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Uncertain Compassion in Using a Drug Before the Risks and Benefits Are Known
Arch Ophthalmol. 2006;124:1032-1034.
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First, do no harm," is a critical dictum in medical practice. Medical practitioners from ancient times to the present have used individual and shared scientific observations to determine the risks and benefits of individual therapies. However, the yield in this somewhat random process is certainly low. Since the development of the modern pharmaceutical industry as well as the Food and Drug Administration (FDA) as a regulatory agency, we as a medical and scientific community have been held to higher standards to provide proof of safety and efficacy of new treatments through randomized clinical trials.
Phase 3 randomized clinical trials are the final phase of testing prior to FDA approval of a drug or technology for marketing. In general, this level of study compares the results of patients randomly assigned to a new treatment with those of a control group of patients randomly assigned to standard treatment or placebo to assess . . . [Full Text of this Article]
AUTHOR INFORMATION
Raja Narayanan, MD;
Baruch D. Kuppermann, MD, PhD
Author Affiliations: Department of Ophthalmology, University of California Irvine (Drs Narayanan and Kuppermann), and LV Prasad Eye Institute, Banjara Hills, Hyderabad, India (Dr Narayanan).
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