ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016
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.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Patient-reported outcome measures in community-acquired pneumonia: a systematic review of application and content validity.BMJ open respiratory research · 2019Pooled it
- Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections.Open forum infectious diseases · 2026Trial
- Early Clinical Response in Community-acquired Bacterial Pneumonia: From Clinical Endpoint to Clinical Practice.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials.BMC infectious diseases · 2019Trial
- Article
- Comparing Patient and Clinician Perceptions of Health-Related Quality of Life in Urinary Tract Infections.JAMA network open · 2026Article
- Moving Beyond Mortality: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Improving Traditional Registrational Trial End Points: Development and Application of a Desirability of Outcome Ranking End Point for Complicated Urinary Tract Infection Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation.Transplant infectious disease : an official journal of the Transplantation Society · 2022Review
- Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- Health-Related Quality of Life as Measured by the 12-Item Short-Form Survey Among Adults With Community-Acquired Bacterial Pneumonia who Received Either Lefamulin or Moxifloxacin in 2 Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials.Open forum infectious diseases · 2020Article
- The early change of SOFA score as a prognostic marker of 28-day sepsis mortality: analysis through a derivation and a validation cohort.Critical care (London, England) · 2019Article
- Omadacycline: A Modernized Tetracycline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.The Journal of infectious diseases · 2019Article
- The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction.Clinical pharmacology and therapeutics · 2019Article
- Patient-reported outcome measurement in community-acquired pneumonia: feasibility of routine application in an elderly hospitalized population.Pilot and feasibility studies · 2019Article
- The Role of Public-Private Partnerships in Catalyzing the Critical Path.Clinical and translational science · 2017Review
- Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Review
- Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2017Article
- Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.