ReviewThe Lancet. Infectious diseases2015
Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?
Review in The Lancet. Infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses 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
20 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.PloS one · 2017Pooled it
- Pooled it
- A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.The New England journal of medicine · 2016Trial
- Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea.PLoS medicine · 2016Trial
- Blood kinetics of Ebola virus in survivors and nonsurvivors.The Journal of clinical investigation · 2015Trial
- Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.BMC medicine · 2020Article
- A systematic literature review of the ethics of conducting research in the humanitarian setting.Conflict and health · 2020Article
- Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel.BMC medical ethics · 2019Article
- Clinicians' attitude towards a placebo-controlled randomised clinical trial investigating the effect of neuraminidase inhibitors in adults hospitalised with influenza.BMC health services research · 2018Article
- The Ebola clinical trials: a precedent for research ethics in disasters.Journal of medical ethics · 2018Article
- Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.BMC medical ethics · 2017Article
- Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.PLoS neglected tropical diseases · 2017Article
- Predicting Ebola Severity: A Clinical Prioritization Score for Ebola Virus Disease.PLoS neglected tropical diseases · 2017Article
- Contrasting academic and lay press print coverage of the 2013-2016 Ebola Virus Disease outbreak.PloS one · 2017Article
- A post hoc evaluation of a sample size re-estimation in the Secondary Prevention of Small Subcortical Strokes study.Clinical trials (London, England) · 2016Article
- Blood-Borne Pathogens: A Canadian Blood Services Centre for Innovation Symposium.Transfusion medicine reviews · 2016Article
- [Ethical and health issues posed by the recent Ebola epidemic: What should we learn?].Revista medica de Chile · 2016Article
- Drug assessment in the Ebola virus disease epidemic in west Africa.The Lancet. Infectious diseases · 2015Article
- Ebola virus disease complicated with viral interstitial pneumonia: a case report.BMC infectious diseases · 2015Article
- Be prepared: Europe needs Ebola outbreak consortium.Nature · 2015Article
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
The Ebola outbreak that has devastated parts of west Africa represents an unprecedented challenge for research and ethics. Estimates from the past three decades emphasise that the present effort to contain the epidemic in the three most affected countries (Guinea, Liberia, and Sierra Leone) has been insufficient, with more than 24,900 cases and about 10,300 deaths, as of March 25, 2015. Faced with such an exceptional event and the urgent response it demands, the use of randomised controlled trials (RCT) for Ebola-related research might be both unethical and infeasible and that potential interventions should be assessed in non-randomised studies on the basis of compassionate use. However, non-randomised studies might not yield valid conclusions, leading to large residual uncertainty about how to interpret the results, and can also waste scarce intervention-related resources, making them profoundly unethical. Scientifically sound and rigorous study designs, such as adaptive RCTs, could provide the best way to reduce the time needed to develop new interventions and to obtain valid results on their efficacy and safety while preserving the application of ethical precepts. We present an overview of clinical studies registered at present at the four main international trial registries and provide a simulation on how adaptive RCTs can behave in this context, when mortality varies simultaneously in either the control or the experimental group.
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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.