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 Dudley; Barry 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

doi:10.1093/cid/civ927

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

Medicine, Pulmonary Division

Research output: Contribution to journal › Article › peer-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 language	English (US)
Pages (from-to)	603-607
Number of pages	5
Journal	Clinical Infectious Diseases
Volume	62
Issue number	5
DOIs	https://doi.org/10.1093/cid/civ927
State	Published - 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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/cid/civ927

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Talbot, G. H., Powers, J. H., Hoffmann, S. C., Toerner, J., Talbot, G. H., Alder, J., Ariyasu, M., Barriere, S., Boucher, H., Broom, C., Brunda, M., Cammarata, S., Cimms, T., Coleman, B., Connolly, L., Cox, E. M., Dane, A., Das, A., DIxon, D., ... Wunderink, R. (2016). 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. Clinical Infectious Diseases, 62(5), 603-607. https://doi.org/10.1093/cid/civ927

Talbot, George H. ; Powers, John H. ; Hoffmann, Steven C. ; Toerner, Joseph ; Talbot, George H. ; 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. / 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. In: Clinical Infectious Diseases. 2016 ; Vol. 62, No. 5. pp. 603-607.

@article{974468086b1142ffb4e18fc23568fd7f,

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",

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.",

keywords = "Antibacterial drug development, Early clinical response, Noninferiority trial design, PRO, Patient-reported outcome",

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

note = "Publisher Copyright: {\textcopyright} 2015 The Author 2015.",

year = "2016",

month = mar,

day = "1",

doi = "10.1093/cid/civ927",

language = "English (US)",

volume = "62",

pages = "603--607",

journal = "Clinical Infectious Diseases",

issn = "1058-4838",

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Talbot, GH, Powers, JH, Hoffmann, SC, Toerner, J, Talbot, GH, Alder, J, Ariyasu, M, Barriere, S, Boucher, H, Broom, C, Brunda, M, Cammarata, S, Cimms, T, Coleman, B, Connolly, L, Cox, EM, Dane, A, Das, A, DIxon, D, Dudley, M, Eisenstein, B, Echols, R, El-Akkad, T, File, T, Fleming, TR, Follmann, D, Friedland, HD, Friedland, I, Kartsonis, NA, Kaufhold, A, Kindrick, A, Lesnick, M, Llorens, L, Loutit, J, Powers, J, Prokocimer, P, Rex, JH, Rubin, D, Slagle, A, Suffredini, A, Torres, A, Tsai, L, Wible, M & Wunderink, R 2016, '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', Clinical Infectious Diseases, vol. 62, no. 5, pp. 603-607. https://doi.org/10.1093/cid/civ927

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. / Talbot, George H.; Powers, John H.; Hoffmann, Steven C.; Toerner, Joseph; Talbot, George H.; 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.

In: Clinical Infectious Diseases, Vol. 62, No. 5, 01.03.2016, p. 603-607.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs

T2 - 2015 Update from the Biomarkers Consortium of the Foundation for the National Institutes of Health

AU - Talbot, George H.

AU - Powers, John H.

AU - Hoffmann, Steven C.

AU - Toerner, Joseph

AU - Talbot, George H.

AU - Alder, Jeff

AU - Ariyasu, Mari

AU - Barriere, Steve

AU - Boucher, Helen

AU - Broom, Colin

AU - Brunda, Michael

AU - Cammarata, Sue

AU - Cimms, Tricia

AU - Coleman, Becky

AU - Connolly, Lynn

AU - Cox, Edward M.

AU - Dane, Aaron

AU - Das, Anita

AU - DIxon, Dennis

AU - Dudley, Mike

AU - Eisenstein, Barry

AU - Echols, Roger

AU - El-Akkad, Tarek

AU - File, Thomas

AU - Fleming, Thomas R.

AU - Follmann, Dean

AU - Friedland, H. David

AU - Friedland, Ian

AU - Kartsonis, Nicholas A.

AU - Kaufhold, Achim

AU - Kindrick, Amy

AU - Lesnick, Marc

AU - Llorens, Lily

AU - Loutit, Jeff

AU - Powers, John

AU - Prokocimer, Philippe

AU - Rex, John H.

AU - Rubin, Dan

AU - Slagle, Ashley

AU - Suffredini, Anthony

AU - Torres, Antoni

AU - Tsai, Larry

AU - Wible, Michele

AU - Wunderink, Richard

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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.

AB - 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.

KW - Antibacterial drug development

KW - Early clinical response

KW - Noninferiority trial design

KW - PRO

KW - Patient-reported outcome

UR - http://www.scopus.com/inward/record.url?scp=84960172708&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84960172708&partnerID=8YFLogxK

U2 - 10.1093/cid/civ927

DO - 10.1093/cid/civ927

M3 - Article

C2 - 26668337

AN - SCOPUS:84960172708

VL - 62

SP - 603

EP - 607

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 5

ER -

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

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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