Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You and Your Team.

Learn More →

Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial

Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial CONTROVERSIES SECTION EDITOR: NEIL M. BRESSLER, MD Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial Thoughts on Compassion Joan W. Miller, MD Compassion: the feeling or emotion, when approved. In making all of these de- at the highest level. Meta-analyses of a person is moved by the suffering or dis- cisions, it is important to recognize randomized controlled trials are also tress of another, and by the desire to re- that the likely alternative—not to ranked at the highest level. The next lieve it; pity that inclines one to spare or treat the patient with the drug in level includes other clinical trials; to succour. question—carries with it risks that nonrandomized, cohort, or case- may be more difficult to anticipate control studies; or multitime se- Compassion is an essential compo- than those established in the phase ries. The third level of evidence is de- nent of the moral compass that in- 3 trial of the drug. Either course of rived from descriptive studies, case forms our behavior as physicians. action may also leave the physician reports, reports of expert commit- It is at the basis of the principle vulnerable to allegations http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Ophthalmology American Medical Association

Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial

JAMA Ophthalmology , Volume 124 (7) – Jul 1, 2006

Loading next page...
 
/lp/american-medical-association/using-a-drug-before-the-risks-and-benefits-are-known-from-a-phase-3-5rr01Sf8Mx
Publisher
American Medical Association
Copyright
Copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6165
eISSN
2168-6173
DOI
10.1001/archopht.124.7.1029
pmid
16832027
Publisher site
See Article on Publisher Site

Abstract

CONTROVERSIES SECTION EDITOR: NEIL M. BRESSLER, MD Using a Drug Before the Risks and Benefits Are Known From a Phase 3 Clinical Trial Thoughts on Compassion Joan W. Miller, MD Compassion: the feeling or emotion, when approved. In making all of these de- at the highest level. Meta-analyses of a person is moved by the suffering or dis- cisions, it is important to recognize randomized controlled trials are also tress of another, and by the desire to re- that the likely alternative—not to ranked at the highest level. The next lieve it; pity that inclines one to spare or treat the patient with the drug in level includes other clinical trials; to succour. question—carries with it risks that nonrandomized, cohort, or case- may be more difficult to anticipate control studies; or multitime se- Compassion is an essential compo- than those established in the phase ries. The third level of evidence is de- nent of the moral compass that in- 3 trial of the drug. Either course of rived from descriptive studies, case forms our behavior as physicians. action may also leave the physician reports, reports of expert commit- It is at the basis of the principle vulnerable to allegations

Journal

JAMA OphthalmologyAmerican Medical Association

Published: Jul 1, 2006

References