1981.

    Article  CAS  Google Scholar 

  170. Norwegian Multicentre Study Group. Timolol-induced reduction in mortality and rein-farction in patients surviving acute myocardial infarction. N. Engl. J. Med. 301:801–807, 1981.

    Google Scholar 

  171. Wilkinson, G.N. Estimation of missing values for the analysis of incomplete data. Biometrics 14:257–286, 1958.

    Article  Google Scholar 

  172. Gordis, L. Conceptual and methodologic problems in measuring patient compliance. In: Compliance in health care, Haynes, R.L., Taylor, R.W., and Sackett, D.L. (eds.). Baltimore and London, John Hopkins University Press, 1979. Pp. 23–65.

    Google Scholar 

  173. Sackett, D.L. A compliance practical for the busy practitioner. In: Compliance in health care, Haynes, R.L., Taylor, R.W., and Sackett, D.L. (eds.). Baltimore and London, John Hopkins University Press, 1979. Pp. 286–294.

    Google Scholar 

  174. Feinstein, A.R., et al. A controlled study of three methods of prophylaxis against streptococcal infection in a population of rheumatic children. II. Results of the first three years of the study, including methods for evaluating the maintenance of oral prophylaxis. N. Engl. J. Med. 260:697–702, 1959.

    Article  PubMed  CAS  Google Scholar 

  175. Park. L.C., and Lipman, R.S. A comparison of patient dosage deviation reports with pill counts. Psychoparmacologie 6:299–302, 1964.

    Article  CAS  Google Scholar 

  176. Gordis, L., Markowitz, M., and Lilienfeld, A.M. The inaccuracy in using interviews to estimate patient reliability in taking medications at home. Med. Care 7:49–54, 1969.

    Article  PubMed  CAS  Google Scholar 

  177. Bulpitt, C.J., Clifton, P., and Hoffbrand, B.I. Factors influencing over and underconsumption of anti-hypertensive drugs. Acta Int. Pharmacodyn Ther. suppl.:243–250, 1980.

    CAS  Google Scholar 

  178. Mushlin, A.I., and Appel, F. A. Diagnosing potential noncompliance. Physicians’ ability in a behavioural dimension of medical care. Arch. Intern. Med. 137:318–321, 1977.

    Article  PubMed  CAS  Google Scholar 

  179. Roth, H.P., Caron, H.S., and Hsi, B.P. Measuring intake of a prescribed medication: A bottle count and a tracer technique compared. Clin. Pharmacol. Ther. 11:288–337, 1970.

    Google Scholar 

  180. Bergman, A.B., and Werner, R.J. Failure of children to receive penicillin by mouth. N. Engl. J. Med. 268:1334–1338, 1963.

    Article  PubMed  CAS  Google Scholar 

  181. Goldsmith, C.H. The effect of compliance distributors on therapeutic trial. In: Compliance in health care, Haynes, R.L., Taylor, R.W., and Sackett, D.L. (eds.). Baltimore and London, John Hopkins University Press, 1979. Pp. 297–308.

    Google Scholar 

  182. Feinstein, A.R. Biostatistical problems in ‘compliance bias’. Clin. Pharmacol. Ther. 16:846–857, 1974.

    PubMed  CAS  Google Scholar 

  183. Schor, S., and Karten, I. Statistical evaluation of medical journal manuscripts. JAMA 195:1123–1128, 1966.

    Article  PubMed  CAS  Google Scholar 

  184. Schoolman, H.M., et al. Statistics in medical research: principles versus practices. J. Lab. Clin. Med. 7:357–367, 1968.

    Google Scholar 

  185. Lionel, N.D.W., and Herxheimer, A. Assessing reports of therapeutic trials. Br. Med. J. 3:637–640, 1970.

    Article  PubMed  CAS  Google Scholar 

  186. Gore, S.M., Jones, I.G., and Rytter, E.C. Misuse of statistical methods: critical assessment of articles in B.M.J. from January to March 1976. Br. Med. J. 1:85–87, 1977.

