Surgical procedures and devices should be evaluated in the same way as medical therapy surgical procedures and devices should be evaluated in the same way as medical therapy

Controlled Clinical Trials

Volumn 18, Issue 6, 1997, Pages 478-487

  Buchwald, Henry ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Device RCTs; FDA; RCT phases; Surgical randomized clinical trials (RCTs)

Indexed keywords

CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; DEVICE; HEALTH CARE COST; HUMAN; RANDOMIZED CONTROLLED TRIAL; SURGICAL TECHNIQUE;

ATTITUDE OF HEALTH PERSONNEL; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EVALUATION STUDIES; HUMANS; RANDOMIZED CONTROLLED TRIALS; SURGERY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030665729     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(96)00114-6     Document Type: Conference Paper

References (26)

1. Chalmers TC. The clinical trial. Milbank Fund Mem Quart 1981;59:324-339.
2. Goligher J. The skeptical chirurgeon. Ann R Coll Surg Engl 1984;66:207-210.
3. Cobb LA. Evaluation of internal mammary artery ligation by double-blind technic. N Engl J Med 1959;260:1115-1118.
4. Chalmers TC, Block JB, Lee S. Controlled studies in clinical cancer research. Clin Cancer Res 1972;287:75-78.
5. Bonchek L. Are randomized trials appropriate for evaluating new operations? N Engl J Med 1979;301:44-45.
6. Swazey JP, Fox RC. The clinical moratorium: a case study of mitral value surgery. In: PA Freund, ed. Experimentation with Human Subjects. New York: Braziller; 1970, pp 315-357.
7. Linton RR, Hardy IB Jr., Volwiler W. Portacaval shunts in the treatment of portal hypertension. Surg Gynecol Obstet 1948;87:129.
8. Smithells R. Iatrogenic hazards and their effects. Postgrad Med J 1975;51(Suppl 2):39-52.
9. Tyson JE. Use of unproven therapies in clinical practice and research: how can we better serve our patients and their families? Seminars in Perinatology 1995;19:98-111.
10. Moynihan SB. Addresses on Surgical Subjects. Philadelphia: WB Saunders Co.; 1928.
11. Buchwald H. NHLBI clinical trials and conflicts of interest. Controlled Clin Trials 1990;11:217-222.
12. Shaw LW, Chalmers TC. Ethics in cooperative clinical trials. Ann NY Acad Sci 1970;169:487-495.
13. Freedman B. Equipose and the ethics of clinical research. N Engl J Med 1987;317:141-145.
14. Pocock SJ. Types of clinical trials. In: Pocock AJ, ed. Clinical Trials. London: John Wiley & Sons, Ltd.; 1983.
15. Levine RJ. Ethics and Regulation of Clinical Research, 2nd edition. Baltimore/Munich: Urban & Schwarzenberg, Inc.; 1986.
16. Moore RB, Franz ID Jr, Buchwald H. Changes in cholesterol pool size, turnover rate, and the fecal bile acid and sterol excretion after partial ileal bypass in hypercholesterolemic patients. Surgery 1969;65:98-108.
17. Sapirstein W, Alpert S, Callahan TJ. The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices. Circulation 1994;89:1900-1902.
18. Meier P. Terminating a trial: The ethical problem. Clin Pharmacol Ther 1979;25:633-640.
19. Buchwald H, Varco RL, Matts JP, et al. Effect of partial ileal bypass surgery on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia. Report of the Program on the Surgical Control of the Hyperlipidemias (POSCH). N Engl J Med 1990;323:946-955.
20. Yusuf S. Zucker D, Peduzzi P, et al. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 1994;344:563-570.
21. Fisher B, Bauer M, Margolese R, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985;312:665-673.
22. Fisher RA. The Design of Experiments. London: Oliver and Boyd; 1935.
23. Wonnacott TH. Bayesian and classical hypothesis testing. J Appl Stat 1986;2:149-157.
24. Sacks HS, Berrier J, Reitman D, Ancona-Berk VA, Chalmers TC. Meta-analysis of randomized controlled trials. N Engl J Med 1987;316:450-455.
25. DerSimonian R, Laird N. Meta-analysis in clinical medicine. Controlled Clin Trials 1986;7:177-188.
26. Lau J, Schmid CH, Chalmers TC. Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. J Clin Epidemiol 1995;48:45-57.