John H. Powers

TL;DR: Developing and use of patient-reported outcomes in clinical trials to evaluate medical products and major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling are reviewed.

TL;DR: Results show the 37-item Flu-PRO is a content valid measure of influenza symptoms in adults with a confirmed diagnosis of influenza.

TL;DR: In insight into why indirect measures such as biomarkers may fail to provide reliable evidence about the benefit-to-risk profile of interventions, the definitions of clinically meaningful endpoints and surrogate endpoints are discussed, and examples from recent clinical trials are provided.

TL;DR: Clinicians are likely to continue to encounter patients with fluoroquinolone-resistant Campylobacter infection and other enteric infection because of the continued circulation of fluoroquol one-time-use enrofloxacin in poultry flocks and in persons returning from foreign travel who have acquired a fluoroQO2-resistantEnteric infection while abroad.

TL;DR: The World Health Organization has developed and applied criteria to rank antimicrobials according to their relative importance in human medicine, and this ranking allows stakeholders to focus risk management efforts on drugs used in food animals that are the most important to human medicine and, thus, need to be addressed most urgently.