메뉴 건너뛰기




Volumn 16, Issue 3-4, 1988, Pages 174-182

Uncertainty in Clinical Research

Author keywords

[No Author keywords available]

Indexed keywords

ALTERNATIVES; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; DOCTOR PATIENT RELATION; DRUG THERAPY; HUMAN; HUMAN EXPERIMENT; INTERPERSONAL COMMUNICATION; MEDICAL ETHICS; METHODOLOGY; PATIENT SELECTION; RANDOMIZATION; RISKS AND BENEFITS; SELECTION OF SUBJECTS;

EID: 84985225025     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1988.tb01943.x     Document Type: Article
Times cited : (28)

References (42)
  • 3
    • 84985180410 scopus 로고    scopus 로고
    • 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.
  • 14
    • 84985177896 scopus 로고
    • ‘The Request of the National Institutes of Health for a Limited Exemption from the Freedom of Information Act,” Report Submitted to the Secretary, DHHS
    • (1980)
  • 21
    • 84985197583 scopus 로고    scopus 로고
    • 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.
  • 23
    • 84985177868 scopus 로고    scopus 로고
    • 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.”.
  • 25
    • 84985216901 scopus 로고    scopus 로고
    • Id.
  • 26
    • 84985283824 scopus 로고    scopus 로고
    • For further discussion of such justification, see, supra note 2, at 2024.
    • Levine, R.J.1
  • 34
    • 84985177701 scopus 로고    scopus 로고
    • For further elaboration of this point including the specifics of what ought to be disclosed and explained, see, supra note 2, at 200–01.
    • Levine, R.J.1
  • 35
  • 38
    • 84985195262 scopus 로고    scopus 로고
    • I have discussed the leading criticisms of RCTs in RJ. Levine, supra note 2, at 207–210.
  • 42
    • 84936527430 scopus 로고
    • Statistical Analysis and the Illusion of Objectivity
    • 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
    • (1988) American Scientist , vol.76 , pp. 159-165
    • Berger, J.O.1    Berry, D.A.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.