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Related Experiment Video

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How to Study Placebo Responses in Motion Sickness with a Rotation Chair Paradigm in Healthy Participants

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Published on: December 14, 2014

What questions can a placebo answer?

Spencer Phillips Hey¹, Charles Weijer²

¹Division of Pharmacoepidemilogy and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Center for Bioethics, Harvard Medical School, Boston, MA, USA. shey@bwh.harvard.edu.

Monash Bioethics Review

|May 19, 2016

Summary

This summary is machine-generated.

Clinical equipoise, a principle guiding clinical trials, permits placebo use even with existing treatments. A nuanced understanding, distinguishing de facto and de jure equipoise, clarifies when placebo controls are ethically necessary.

Keywords:

Clinical equipoise Placebo controls Randomized controlled trials Research ethics

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Area of Science:

Medical Ethics
Clinical Trial Design
Evidence-Based Medicine

Background:

Clinical equipoise restricts placebo use in trials when effective treatments exist.
Critics cite ethical placebo-controlled trials as counter-examples to equipoise restrictions.
Existing interpretations of clinical equipoise may be overly restrictive regarding placebo controls.

Purpose of the Study:

To re-evaluate the restrictive nature of clinical equipoise on placebo-controlled trials.
To demonstrate that clinical equipoise can accommodate ethical placebo use.
To provide a framework for understanding when placebo controls are necessary.

Main Methods:

Analysis of critical arguments against clinical equipoise.
Conceptual distinction between de facto and de jure interpretations of equipoise.
Philosophical examination of ethical considerations in clinical research.

Main Results:

Clinical equipoise is not as restrictive of placebo use as commonly assumed.
Counter-examples to equipoise do not invalidate the principle.
A subtler appreciation of equipoise clarifies its application.

Conclusions:

Placebo-controlled trials can be ethically justified under specific interpretations of clinical equipoise.
Distinguishing de facto and de jure equipoise is crucial for ethical trial design.
A refined understanding of equipoise supports its continued relevance in clinical research.