Abstract
One important component in determining the benefits and harms of medical interventions is the use of well-defined and reliable outcome assessments as endpoints in clinical trials. Improving endpoints can better define patient benefits, allowing more accurate assessment of drug efficacy and more informed benefit-vs-risk decisions; another potential plus is facilitating efficient trial design. Since our first report in 2012, 2 Foundation for the National Institutes of Health Biomarkers Consortium Project Teams have continued to develop outcome assessments for potential uses as endpoints in registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. In addition, the teams have initiated similar work in the indications of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This report provides an update on progress to date in these 4 diseases.
Original language | English (US) |
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Pages (from-to) | 603-607 |
Number of pages | 5 |
Journal | Clinical Infectious Diseases |
Volume | 62 |
Issue number | 5 |
DOIs | |
State | Published - Mar 1 2016 |
Keywords
- Antibacterial drug development
- Early clinical response
- Noninferiority trial design
- PRO
- Patient-reported outcome
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases