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Controversies |

Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial:  Thoughts on Compassion

Joan W. Miller, MD
Arch Ophthalmol. 2006;124(7):1029-1031. doi:10.1001/archopht.124.7.1029.
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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 find ourselves tempted to use an “approved” drug for another indication for which the risks and benefits have not been established by phase 3 trials. In addition, we may contemplate the use of drugs that are in the process of being evaluated or for which such evaluations are contemplated. We occasionally must decide whether we should enroll a patient in a clinical trial in which he or she may receive a placebo or a drug that is by definition yet to be approved. In making all of these decisions, it is important to recognize that the likely alternative—not to treat the patient with the drug in question—carries with it risks that may be more difficult to anticipate than those established in the phase 3 trial of the drug. Either course of action may also leave the physician vulnerable to allegations of medical negligence.

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