| Title: |
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 |
| Authors: |
Talbot, George H.; Powers, John H.; Hoffmann, Steven C.; for the Biomarkers Consortium of the Foundation for the National Institutes of Health CABP-ABSSSI and HABP-VABP Project Teams; Toerner, Joseph; Alder, Jeff; Ariyasu, Mari; Barriere, Steve; Boucher, Helen; Broom, Colin; Brunda, Michael; Cammarata, Sue; Cimms, Tricia; Coleman, Becky; Connolly, Lynn; Cox, Edward M.; Dane, Aaron; Das, Anita; Dixon, Dennis; Dudley, Mike; Eisenstein, Barry; Echols, Roger; El-Akkad, Tarek; File, Thomas; Fleming, Thomas R.; Follmann, Dean; Friedland, H. David; Friedland, Ian; Kartsonis, Nicholas A.; Kaufhold, Achim; Kindrick, Amy; Lesnick, Marc; Llorens, Lily; Loutit, Jeff; Powers, John; Prokocimer, Philippe; Rex, John H.; Rubin, Dan; Slagle, Ashley; Suffredini, Anthony; Torres, Antoni; Tsai, Larry; Wible, Michele; Wunderink, Richard |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2016 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
VIEWPOINTS |
| Description: |
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. |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://cid.oxfordjournals.org/cgi/content/short/62/5/603; http://dx.doi.org/10.1093/cid/civ927 |
| DOI: |
10.1093/cid/civ927 |
| Availability: |
http://cid.oxfordjournals.org/cgi/content/short/62/5/603; https://doi.org/10.1093/cid/civ927 |
| Rights: |
Copyright (C) 2016, Infectious Diseases Society of America |
| Accession Number: |
edsbas.F9345855 |
| Database: |
BASE |