    Article  PubMed  CAS  Google Scholar 

  187. Freiman, J.A., et al. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 ‘negative’ trials. N. Engl. J. Med. 299:690–694, 1978.

    Article  PubMed  CAS  Google Scholar 

  188. Glantz, S.A. Biostatistics: How to detect, correct and prevent errors in the medical literature. Circulation 61:1–7, 1980.

    Article  PubMed  CAS  Google Scholar 

  189. Armitage, P. Statistical methods in medical research. Oxford and Edinburgh, Blackwell Scientific, 1971.

    Google Scholar 

  190. Snedecor, G.W., and Cochran, W.G. Statistical methods. Ames, Iowa, Iowa State University Press, 1967.

    Google Scholar 

  191. Petrie, A. Lecture notes on medical statistics. Oxford and Edinburgh, Blackwell Scientific, 1978.

    Google Scholar 

  192. Peto, R., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II: Analysis and examples. Br. J. Cancer 35:1–39, 1977.

    Article  PubMed  CAS  Google Scholar 

  193. Hogben, L., and Sim, M. The self-controlled and self-recorded clinical trial for low-grade morbidity. Br. J. Prev. Soc. Med. 7:163–179, 1953.

    PubMed  CAS  Google Scholar 

  194. Bulpitt, C.J. The design of clinical trials. Br. J. Hosp. Med. 13:611–620, 1975.

    Google Scholar 

  195. Feinstein, A.R. Clinical biostatistics. A survey of the statistical procedures in general medical journals. Clin. Pharmacol. Ther. 15:97–107, 1974.

    PubMed  CAS  Google Scholar 

  196. Zar, J.H. In: Biostatistical analysis. Englewood Cliffs, N.J., Prentice-Hall, 1974. Pp. 130–131.

    Google Scholar 

  197. Nie, N.N., et al. Statistical package for the social sciences. New York, McGraw-Hill, 1975.

    Google Scholar 

  198. Healy, M.J.R., and Whitehead, T.P. Outlying values in the national quality control scheme. Ann. Clin. Biochem. 17:78–81, 1980.

    PubMed  CAS  Google Scholar 

  199. Barnett, V. The study of outliers: Purpose and model. Appl. Stat. 27:242–250, 1978.

    Article  Google Scholar 

  200. John, J.A. Outliers in factorial experiments. Appl. Stat. 27:111–119, 1978.

    Article  Google Scholar 

  201. Sprackling, M.E., et al. Blood pressure reduction in the elderly: a randomised controlled trial of methyldopa. Br. Med. J. 283:1151–1153, 1981.

    Article  CAS  Google Scholar 

  202. Mantel, N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother. Rep. 50:163–170, 1966.

    PubMed  CAS  Google Scholar 

  203. Breslow, N.E. Analysis of survival data under the proportional hazards model. Int. Stat. Rev. 43:45–57, 1975.

    Article  Google Scholar 

  204. Wulff, H.R. Letter: Confidence limits in evaluating controlled therapeutic trials. Lancet 2:969–970, 1973.

    Article  PubMed  CAS  Google Scholar 

  205. Leading article. Interpreting clinical trials. Br. Med. J. 2:1318, 1978.

    Google Scholar 

  206. Baber, N.S., and Lewis, J.A. Beta-blockers in treatment of myocardial infarction. Br. Med. J. 2:59, 1980.

    Article  Google Scholar 

  207. Gore, S.M. Statistics in question: Assessing methods—confidence intervals. Br. Med. J. 283:660–662, 1981.

    Article  CAS  Google Scholar 

  208. Ederer, F. A parametric estimate of the standard error of the survival rate. J. Am. Stat. Assoc. 56:111–118, 1961.

    Article  Google Scholar 

  209. Cox, D.R. Regression models and life tables. J. R. Stat. Soc. Br. 34:187–202, 1972.

    Google Scholar 

  210. McMichael, J. Anticoagulants: Another view. Br. Med. J. 2:1007, 1964.

    Article  PubMed  CAS  Google Scholar 

  211. Hypertension Detection and Follow-up Program Cooperative Group. Five-year findings of the hypertension detection and follow-up program. II. Mortality by race-sex and age. JAMA 242:2572–2577, 1979.

