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Review
. 2012 Oct;55(8):1114-21.
doi: 10.1093/cid/cis566. Epub 2012 Jun 28.

Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health

George H Talbot  1 , John H Powers, Thomas R Fleming, Judith A Siuciak, John Bradley, Helen Boucher; CABP-ABSSSI Project Team
Collaborators, Affiliations
Review

Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health

George H Talbot et al. Clin Infect Dis. 2012 Oct.

Abstract

Efficacy endpoints for previous registrational trials of antimicrobials for acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP) were based on nonstandardized, clinician-based observations and decisions, as well as on patient reports. More quantifiable, reproducible, and externally verifiable endpoints could improve the design of future noninferiority trials. At the request of the Food and Drug Administration, the Foundation for the National Institutes of Health convened a broadly representative scientific project team to evaluate potential endpoints for such registrational trials. Review of historical and modern data led to the conclusion that antimicrobial treatment effects are most apparent early in therapy; later outcomes provide important supportive information. Although evidence is incomplete, early response endpoints can anchor noninferiority hypotheses in ABSSSI and CABP registrational trials, thereby allowing evidence-based drug development to continue. Further research is underway to establish which short- and long-term outcomes are well-defined, reliable, and reflective of how patients feel, function, or survive.

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Figures

Figure 1.
Figure 1.
Duration of symptoms in patients with pneumococcal pneumonia [21].
See this image and copyright information in PMC

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References

    1. US Food and Drug Administration, Center for Drug Evaluation. Guidance for industry: acute bacterial skin and skin structure infections: developing drugs for treatment. 2010 Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati... . Accessed 4 March 2012.
    1. US Food and Drug Administration, Center for Drug Evaluation. Guidance for industry: community-acquired bacterial pneumonia: developing drugs for treatment. 2009 Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformati... . Accessed 4 March 2012.
    1. Foundation for the National Institutes of Health Biomarkers Consortium Project Team. Recommendations to FDA for interim endpoints for clinical trials in acute bacterial skin and skin structure infections. Available at: http://www.regulations.gov/#!docketDetail;rpp=10;po=0;D=FDA-2010-D-0433T . Accessed 4 March 2012.
    1. Foundation for the National Institutes of Health Biomarkers Consortium Project Team. Recommendations to FDA for interim endpoints for clinical trials in community-acquired bacterial pneumonia. Available at: http://www.regulations.gov/#!docketDetail;rpp=10;po=0;D=FDA-2009-D-0136 . Accessed 4 March 2012.
    1. Powers JH. Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs. Clin Infect Dis. 2007;45:S153–62. - PubMed

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