David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medicine and Philosophy 11 (4):367-383 (1986)
Conversion of slowly accruing conventionally randomized studies to a prerandomized design has apparently been successful in increasing accrual enough so that some of these studies can be completed. Ellenberg (1984) has pointed out some of the ethical dangers of prerandomization. This paper argues that prerandomization must be either unsuccessful or unethical: either conversion to prerandomization will result in no significant increase in the rate of completion of the study or a significant increase in accrual rate will be achieved either at the price of an inadequate attempt to obtain informed consent, at the price of the deceit of patients, or at the price of violations of patient autonomy. The argument of the paper can be sketched as follows: For any given randomized study, either patients prefer one treatment arm to the other or they do not. On the one hand, if they do, then conventional randomization fails. But prerandomization, if done ethically, will fail also. Hence, if prerandomization succeeds in this sort of case, then the trial has been conducted unethically. On the other hand, if patients do not prefer One arm to the other, then prerandomization will succeed. So will conventional randomization. Hence, prerandomization is either unnecessary or unethical. Ellenberg's concerns count as good moral reasons for not prerandomizing if prerandomization is unnecessary. It follows that prerandomization is always wrong
|Keywords||No keywords specified (fix it)|
|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
Don Marquis (1989). An Ethical Problem Concerning Recent Therapeutic Research on Breast Cancer. Hypatia 4 (2):140 - 155.
Similar books and articles
David Wendler (2009). Must Research Participants Understand Randomization? American Journal of Bioethics 9 (2):3 – 8.
Fred Gifford (1986). The Conflict Between Randomized Clinical Trials and the Therapeutic Obligation. Journal of Medicine and Philosophy 11 (4):347-366.
Loretta Kopelman (1986). Consent and Randomized Clinical Trials: Are There Moral or Design Problems? Journal of Medicine and Philosophy 11 (4):317-345.
Stephen Wear (1995). A Desperate Solution: Individual Autonomy and the Double-Blind Controlled Experiment. Journal of Medicine and Philosophy 20 (1):57-64.
Piotr Zaborowski & Adam Górski (2004). Informed Consent and the Use of Placebo in Poland: Ethical and Legal Aspects. Science and Engineering Ethics 10 (1):167-178.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Jane L. Hutton & Richard E. Ashcroft (2000). Some Popular Versions of Uninformed Consent. Health Care Analysis 8 (1):41-53.
James E. Sabin Kathleen Mazor Vanessa Meterko Sarah L. Goff Richard Platt (2008). Comparing Drug Effectiveness at Health Plans: The Ethics of Cluster Randomized Trials. Hastings Center Report 38 (5):pp. 39-48.
N. Waller Bruce (1995). Individual Autonomy and the Double-Blind Controlled Experiment: The Case of Desperate Volunteers. Journal of Medicine and Philosophy 20 (1).
Added to index2010-08-16
Total downloads25 ( #120,994 of 1,726,249 )
Recent downloads (6 months)1 ( #369,877 of 1,726,249 )
How can I increase my downloads?