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Journal of Clinical Oncology, Vol 23, No 19 (July 1), 2005: pp. 4469 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.01.4134
In Reply:Parnassus, Park Hill, Loughton, Essex, UK I read with interest the commentary of Wieand and Murphy, and I salute them as cancer survivors.1 They and numerous similar survivors provide the testimony to the advances that are constantly being made in the war against cancer. Such progress however is, arguably, the result of the astonishing developments in molecular science that we have witnessed, especially in recent years, rather than the product of the randomized trial. Wieand and Murphy seem to agree that despite random assignment, imbalances can still occur in the strata of a trial that require addressing. If so, the argument of "selection bias" in observational studies becomes irrelevant because with appropriate statistical analyses of prognostic factors, such bias will be revealed or challenged. Wieand and Murphy are under the misapprehension that my discussion of the ethical dimension of the randomized trial consists of "specific concerns rather than a general theme." The reverse is true. My thesis rests on two core arguments2: (1) Should the patient, especially the patient with life-threatening cancer, be addressed as a utility in the pursuit of knowledge and advancement of medicine? Wieand and Murphy, themselves cancer survivors, are comfortable with this view; others are not.2,3 (2) Does the randomized trial provide information that "cannot possibly" be obtained by other means? Wieand and Murphy believe that this is the case; others disagree.2-5 Wieand and Murphy "do not believe that it is the responsibility (indeed the right) of the physician to automatically recommend treatment." Despite this extraordinary statement, most patients recognize the physician as central to their welfare, for which the physician remains morally and legally accountable. Several other ethical and methodological issues have not been addressed in my article because of space constraints. Michael Dosik addresses one of these, namely the withholding of information from study participants of emerging results as the study progresses. He rightly raises concerns "with the currently widely accepted tactic of withholding such information until the study has enough data to be scientifically valid." In essence, Dosik raises the question, does the trialist's loyalty rest with the individual patient or the trial? It is agreed with Dosik that this is a real ethical problem that is currently obfuscated. Instead, it should be acknowledged and openly discussed. Author's Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. REFERENCES
1. Wieand S, Murphy K: A commentary on treatment at random: The ultimate science or the betrayal of Hippocrates? J Clin Oncol 22:5009-5011, 2004
2. Retsas S: Treatment at random: The ultimate science or the betrayal of Hippocrates? J Clin Oncol 22:5005-5008, 2004 3. Hellman S, Hellman DS: Of mice but not men: Problems of the randomized clinical trial. N Engl J Med 324:1585-1589, 1991[Medline]
4. Concato J, Shah N, Horwitz R: Randomized, controlled trials, observational studies and the hierarchy of research designs. N Engl J Med 342:1887-1892, 2000
5. Benson K, Hartz AJ: A comparison of observational studies and randomized controlled trials. N Engl J Med 342:1878-1886, 2000
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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