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3
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Although this is the typical form of expression of the null hypothesis, it would be more accurate to say ‘therapy A = therapy B in the accomplishment of objective O in population P,” where objective O is the endpoint under examination (e.g., lowering of blood pressure) and population P is a subset of those patients with disease D (e.g., essential hypertension) who have the necessary attributes (inclusion criteria and lack of exclusion criteria) to be eligible for participation in the RCT.
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The Doctor's Unproven Beliefs and the Subject's Informed Choice
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H.Y. Vander‐pool and G.B. Weiss, ‘False Data and Last Hopes: Enrolling Ineligible Patients in Clinical Trials,”Hastings Center Report, 17, 2, (April 1987): 16–19
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(1988)
IRB: Ethics and Human Research
, vol.10
, Issue.2
, pp. 3-5
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Marquis, D.1
Stephens, R.2
Siris, E.S.3
Kemeny, M.M.4
Levine, R.J.5
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14
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84985177896
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‘The Request of the National Institutes of Health for a Limited Exemption from the Freedom of Information Act,” Report Submitted to the Secretary, DHHS
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(1980)
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A full discussion of prerandomization designs is beside the point of this article; such a discussion may be found in R.J. Levine, supra note 2, at 194–97.
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84985177868
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Actually, most consent forms for placebo‐controlled RCTs which I have sea do not use the expression, ‘it is not known.” Many of them provide information based upon which prospective subjects could make either of two seemingly inconsistent inferences: 1 The consent form usually refers to preliminary evidence that the active drug is effective and labels the placebo as ‘an inert substance.” In presenting the risks of placebo, it may also refer to the perils of withholding active therapy. From such information the prospective subject could reasonably infer that the investigator already believes that the active drug is more likely than not to prove superior to placebo. 2 Institutional Review Boards (IRBs) generally constrain investigators from making clear statements that the investigational drug is likely to be effective, reasoning that if this were already known, it would invalidate the null hypothesis used to justify the RCT. Following this reasoning, grounded in the concept of theoretical equipoise, it is considered unethical to tell subjects that a new drug is likely to be effective until the RCT demonstrates that it is. IRBs generally require that subjects be informed that ‘the purpose of this study is to determine whether the drug is effective.” Since in order to do this it will be compared with placebo, the subject could infer that ‘it is not known whether the new drug is her or worse than placebo.”.
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Id.
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For further discussion of such justification, see, supra note 2, at 2024.
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Levine, R.J.1
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34
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84985177701
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For further elaboration of this point including the specifics of what ought to be disclosed and explained, see, supra note 2, at 200–01.
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Levine, R.J.1
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35
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0020806898
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Report on Do Not Resuscitate Decisions
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(1985)
Connecticut Medicine
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, pp. 477-483
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I have discussed the leading criticisms of RCTs in RJ. Levine, supra note 2, at 207–210.
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84936527430
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Statistical Analysis and the Illusion of Objectivity
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A full discussion of why some statisticians prefer Bayesian methods is beyond the scope of this discussion. For a very had exposition of the problem in which the relevant concepts are made accessible to the relatively unsophisticated reader, see
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(1988)
American Scientist
, vol.76
, pp. 159-165
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Berger, J.O.1
Berry, D.A.2
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