    Article  Google Scholar 

  212. Amery, A., et al. Hypotensive action and side effects of clonidine-chlorthalidone and methyldopa-chlorthalidone in treatment of hypertension. Br. Med. J. 4:392–395, 1970.

    Article  PubMed  CAS  Google Scholar 

  213. McMahon, F.G. Efficacy of an antihypertensive agent. Comparison of methyldopa and hydrochlorothiazide in combination and singly. JAMA 231:155–158, 1975.

    Article  PubMed  CAS  Google Scholar 

  214. Gibb, W.E., et al. Comparison of bethanidine, alpha-methyldopa and reserpine in essential hypertension. Lancet 2:275–277, 1970.

    Article  PubMed  CAS  Google Scholar 

  215. Hefferman, A., et al. A within-patient comparison of debrisoquine and methyldopa in hypertension. Br. Med. J. 1:75–78, 1971.

    Article  Google Scholar 

  216. Conolly, M.E., et al. A crossover comparison of clonidine and methyldopa in hypertension. Eur. J. Clin. Pharmacol. 4:222–227, 1972.

    Article  Google Scholar 

  217. Oates, J. A., et al. The relative efficacy of guanethidine, methyldopa and pargyline as antihypertensive agents. N. Engl. J. Med. 273:729–734, 1965.

    Article  PubMed  CAS  Google Scholar 

  218. Prichard, B.N.C., et al. Bethanidine, guanethidine and methyldopa in treatment of hypertension: A within patient comparison. Br. Med. J. 1:135–144, 1968.

    Article  PubMed  CAS  Google Scholar 

  219. Schooler, K.K. A study of errors and bias in coding responses to open end questions. Dissertation Abstr. 16:2542, 1956.

    Google Scholar 

  220. Young, D.W. Evaluation of a questionary. Methods Inf. Med. 11:15–19, 1972.

    PubMed  CAS  Google Scholar 

  221. Collen, M.F., et al. Reliability of a self-administered medical questionnaire. Arch. Intern. Med. 123:664–681, 1969.

    Article  PubMed  CAS  Google Scholar 

  222. Rose, G.A. The diagnosis of ischaemic heart pain and intermittent claudication in field surveys. Bull. WHO 27:645–658, 1962.

    PubMed  CAS  Google Scholar 

  223. Maccoby, E.E., and Maccoby, N. The interview: A tool of social science. In: Handbook of social pychology, Lindzey, G. (ed.). Reading, Mass., Addison-Wesley, 1954.

    Google Scholar 

  224. Mellner, C. The self-administered medical history. Theoretical possibilities and practical limitations of the usefulness of standardized medical histories. Acta Chir Scand. Suppl. 406:1+, 1970.

    Google Scholar 

  225. Belson, W., and Duncan, J.A. A comparison of the check-list and the open response questioning systems. Appl. Stat. 11:120–132, 1962.

    Article  Google Scholar 

  226. Cannel, C.F., and Kahn, R.L. The collection of data by interviewing. In: Research Methods in Behavioral Sciences, Festinger, L., and Katz, D. (eds.). New York, Dryden, 1953.

    Google Scholar 

  227. Cronbach, L.J. Further evidence on response sets and test design. Educ. Psych. Meas. 10:3, 1950.

    Google Scholar 

  228. Anderson, J., and Day, J.L. New self-administered medical questionary. Br. Med. J. 4:636–638, 1968.

    Article  PubMed  CAS  Google Scholar 

  229. Anastasi, A. In: Psychological testing. New York, Macmillan, 1961.

    Google Scholar 

  230. Parten, M.B. In: Surveys, polls and samples. New York, Harper, 1950.

    Google Scholar 

  231. Shepherd, M. Implications of a multi-centred clinical trial of treatment of depressive illness. In: Anti-depressant drugs, Garattini, S., and Dukes, M.N.G. (eds.). Amsterdam, Excerpta Medica, 1967. P. 332.

