Bayesian versus frequentist clinical trials
In Gifford Fred (ed.), Philosophy of Medicine [Handbook of Philosophy of Science, vol. 16],. Elsevier (2011)
| 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. | |||||||||
| Keywords | Philosophy of medicine Philosophy of probability Clinical trials | |||||||||
| Categories | ||||||||||
| Options |
|
|||||||||
Download options| PhilPapers Archive |
Upload a copy of this paper Check publisher's policy on self-archival Papers currently archived: 5,631 |
| External links |
  Try with proxy. |
| Through your library | Configure |
Similar books and articlesDavid Teira (2011). Frequentist Versus Bayesian Clinical Trials. In Fred Gifford (ed.), Philosophy of Medicine. Elsevier.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Roger Stanev (2011). Statistical Decisions and the Interim Analyses of Clinical Trials. Theoretical Medicine and Bioethics 32 (1):61-74.
Joseph B. Kadane (1986). Progress Toward a More Ethical Method for Clinical Trials. Journal of Medicine and Philosophy 11 (4):385-404.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Marcin Waligora (forthcoming). A European Consistency for Functioning of RECs? We Just Lost Our Chance. Journal of Medical Ethics.
Lisa R. Stines & Norah C. Feeny (2008). Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions. Ethics and Behavior 18 (2 & 3):234 – 246.
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
Margaret B. Liu (2010). A Clinical Trials Manual From the Duke Clinical Research Institute: Lessons From a Horse Named Jim. Wiley-Blackwell.
Gary E. Marchant & Rachel A. Lindor (2012). Prudent Precaution in Clinical Trials of Nanomedicines. Journal of Law, Medicine and Ethics 40 (4):831-840.
Audrey R. Chapman & Courtney C. Scala (2012). Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy. Kennedy Institute of Ethics Journal 22 (3):243-261.
Marta García Alonso & David Teira Serrano (2006). Normas Éticas y Estadísticas En la Justificación de Los Ensayos Clínicos Aleatorizados (Ethical and Statistical Norms in the Justification of Randomised Clinical Trials). Crítica 38 (113):39 - 60.
Franklin G. Miller & Howard Brody (2007). Clinical Equipoise and the Incoherence of Research Ethics. Journal of Medicine and Philosophy 32 (2):151 – 165.
Marek Czarkowski (2006). The Protection of Patients' Rights in Clinical Trials. Science and Engineering Ethics 12 (1):131-138.
Analytics
Monthly downloads |
Added to index2012-04-11Total downloads3 ( #201,695 of 548,973 )Recent downloads (6 months)2 ( #37,438 of 548,973 )How can I increase my downloads? |
My notes
Discussion
