Facilitating Antibacterial Drug Development in a Time of Great Need

Clinical Infectious Diseases

Volumn 63, Issue , 2016, Pages S27-S28

  Cox, Edward ^a   Cavaleri, Marco ^b   Eichler, Hans Georg ^b   Woodcock, Janet ^a   Borio, Luciana ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Antibacterial drug; development; public health

Indexed keywords

ANTIINFECTIVE AGENT;

ACUTE DISEASE; ANTIBIOTIC RESISTANCE; ARTICLE; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; DRUG QUALITY; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; PUBLIC-PRIVATE PARTNERSHIP; DRUG DEVELOPMENT;

ANTI-BACTERIAL AGENTS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; HUMANS; PUBLIC-PRIVATE SECTOR PARTNERSHIPS;

EID: 85010915120     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciw257     Document Type: Article

References (6)

1. Boucher HW, Talbot GH, Benjamin DK Jr, et al. Infectious Diseases Society of America. 10 x '20 Progress-development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin Infect Dis 2013; 56:1685-94.
2. Sertkaya A, Eyraud J, Birkenbach A, et al. Analytical framework for examining the value of antibacterial products . Report to the United States Department of Health and Human Services, April 2014. Available at: http://aspe.hhs.gov/sp/reports/2014/antibacterials/rpt-antibacterials.cfm. Accessed 15 February 2016.
3. Knirsch C, Alemayehu D, Botgros R, et al. Improving conduct and feasibility of clinical trials to treat hospital-acquired bacterial pneumonia and ventilatorassociated bacterial pneumonia: recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Working Group. Clin Infect Dis 2016; 63(suppl 2):S29-36.
4. Donnelly H, Alemayehu D, Botgros R, et al. Streamlining safety data collection in hospital-acquired and ventilator-associatedbacterial pneumonia trials. Clin Infect Dis 2016; 63(suppl 2):S39-45.
5. McDonnell A, Rex JH, Goossens H, Bonten M, Fowler VG, Dane A. Efficient delivery of investigational antibacterial agents via a sustainable clinical trials network. Clin Infect Dis 2016; 63(suppl 2):S57-9.
6. Clinical Trial Network for Antibacterial Drugs. Solicitation number: BARDA-RFIClinical Trial Network for Antibacterial Drugs. US Department of Health and Human Services. Available at: https://www.fbo.gov/index?s=opportunity&mode=form&id=c49bbf90a77767a69c9cdf148879f711&tab=core&-cview=0. Accessed 24 February 2016.