Evidence map›Paper›PMID 29177461›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

Rigorous Clinical Trial Design in Public Health Emergencies Is Essential.

Susan S Ellenberg, Gerald T Keusch, Abdel G Babiker, Kathryn M Edwards, Roger J Lewis, Jens D Lundgren, Charles D Wells, Fred Wabwire-Mangen, Keith P W J McAdam

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Evaluation of Salivary Biomarkers of Periodontal Disease Based on Smoking Status: A Systematic Review.International journal of environmental research and public health · 2022
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Article
  7. Article
  8. Monitoring clinical trials in infectious diseases.Journal of allergy and infectious diseases · 2021
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. COVID-19: Coagulopathy, Risk of Thrombosis, and the Rationale for Anticoagulation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
  14. Article
  15. Evidence-Based Practical Guidance for the Antithrombotic Management in Patients With Coronavirus Disease (COVID-19) in 2020.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Susan S EllenbergDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Gerald T KeuschDepartments of Medicine and Global Health, Boston University Schools of Medicine and Public Health, Massachusetts.
Abdel G BabikerMedical Research Council Clinical Trials Unit, University College London, United Kingdom.
Kathryn M EdwardsDepartment of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee.
Roger J LewisDepartment of Emergency Medicine, Harbor-UCLA Medical Center, University of California, Los Angeles, California.
Jens D LundgrenDepartment of Infectious Diseases, University of Copenhagen, Denmark.
Charles D WellsInfectious Diseases Unit, Sanofi-US, Bridgewater, New Jersey.
Fred Wabwire-MangenDepartment of Epidemiology, Makerere University School of Public Health, Kampala, Uganda.
Keith P W J McAdamDepartment of Clinical and Tropical Medicine, London School of Hygiene and Tropical Medicine, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomized clinical trials are the most reliable approaches to evaluating the effects of new treatments and vaccines. During the 2014-2015 West African Ebola epidemic, many argued that such trials were neither ethical nor feasible in an environment of limited health infrastructure and severe disease with a high fatality rate. Consensus among the numerous organizations providing help to the affected areas was never achieved, resulting in fragmented collaboration, delayed study initiation, and ultimately failure to provide definitive evidence on the efficacy of treatments and vaccines. Randomized trials were in fact approved by local ethics boards and initiated, demonstrating that randomized trials, even in such difficult circumstances, are feasible. Improved planning and collaboration among research and humanitarian organizations, and affected communities, in the interepidemic periods are needed to ensure that questions regarding the efficacy of vaccines and treatments can be definitively answered during future public health emergencies.

Indexed as

Disease OutbreaksEmergenciesEthics, ResearchPublic HealthAfrica, WesternControl GroupsHemorrhagic Fever, EbolaHumansRandomized Controlled Trials as TopicResearch Design

Identifiers

PMID29177461
PMCPMC5905619

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.