    Google Scholar 

  232. Hamilton, M. Evaluation of psychotropic drugs (3) sedatives. In: Principles and practice of clinical trials, Harris, E.L., Fitzgerald, J.D., (eds.). Edinburgh and London, E. and S. Livingston, 1970. Pp. 217–225.

    Google Scholar 

  233. Eysenck, H.J. Manual of the Maudsley personality inventory. London: University of London Press, 1959.

    Google Scholar 

  234. Taylor, J.A. A personality scale of manifest anxiety: J. Abnorm. Soc. Psychol. 48:285, 1953.

    Article  CAS  Google Scholar 

  235. Overall, J.E., and Gorham, G.R. The brief psychiatric rating scale. Psychol. Rep. 10:799, 1962.

    Article  Google Scholar 

  236. Kellner, R., and Sheffield, B.F. The use of self-rating in a single-patient multiple cross-over trial. Br. J. Psychiat. 114:193–196, 1968.

    Article  CAS  Google Scholar 

  237. Hamilton, M. The assessment of anxiety states by rating. Br. J. Med. Psychol. 32:50, 1959.

    Article  PubMed  CAS  Google Scholar 

  238. Shepherd, M. Evaluation of psychotropic drugs. In: Principles and practice of clinical trials. Harris, E.L., and Fitzgerald, J.D. (eds.). Edinburgh and London, E. and S. Livingston, 1970. Pp. 208–216.

    Google Scholar 

  239. Bulpitt, C.J. Quality of life in hypertensive patients. In: Hypertensive cardiovascular disease: Pathophysiology and treatment, Amery, A. et al. (eds.). The Hague, Martinus Nijhoff, 1982.

    Google Scholar 

  240. Bulpitt, C.J., Dollery, C.T., and Hoffbrand, B.I. The contribution of psychological features to the symptoms of treated hypertensive patients. Psychol. Med. 77:661–665, 1977.

    Article  Google Scholar 

  241. Bulpitt, C.J., et al. The symptom patterns of treated diabetic patients. J. Chron. Dis. 29:571–583, 1976.

    Article  PubMed  CAS  Google Scholar 

  242. Fanshel, S., and Bush, J.W. A health status index and its application to health services outcomes. Operations Res. 18:1021–1065, 1970.

    Article  Google Scholar 

  243. Greenwood, D.T., and Todd, A.H. From laboratory to clinical use. In: Clinical trials. Johnson, F.N., and Johnson, S. (eds.). Oxford, Blackwell Scientific Publications, 1977, Pp. 13–35.

    Google Scholar 

  244. Simon, T.R.M., and Jones, G. Safety of medicines: The control of clinical trials. In: Clinical trials. Johnson, F.N., and Johnson, S. (eds.). Oxford, Blackwell Scientific Publications, 1977. Pp. 1–2.

    Google Scholar 

  245. Griffin, J.P., and Long, J.R. New procedure affecting the conduct of clinical trials in the United Kingdom. Br. Med. J. 283:477–478, 1981.

    Article  CAS  Google Scholar 

  246. Dollery, C.T. Clinical trials of new drugs. J. Roy. Coll. Phys. 11:226–233, 1977.

    CAS  Google Scholar 

  247. Lumbroso, A. The introduction of new drugs. In: Pharmaceuticals and health policy, Blum, R., et al. (eds.). London, Croom Helm, 1981.

    Google Scholar 

  248. Crout, J.R. Quoted in Lumbroso, A. The introduction of new drugs. In: Pharmaceuticals and health policy, Blum, R., et al. (eds.). London, Croom Helm, 1981.

    Google Scholar 

  249. Silverman, M., and Lydecker, M. The promotion of prescription drugs and other puzzles. In: Pharmaceuticals and health policy, Blum, R., et al. (eds.). London, Croom Helm, 1981. Pp. 78–92.

