Principles of early stopping of randomized trials for efficacy: A critique of equipoise and an alternative nonexploitation ethical framework

Kennedy Institute of Ethics Journal 15 (2):161-178 (2005)


: Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely

Download options


    Upload a copy of this work     Papers currently archived: 72,856

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library


Added to PP

37 (#311,777)

6 months
1 (#386,016)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Franklin Miller
Columbia University

References found in this work

No references found.

Add more references

Similar books and articles

Statistical Decisions and the Interim Analyses of Clinical Trials.Roger Stanev - 2011 - Theoretical Medicine and Bioethics 32 (1):61-74.
Pulling the Plug on Clinical Equipoise: A Critique of Miller and Weijer.Fred Gifford - 2007 - Kennedy Institute of Ethics Journal 17 (3):203-226.
What Makes Placebo-Controlled Trials Unethical?Franklin G. Miller & Howard Brody - 2002 - American Journal of Bioethics 2 (2):3 – 9.
Uncertainty and the Ethics of Clinical Trials.Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167.
Clinical Equipoise and the Incoherence of Research Ethics.Franklin G. Miller & Howard Brody - 2007 - Journal of Medicine and Philosophy 32 (2):151 – 165.