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

George H. Talbot, John H. Powers, Steven C. Hoffmann, Joseph Toerner, George H. Talbot, Jeff Alder, Mari Ariyasu, Steve Barriere, Helen Boucher, Colin Broom, Michael Brunda, Sue Cammarata, Tricia Cimms, Becky Coleman, Lynn Connolly, Edward M. Cox, Aaron Dane, Anita Das, Dennis DIxon, Mike DudleyBarry Eisenstein, Roger Echols, Tarek El-Akkad, Thomas File, Thomas R. Fleming, Dean Follmann, H. David Friedland, Ian Friedland, Nicholas A. Kartsonis, Achim Kaufhold, Amy Kindrick, Marc Lesnick, Lily Llorens, Jeff Loutit, John Powers, Philippe Prokocimer, John H. Rex, Dan Rubin, Ashley Slagle, Anthony Suffredini, Antoni Torres, Larry Tsai, Michele Wible, Richard Wunderink

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

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 languageEnglish (US)
Pages (from-to)603-607
Number of pages5
JournalClinical Infectious Diseases
Volume62
Issue number5
DOIs
StatePublished - 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

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