    Google Scholar 

  250. Lionel, W., and Herxheimer, A. Coherent policies on drugs: Formulation and implementation. In: Pharmaceuticals and health policy. Blum, R., et al. (eds.). London, Croom Helm, 1981. P. 240.

    Google Scholar 

  251. WHO. Tech. Rep. Ser. 425:5, 1969.

    Google Scholar 

  252. Bulpitt, C.J. Screening for adverse drug reactions. Br. J. Hosp. Med. 18:329–334, 1977.

    PubMed  CAS  Google Scholar 

  253. Böttiger, L.E., and Westerholm, B. Drug-induced blood dyscrasias in Sweden. Br. Med. J. 3:339–343, 1973.

    Article  PubMed  Google Scholar 

  254. Multicentre international study: Reduction in mortality after myocardial infarction with long-term beta-adrenoceptor blockade. Supplementary Report. Br. Med. J. 2:419–421, 1977.

    Article  Google Scholar 

  255. Skegg, D.C.G., and Doll, R. The case for recording events in clinical trials. Br. Med. J. 2:1523–1524, 1977.

    Article  PubMed  CAS  Google Scholar 

  256. Lewis, J.A. Post marketing surveillance: How many patients? Tips (April):93–94, 1981.

    Google Scholar 

  257. Vere, D.W. Controlled trials to detect efficacy and toxicity: Training to meet tomorrow’s needs. In: Principles and practice of clinical trials. Harris, E.L., and Fitzgerald, J.D. (eds.). Edinburgh and London, E. and S. Livingston, 1970. Pp. 242–249.

    Google Scholar 

  258. Mann, R.D., et al. The significance of variations in the serum transaminases in the assessment of two new drugs. In: ‘Experimental studies and clinical experience—the assessment of risk. Proc. Eur. Soc. for the Study of Drug Toxicity, vol. VI. Amsterdam, Excerpta Medica Foundation, 1965.

    Google Scholar 

  259. The coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 231:360–381, 1975.

    Article  Google Scholar 

  260. Knatterud, G.L., et al. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. IV. A preliminary report on phenformin results. JAMA 217:777–784, 1971.

    Article  PubMed  CAS  Google Scholar 

  261. Oliver, M.F. Serum chloesterol—the knave of hearts and the joker. Lancet 2:1090–1095, 1981.

    Article  PubMed  CAS  Google Scholar 

  262. The Anturane Reinfarction Trial Research Group: Sulfinpyrazone in the prevention of sudden death after myocardial infarction. N. Engl. J. Med. 302:250–256, 1980.

    Article  Google Scholar 

  263. Armitage, P. Trials of antiplatelet drugs: some methodological considerations. Rev. Epidemiol Sante Publique 27:87–90, 1979.

    PubMed  CAS  Google Scholar 

  264. Braunwald, E. Treatment of the patient after myocardial infarction. The last decade and the next. N. Engl. J. Med. 302:290–292, 1980.

    Article  PubMed  CAS  Google Scholar 

  265. Kolata, G.B. FDA says no to Anturane. Science 208:1130–1132, 1980.

    Article  PubMed  CAS  Google Scholar 

  266. Mitchell, J.R.A. Secondary prevention of myocardial infarction. The present state of the ART. Br. Med. J. 2:1128–1130, 1980.

    Article  Google Scholar 

  267. European Cooperative Study Group for Streptokinase Treatment in Acute Myocardial Infarction. Streptokinase in acute myocardial infarction. N. Engl. J. Med. 301:797–802, 1979.

    Article  Google Scholar 

  268. Leading Article. Fibrinolytic therapy in myocardial infarction. Br. Med. J. 2:1017–1018, 1979.

    Article  Google Scholar 

  269. Elwood, P.C. Aspirin, dipyridamole and secondary prevention. In: The clinical impact of betaadrenoceptor blockade, Burley, D.M., and Birdwood, G.F.B. (eds.). Horsham, England, Ciba Laboratories, 1980. Pp. 25–26.

    Google Scholar 

  270. Elwood, P.C., et al. A randomised controlled trial of acetyl salicylic acid in the secondary prevention of mortality from myocardial infarction. Br. Med. J. 1:436–440, 1974.

