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Biomarkers and surrogate endpoints in clinical trials

Statistics in medicine, 2012-11, Vol.31 (25), p.2973-2984

2012

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Inappropriate empirical antibiotic therapy for bloodstream infections based on discordant in-vitro susceptibilities: a retrospective cohort analysis of prevalence, predictors, and mortality risk in US hospitals

The Lancet infectious diseases, 2021-02, Vol.21 (2), p.241-251

2021

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Association Between Caseload Surge and COVID-19 Survival in 558 U.S. Hospitals, March to August 2020

Annals of internal medicine, 2021-09, Vol.174 (9), p.1240-1251

2021

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Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022

Scientific reports, 2024-02, Vol.14 (1), p.3325-3325, Article 3325

2024

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Improving the Evidence for New Interventions in Infectious Diseases: Refocusing on Patients Instead of Pathogens and Direct Evidence for Added Patient Benefits

Clinical infectious diseases, 2021-06, Vol.72 (11), p.1975-1978

Powers, John H

2021

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Difficult-to-Treat Resistance in Gram-negative Bacteremia at 173 US Hospitals: Retrospective Cohort Analysis of Prevalence, Predictors, and Outcome of Resistance to All First-line Agents

Clinical infectious diseases, 2018-11, Vol.67 (12), p.1803-1814

2018

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Clinical Outcome Assessments: Conceptual Foundation—Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force

Value in health, 2015-09, Vol.18 (6), p.741-752

2015

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Needs assessment for novel Gram-negative antibiotics in US hospitals: a retrospective cohort study

The Lancet infectious diseases, 2020-10, Vol.20 (10), p.1172-1181

2020

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Evaluation of Antihemagglutinin and Antineuraminidase Antibodies as Correlates of Protection in an Influenza A/H1N1 Virus Healthy Human Challenge Model

mBio, 2016-04, Vol.7 (2), p.e00417-e00416

2016

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Procalcitonin-Guided Antibiotic Discontinuation and Mortality in Critically Ill Adults: A Systematic Review and Meta-analysis

Chest, 2019-06, Vol.155 (6), p.1109-1118

2019

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Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)

Clinical infectious diseases, 2015-09, Vol.61 (5), p.800-806

2015

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Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

The Journal of infectious diseases, 2019-05, Vol.219 (10), p.1536-1544

2019

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Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

Value in health, 2017, Vol.20 (1), p.2-14

2017

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Cefiderocol and the Need for Higher-Quality Evidence: Methods Matter for Patients

Antimicrobial agents and chemotherapy, 2022-08, Vol.66 (8), p.e0076622-e0076622

2022

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Effect of 7 vs 14 Days of Antibiotics Among Afebrile Men With Urinary Tract Infection

JAMA : the journal of the American Medical Association, 2021-11, Vol.326 (20), p.2079

2021

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World Health Organization Ranking of Antimicrobials According to Their Importance in Human Medicine: A Critical Step for Developing Risk Management Strategies for the Use of Antimicrobials in Food Production Animals

Clinical infectious diseases, 2009-07, Vol.49 (1), p.132-141

2009

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Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation

Value in health, 2020-02, Vol.23 (2), p.227-235

2020

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Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective

Value in health, 2007-11, Vol.10, p.S125-S137

2007

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Trends in Antimicrobial Drug Development: Implications for the Future

Clinical infectious diseases, 2004-05, Vol.38 (9), p.1279-1286

2004

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Factor Analysis in Distinguishing Coronavirus Disease 2019 From Other Influenza-like Illness Using a Validated Patient-Reported Outcome Instrument FLU-PRO Plus: A Prospective Real-world Cohort Study

Medical care, 2023-05, Vol.61 (5), p.288-294

2023

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Using the Influenza Patient-reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model

BMC infectious diseases, 2018-07, Vol.18 (1), p.353-9, Article 353

2018

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Fluoroquinolone-Resistant Campylobacter Species and the Withdrawal of Fluoroquinolones from Use in Poultry: A Public Health Success Story

Clinical infectious diseases, 2007-04, Vol.44 (7), p.977-980

2007

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The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age

Influenza and other respiratory viruses, 2024-02, Vol.18 (2), p.e13236-n/a

2024

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External Validation of Difficult-to-Treat Resistance Prevalence and Mortality Risk in Gram-Negative Bloodstream Infection Using Electronic Health Record Data From 140 US Hospitals

Open forum infectious diseases, 2019-04, Vol.6 (4), p.ofz110

2019

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A Comparative Assessment of Approvals and Discontinuations of Systemic Antibiotics and Other Therapeutic Areas

Healthcare (Basel), 2023-06, Vol.11 (12), p.1759

2023

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Biomarkers and surrogate endpoints in clinical trials

Inappropriate empirical antibiotic therapy for bloodstream infections based on discordant in-vitro susceptibilities: a retrospective cohort analysis of prevalence, predictors, and mortality risk in US hospitals

Association Between Caseload Surge and COVID-19 Survival in 558 U.S. Hospitals, March to August 2020

Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022

Improving the Evidence for New Interventions in Infectious Diseases: Refocusing on Patients Instead of Pathogens and Direct Evidence for Added Patient Benefits

Difficult-to-Treat Resistance in Gram-negative Bacteremia at 173 US Hospitals: Retrospective Cohort Analysis of Prevalence, Predictors, and Outcome of Resistance to All First-line Agents

Clinical Outcome Assessments: Conceptual Foundation—Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force

Needs assessment for novel Gram-negative antibiotics in US hospitals: a retrospective cohort study

Evaluation of Antihemagglutinin and Antineuraminidase Antibodies as Correlates of Protection in an Influenza A/H1N1 Virus Healthy Human Challenge Model

Procalcitonin-Guided Antibiotic Discontinuation and Mortality in Critically Ill Adults: A Systematic Review and Meta-analysis

Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)

Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

Cefiderocol and the Need for Higher-Quality Evidence: Methods Matter for Patients

Effect of 7 vs 14 Days of Antibiotics Among Afebrile Men With Urinary Tract Infection

World Health Organization Ranking of Antimicrobials According to Their Importance in Human Medicine: A Critical Step for Developing Risk Management Strategies for the Use of Antimicrobials in Food Production Animals

Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation

Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective

Trends in Antimicrobial Drug Development: Implications for the Future

Factor Analysis in Distinguishing Coronavirus Disease 2019 From Other Influenza-like Illness Using a Validated Patient-Reported Outcome Instrument FLU-PRO Plus: A Prospective Real-world Cohort Study

Using the Influenza Patient-reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model

Fluoroquinolone-Resistant Campylobacter Species and the Withdrawal of Fluoroquinolones from Use in Poultry: A Public Health Success Story

The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age

External Validation of Difficult-to-Treat Resistance Prevalence and Mortality Risk in Gram-Negative Bloodstream Infection Using Electronic Health Record Data From 140 US Hospitals

A Comparative Assessment of Approvals and Discontinuations of Systemic Antibiotics and Other Therapeutic Areas

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