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Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial
Thoughts on Compassion
Arch Ophthalmol. 2006;124:1029-1031.
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Compassion: the feeling or emotion, when a person is moved by the suffering or distress of another, and by the desire to relieve it; pity that inclines one to spare or to succour.1
Compassion is an essential component of the moral compass that informs our behavior as physicians. It is at the basis of the principle that the needs of the patient are paramount. However, there are instances in which ethical, legal, or logistical considerations may constrain physicians from acting with what they interpret as compassion. This article explores one such dilemma that sooner or later is apt to confront the clinician.
Most available drugs have been approved by phase 3 trials for some specific indication or indications. Because the risks and benefits have been identified through appropriate testing in human subjects, there is no hesitancy to use them for the appropriate indications. However, there are instances in which we . . . [Full Text of this Article]
AUTHOR INFORMATION
Joan W. Miller, MD
Author Affiliations: Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston.
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