    Article  PubMed  CAS  Google Scholar 

  271. Coronary Drug Project Research Group: Aspirin in coronary disease. J. Chron. Dis. 29:625–642, 1976.

    Article  Google Scholar 

  272. Uberla, K. In: Acetylsalicylic acid in cerebral ischaemia and coronary heart disease. IV. Colfarit Symposium Berlin 1977. Stuttgart and New York, Schattauer Verlag, 1978. P. 157.

    Google Scholar 

  273. Elwood, P.C., and Sweetnam, P.M. Aspirin and secondary mortality after myocardial infarction. Lancet 2:1313–1315, 1979.

    Article  PubMed  CAS  Google Scholar 

  274. Persantine and aspirin in coronary heart disease. The Persantine-Aspirin Reinfarction Study Research Group. Circulation 62:449–461, 1980.

    Article  Google Scholar 

  275. Aspirin Myocardial Infarction Study Group: A randomized, controlled trial of aspirin in persons recovered from myocardial infarction. JAMA 243:661–669, 1980.

    Article  Google Scholar 

  276. Sixty Plus Reinfarction Study Research Group: A double-blind trial to assess long-term oral anticoagulant therapy in elderly patients after myocardial infarction. Lancet 2:989–993, 1980.

    Google Scholar 

  277. Vedin, J. A. Analysis presented at the VIIIth European Congress of Cardiology. Paris, 1980.

    Google Scholar 

  278. Reynolds, J.L., and Whitlock, R.M. Effects of beta-adrenergic receptor blocker in myocardial infarction for one year from onset. Br. Heart J. 34:252–259, 1972.

    Article  PubMed  CAS  Google Scholar 

  279. Ahlmark, G., and Saetre, H. Long-term treatment with β-blocker after myocardial infarction. Eur. J. Clin. Pharmacol. 10:77–83, 1976.

    Article  PubMed  CAS  Google Scholar 

  280. Wilhelmsson, C., et al. Reduction of sudden deaths after myocardial infarction by treatment with alprenolol. Preliminary results. Lancet 2:1157–1160, 1974.

    Article  PubMed  CAS  Google Scholar 

  281. Andersen, M.P., et al. Effect of alprenolol on mortality among patients with definite or suspected acute myocardial infarction. Preliminary results. Lancet 1:865–868, 1979.

    Article  Google Scholar 

  282. Hampton, J.R. Evidence on use of beta-blockers. In: Current themes in cardiology, Birdwood, G.F.B., and Russel, J.G. (eds.). Horsham, England, Geigy Pharmaceuticals, 1981. Pp. 86–89.

    Google Scholar 

  283. Beta blocker heart attack study group. The beta blocker heart attack trial. JAMA 246:2073–2074, 1981.

    Article  Google Scholar 

  284. Schor, S. The university group diabetes program. A statistician looks at the mortality results. JAMA 217:1671–1675, 1971.

    Article  PubMed  CAS  Google Scholar 

  285. Feinstein, A.R. An analytic appraisal of the university group diabetes program (UGDP) study. Clin. Pharmacol. Ther. 12:167–191, 1971.

    PubMed  CAS  Google Scholar 

  286. Data has holes, statistical men report to USV. Drug Trade News, 23 August 1971.

    Google Scholar 

  287. Cornfield, J. The University Group Diabetes Program. A further statistical analysis of the mortality findings. JAMA 217:1676–1687, 1971.

    Article  PubMed  CAS  Google Scholar 

  288. Committee for the assessment of biometric aspects of controlled trials of hypoglycemic agents. JAMA 231:585–608, 1975.

    Google Scholar 

  289. Douglas-Jones, A.P., and Cruickshank, J.M. Once daily dosing with atenolol in patients with mild or moderate hypertension. Br. Med. J. 1:990–991, 1976.

    Article  PubMed  CAS  Google Scholar 

  290. Bulpitt, C.J., and Rose, G.A. Design and conduct of clinical trials. In: The hypertensive patient. Marshall, A.J., and Barritt, D.W. (eds.). Tunbridge Wells, Pitman Medical, 1980. Pp. 494–505.

