Abstract
Here we review the history of clinical trials. We focus specifically on surgical trials along with the ethics and design of randomized controlled trials.
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References
Majno G. The healing hand: man and wound in the ancient world. Boston: Harvard University Press; 1975.
Nutton V. Ancient medicine. New York: Routledge; 2004.
Flannery M. Avicenna [updated 12 Oct 2018]. https://www.britannica.com/biography/Avicenna. Accessed 5 Dec 2018.
Sirasai N. Avicenna in renaissance Italy: the canon and medical teaching in Italian universities after 1500. Princeton: Princeton University Press; 1987.
Siraisi NG. Medieval and early renaissance medicine. Chicago: University of Chicago Press; 1990.
Packard F. The life and times of Ambroise Paré. 2nd ed. New York: Paul B. Hoeber; 1925.
Paré A. The apologie and treatise of Ambroise Paré. Birmingham, Al: Classics Of Medicine Library; 1984.
Ambroise Paré et l’examen d’un malade. 2011. https://commons.wikimedia.org/wiki/File:James_Bertrand-Ambroise_Paré.jpg.
Solís C. Bartolomé Hidalgo de Agüero’s 16th century, evidence-based challenge to the orthodox management of wounds. 2011. http://www.jameslindlibrary.org/articles/bartolome-hidalgo-de-agueros-16th-century-evidence-based-challenge-to-the-orthodox-management-of-wounds/. Accessed 9 Dec 2018.
Lind J. A treatise of the scurvy in three parts. Containing an inquiry into the nature, causes and cure of that disease, together with a critical and chronological view of what has been published on the subject. London: A. Millar; 1753.
Bilguer M. A dissertation on the inutility of the amputation of the limbs. London: Baldwin, Becket and de Hondt; 1764.
Alanson E. Practical observations on amputation, and the after-treatment. 2nd ed. London: Joseph Johnson; 1782.
Poisson D, Larrey D, editors. Recherches de statistique sur l’affection calculeuse, par M. le docteur Civiale. Comptes rendus hebdomadaires des séances de l’Académie de Sciences [Statistical research on (urinary) stone, by M. Dr Civiale]. Paris: Bachelier; 1835.
Cheseldon W. The anatomy of the human body. 5th ed. London: William Bowyer; 1740. http://www.jameslindlibrary.org/cheselden-w-1740/. Accessed 14 Dec 2018
Tröhler U. “To improve the evidence of medicine”: the 18th century British origins of a critical approach. Edinburgh: Royal College of Physicians of Edinburgh; 2000.
Morabia A. Pierre-Charles-Alexandre Louis and the evaluation of bloodletting. J R Soc Med. 2006;99(3):158–60.
Ackerknecht EH. Medicine at the Paris hospital, 1794–1848. Baltimore: Johns Hopkins Press; 1967.
Tröhler U. Statistics and the British controversy about the effects of Joseph Lister’s system of antisepsis for surgery, 1867–1890. 2014. http://www.jameslindlibrary.org/articles/statistics-and-the-british-controversy-about-the-effects-of-joseph-listers-system-of-antisepsis-for-surgery-1867-1890/. Accessed 9 Dec 2018.
Pernick M. A Calculus of suffering: pain, profession, and anesthesia in 19th century America. New York: Columbia University Press; 1985.
Chalmers I. Why the 1948 MRC trial of streptomycin used treatment allocation based on random numbers. J R Soc Med. 2011;104(9):383–6.
Hamilton AL. Dissertatio Medica Inauguralis De Synocho Castrensi. Edinburgh: J Ballantyne; 1816. Accessed 9 Dec 2018.
Hill B. Clinical lectures on the stricture of the urethra. BMJ. 1879;2:883–6.
Fox LW. Immediate capsulotomy following the removal of cataract. JAMA. 1894;22:837–9.
Langton J. A discussion on the treatment of hernia in children. BMJ. 1899;2:470–2.
Jones DS. Surgery and clinical trials: the history and controversies of surgical evidence. In: Schlich T, editor. The Palgrave handbook of the history of surgery. Montreal: Macmillan Publishers; 2018. p. 479–501.
