Increasing the Efficiency of Clinical Trials of Antimicrobials: The Scientific Basis of Substantial Evidence of Effectiveness of Drugs
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Powers discusses the evidence requirements, using examples from clinical trials in diseases such as acute otitis media, acute bacterial sinusitis, and acute exacerbations of chronic bronchitis. Examination of the principles of substantial evidence also points to opportunities to improve the efficiency of confirmatory clinical trials of antimicrobials to obtain more clinically relevant and useful information without increasing the uncertainty regarding the safety and efficacy of these drugs.