Teira, David (2011) Frequentist versus Bayesian Clinical Trials. pp. 255-297.

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Abstract

I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs were accepted for regulatory purposes. I contend that their main virtue, from a regulatory viewpoint, is their impartiality, which is grounded in randomisation and fixed rules for the interpretation of the experiment. Thus the question will be whether Bayesian trials can match or exceed the achievements of frequentist RCTs in all these respects. In the second part of the paper, I will first present a quick glimpse of the introduction of Bayesianism in the field of medical experiments, followed by a summary presentation of the basic tenets of a Bayesian trial. The point here is to show that there is no such thing as “a” Bayesian trial. Bayesianism can ground many different approaches to medical experiments and we should assess their respective virtues separately. Thus I present two actual trials, planned with different goals in mind, and assess their respective epistemic, ethical and regulatory merits. In a tentative conclusion, I contend that, given the constraints imposed by our current regulatory framework, impartiality should preside over the design of clinical trials, even at the expense of many of their inferential and ethical virtues.

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Item Type:	Published Article or Volume
Creators:	Creators Email ORCID Teira, David
Keywords:	clinical trials bayesianism frequentism ethics methodology
Subjects:	Specific Sciences > Medicine > Clinical Trials General Issues > Evidence General Issues > Experimentation Specific Sciences > Medicine
Depositing User:	Prof. David Teira
Date Deposited:	28 Sep 2020 12:26
Last Modified:	28 Sep 2020 12:26
Item ID:	18152
Official URL:	http://doi.org/10.1016/b978-0-444-51787-6.50010-6
DOI or Unique Handle:	10.1016/b978-0-444-51787-6.50010-6
Subjects:	Specific Sciences > Medicine > Clinical Trials General Issues > Evidence General Issues > Experimentation Specific Sciences > Medicine
Date:	2011
Page Range:	pp. 255-297
URI:	https://philsci-archive.pitt.edu/id/eprint/18152

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