Barnes BA. Discarded operations: surgical innovation by trial and error. Costs, risks and benefits of surgery. New York: Oxford University Press; 1977. p. 109–23.
Lerner BH. The breast cancer wars: fear, Hope, and the pursuit of a cure in twentieth-century America. New York: Oxford University Press; 2011.
Wilde S. See one, do one, modify one: prostate surgery in the 1930s. Med Hist. 2004;48:351–66.
HIlts P. Protecting America’s health: the FDA, business, and one hundred years of regulation. Chapel Hill: University of North Carolina Press; 2003.
Amberson J, McMahon B, Pinner M. A clinical trial of sanocrysin in pulmonary tuberculosis. Am Rev Tuberc. 1931;24:401–35.
Brock B. The sanocrysin treatment of pulmonary tuberculosis in the white and negro races. Am Rev Tuberc. 1931;24:436–45.
Diaz M. Lessons from using randomization to assess gold treatment for tuberculosis. 2004. http://www.jameslindlibrary.org/articles/lessons-from-using-randomization-to-assess-gold-treatment-for-tuberculosis/. Accessed 10 Dec 2018.
Marshall G, Crofton J, Hurford J, Brent R, Ross I, Gilmour WS, et al. Streptomycin treatment of pulmonary tuberculosis: a medical research council investigation. Br Med J. 1948;2(4582):769–82.
Knapp MR, Beecher HK. Postanesthetic nausea, vomiting, and retching; evaluation of the antiemetic drugs dimenhydrinate (dramamine), chlorpromazine, and pentobarbital sodium. J Am Med Assoc. 1956;160(5):376–85.
Conn HO, Lindenmuth WW. Prophylactic Portacaval anastomosis in cirrhotic patients with esophageal varices—a preliminary report of a controlled study. N Engl J Med. 1962;266:743–9.
Brinkley D, Haybittle JL. Treatment of stage-II carcinoma of the female breast. Lancet. 1966;288:291–5.
Cobb L, Thomas G, Dillard D, Merendino K, Bruce R. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med. 1959;260:1115–8.
Crenner C. Placebos and the progress of surgery. In: Schlich T, Crenner C, editors. Technological change in modern surgery. Rochester: University of Rochester Press; 2017. p. 156–84.
Goligher JC, Pulvertaft CN, Watkinson G. Controlled trial of vagotomy and gastro- enterostomy, vagotomy and antrectomy, and subtotal gastrectomy in elective treatment of duodenal ulcer: interim report. Br Med J. 1964;1(5381):455–60.
Handley WS. Cancer of the breast and its operative treatment. London: Murray; 1906.
Ellis H. A history of surgery. London: Greenwich Medical Media; 2001.
Halsted WS. The results of radical operations for the cure of carcinoma of the breast. Ann Surg. 1907;46:1.
Lane-Claypon J. Reports on public health, medical subjects. London, H.M. Stationary Office; 1924.
William Stewart Halsted, surgical papers. Wellcome Collection. https://wellcomecollection.org/works/bpn6hxgq?query=L0004968.
McWhirter R. Simple mastectomy and radiotherapy in treatment of breast cancer. Brit J Radiol. 1955;28:128–39.
Williams I, Murley R, Curwen M. Carcinoma of the female breast: conservative and radical surgery. Brit Med J. 1953;2:787–96.
Mustakallio S. Treatment of breast cancer by tumor extirpation and roentgen therapy instead of radical operation. J Facult Radiol. 1956;6:23–6.
George Crile J. Simplified treatment of cancer of the breast: early results of a clinical study. Ann Surg. 1961;153:745–61.
Lee BJ. The therapeutic value of irradiation in the treatment of mammary cancer: a survey of five-year results in 355 cases treated at the memorial hospital of New York. Ann Surg. 1928;88(1):25–47.
Grace EJ. Simple mastectomy in cancer of the breast. Am J Surg. 1937;35:512–4.
Holman E. Sir William Osler, William Stewart Halsted, Harvey Cushing: some personal reminiscences. Surgery. 1965;57:589–601.