    Google Scholar 

  291. Harris, W.H. et al. Aspirin prophylaxis of venous thromboembolus after total hip replacement. N. Engl. J. Med. 297:1246–1249, 1977.

    Article  PubMed  CAS  Google Scholar 

  292. Cranberg, L. Do retrospective controls make clinical trials ‘inherently fallacious’? Br. Med. J. 2:1265–1266, 1979.

    Article  PubMed  CAS  Google Scholar 

  293. Leading article. Randomised controlled trials? Br. Med. J. 4:1244–1245, 1979.

    Google Scholar 

  294. Woolf, B. On estimating the relationship between blood group disease. Ann. Hum. Genet. 19:251–253, 1955.

    Article  PubMed  CAS  Google Scholar 

  295. Mantel, N., and Haenszel, W. Statistical aspects of the analysis of data from retrospective studies of disease. J. Natl. Cancer Inst. 22:719–748, 1959.

    PubMed  CAS  Google Scholar 

  296. Mittra, B. Potassium, glucose and insulin in treatment of myocardial infarction. Lancet 2:607–609, 1965.

    Article  PubMed  CAS  Google Scholar 

  297. Hargreaves, M.A., and Maxwell, C. The speed of action of desipramine: a controlled trial. Intl. J. Neuropsychiat. 3:140–141, 1961.

    Google Scholar 

  298. Maxwell, C. Clinical trials, reviews, and the journal of negative results. Br. J. Clin. Pharmacol. 1:15–18, 1981.

    Article  Google Scholar 

  299. Rogers, S.C., and Clay, P.M. A statistical review of controlled trials of imipramine and placebo in the treatment of depressive illness. Br. J. Psychiat. 127:599–603, 1975.

    Article  CAS  Google Scholar 

  300. Fincke, M. Arzneimittelprüfung: Strafbare Versuchsmethoden. Heidelberg/Karlsruhe, 1977.

    Google Scholar 

  301. Leading Article. Controlled trials: Planned deception? Lancet 1:534–535, 1979.

    Google Scholar 

  302. Goldzieher, J.W. et al. A double-blind cross-over investigation of the side effects attributed to oral contraceptives. Fertil. Steril. 22:609–623, 1971.

    PubMed  CAS  Google Scholar 

  303. Pryce, I.G. Clinical research upon mentally ill subjects who cannot give informed consent. Br. J. Psychiat. 133:366–369, 1978.

    Article  CAS  Google Scholar 

  304. Black, D. The paradox of medical care. J. Roy. Coll. Phycns. Lond. 13:57–65, 1979.

    CAS  Google Scholar 

  305. Cochrane, A.L. Attitudes to controlled trials. Paper presented at the 9th International Scientific Meeting of the IEA. Edinburgh, August 1981.

    Google Scholar 

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Authors and Affiliations

  1. Department of Medical Statistics and Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1, UK

    Christopher J. Bulpitt (Senior Lecturer in Epidemiology, Honorary Senior Lecturer in Clinical Pharmacology, Honorary Consultant Physician)

  2. Royal Postgraduate Medical School, London, UK

    Christopher J. Bulpitt (Senior Lecturer in Epidemiology, Honorary Senior Lecturer in Clinical Pharmacology, Honorary Consultant Physician)

  3. Hammersmith Hospital, London, UK

    Christopher J. Bulpitt (Senior Lecturer in Epidemiology, Honorary Senior Lecturer in Clinical Pharmacology, Honorary Consultant Physician)

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  1. Christopher J. Bulpitt
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© 1983 Springer Science+Business Media Dordrecht

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Bulpitt, C.J. (1983). References. In: Randomised Controlled Clinical Trials. Developments in Biostatistics and Epidemiology, vol 1. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-6358-4_21

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  • DOI: https://doi.org/10.1007/978-1-4757-6358-4_21

  • Publisher Name: Springer, Boston, MA

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