David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Science and Engineering Ethics 10 (1):73-79 (2004)
The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ, where Δ is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control — following the latest revision of Declaration of Helsinki — is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients’ rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless.
|Keywords||placebo active-control superiority non-inferiority informed consent uncertainty principle|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Mark D. Sullivan (1993). Placebo Controls and Epistemic Control in Orthodox Medicine. Journal of Medicine and Philosophy 18 (2):213-231.
James A. Anderson (2006). The Ethics and Science of Placebo-Controlled Trials: Assay Sensitivity and the Duhem-Quine Thesis. Journal of Medicine and Philosophy 31 (1):65 – 81.
Jeremy Sugarman (2004). Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials. Science and Engineering Ethics 10 (1):29-35.
Zbigniew Szawarski (2004). The Concept of Placebo. Science and Engineering Ethics 10 (1):57-64.
Thomas R. Weihrauch (2004). Placebo Treatment is Effective Differently in Different Diseases — but is It Also Harmless? A Brief Synopsis. Science and Engineering Ethics 10 (1):151-155.
Ernst A. Singer (2004). The Necessity and the Value of Placebo. Science and Engineering Ethics 10 (1):51-56.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Jacek Spławiński, Jerzy Kuźniar, Krzysztof Filipiak & Waldemar Zieliński (2006). Evaluation of Drug Toxicity in Clinical Trials. Science and Engineering Ethics 12 (1):139-145.
Added to index2009-01-28
Total downloads21 ( #114,946 of 1,696,431 )
Recent downloads (6 months)9 ( #61,625 of 1,696,431 )
How can I increase my downloads?