Kaae S, Johansen H. Simple mastectomy plus postoperative irradiation by the method of McWhirter for mammary carcinoma. Ann Surg. 1969;170(6):895–9.
Fisher B, Jeong J, Anderson S, Bryant J, Fisher E, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002;347(8):567–75.
McPherson K, Fox M. Treatment of breast cancer. In: Bunker J, Barnes B, Mosteller F, editors. Costs, risks and benefits of surgery. Oxford: Oxford University Press; 1977. p. 308–22.
Ellis J, Mulligan I, Rowe J, Sackett DL. Inpatient general medicine is evidence based. A-Team, Nuffield Department of Clinical Medicine. Lancet. 1995;346(8972):407–10.
Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. BJS. 1997;84(9):1220–3.
Kenny SE, Shankar KR, Rintala R, Lamont GL, Lloyd DA. Evidence-based surgery: interventions in a regional paediatric surgical unit. Arch Dis Child. 1997;76(1):50.
Wente MN, Seiler CM, Uhl W, Buchler MW. Perspectives of evidence-based surgery. Dig Surg. 2003;20(4):263–9.
Gelijns AC, Ascheim DD, Parides MK, Kent KC, Moskowitz AJ. Randomized trials in surgery. Surgery. 2009;145(6):581–7.
Horton R. Surgical research or comic opera: questions, but few answers. Lancet. 1996;347(9007):984–5.
Wilde S, Hirst G. Learning from mistakes: early twentieth-century surgical practice. J Hist Med Allied Sci. 2009;64(1):38–77.
McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999;23:1210–4.
Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg. 2002;194(6):792–801.
McCulloch P, Altman D, Campbell WB, Flum D, Glasziou P, Marshall J, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374:1105–12.
Love J. In comment: drugs and operations: some important differences. JAMA. 1975;232:37–8.
Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med. 1999;341(13):992.
Lederer SE. Subjected to science: human experimentation in American before the second world war. Baltimore: The Johns Hopkins University Press; 1995.
Cutter L. Walter reed, yellow fever, and informed consent. Mil Med. 2016;181(1):90–1.
Moreno JD. Undue risk: secret state experiments on humans. New York: W.H. Freeman; 2000.
Krantz J. New drugs and the Kefauver-Harris amendment. J New Drugs. 1966;6(22):77–9.
Jones D, Grady C, Lederer S. “Ethics and clinical research”—the 50th anniversary of Beecher’s bombshell. N Engl J Med. 2016;374:2393–8.
Jones J. The Tuskegee syphilis experiment—a moral astigmatism. In: Harding S, editor. The racial economy of science: toward a democratic future. Bloomington: Indiana University Press; 1993. p. 275–86.
Reverby S. Examining Tuskegee: the infamous syphilis study and its legacy. Chapel Hill: University of North Carolina Press; 2009.
OHRP. The Belmont report [updated 15 Mar 2016]. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Accessed 16 Dec 2018.
Burger ISJ, Goodman SN. Ethical issues in evidence-based surgery. Surg Clin N Am. 2006;86:151–68.
ACo S. Statement on issues to be considered before new surgical technology is applied to the care of patients. Bull Am Coll Surg. 1995;80:46–7.
Rubin E, Lazar D. Clinical trials office: what is new in research administration? Washington, DC: Association for Academic Health Centers; 2009.
EBCTCG. Treatment of early breast cancer. Vol 1. Worldwide evidence, 1985–1990. Oxford: Oxford University Press; 1990. http://www.jameslindlibrary.org/early-breast-cancer-trialists-collaborative-group-1990/.
Kelahan A, Catalano R, Marinucci D. The history, structure, and achievements of the cancer cooperative groups. Managed Care Cancer. 2001:28–33.
Volpe M, Tocci G. Fewer mega-trials and more clinically oriented studies in hypertension research? The case of blocking the renin-angiotensin-aldosterone system. J Am Soc Nephrol. 2006;17(4 (Suppl 2):S36–43.
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Hu, J., Barr, J., Beasley, G.M. (2020). The History of Clinical Trials. In: Pawlik, T., Sosa, J. (eds) Clinical Trials. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-35488-6_1
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