Unknown

Dataset Information

0

Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health.


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.

SUBMITTER: Talbot GH 

PROVIDER: S-EPMC4741356 | BioStudies | 2016-01-01T00:00:00Z

REPOSITORIES: biostudies

Similar Datasets

1000-01-01 | S-EPMC3529608 | BioStudies
2020-01-01 | S-EPMC7648778 | BioStudies
2012-01-01 | S-EPMC3295120 | BioStudies
2019-01-01 | S-EPMC6669290 | BioStudies
2013-01-01 | S-EPMC4108109 | BioStudies
2017-01-01 | S-EPMC5661904 | BioStudies
2017-01-01 | S-EPMC5595776 | BioStudies
2018-01-01 | S-EPMC6093995 | BioStudies
2020-01-01 | S-EPMC7318031 | BioStudies
2021-01-01 | S-EPMC7844782 | BioStudies