ArticlePloS one2018
Performance of different clinical trial designs to evaluate treatments during an epidemic.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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
10 citing papers in PubMed.
- Past, present, and future of Phase 3 vaccine trial design: rethinking statistics for the 21st century.Clinical and experimental immunology · 2025Review
- Non-static framework for understanding adaptive designs: an ethical justification in paediatric trials.Journal of medical ethics · 2022Article
- Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials.Pharmaceutical statistics · 2022Article
- 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 · 2022Article
- Quantifying Efficiency Gains of Innovative Designs of Two-Arm Vaccine Trials for COVID-19 Using an Epidemic Simulation Model.Statistics in biopharmaceutical research · 2022Article
- Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials: so much work, so many lost opportunities.BMC medical research methodology · 2021Article
- How achievable are COVID-19 clinical trial recruitment targets? A UK observational cohort study and trials registry analysis.BMJ open · 2020Observational
- Medical research during the COVID-19 pandemic.World journal of clinical cases · 2020Review
- Review
- Outbreak science: recent progress in the detection and response to outbreaks of infectious diseases.Clinical medicine (London, England) · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
In the 2013-2016 west Africa outbreak of Ebola Virus Disease (EVD), most of the planned clinical trials failed to reach a conclusion within the time frame of the epidemic. The performance of clinical trial designs for the evaluation of one or more experimental treatments in the specific context of an ongoing epidemic with changing case fatality rates (CFR) and unpredictable case numbers is unclear. We conduct a comprehensive evaluation of commonly used two- and multi-arm clinical trial designs based on real data, which was recorded during the 2013-16 EVD epidemic in west Africa. The primary endpoint is death within 14 days of hospitalization. The impact of the recruitment start times relative to the time course of the epidemic on the operating characteristics of the clinical trials is analysed. Designs with frequent interim analyses with the possibility of early stopping are shown to outperform designs with only a single analysis not only in terms of average time to conclusion and average sample size, but also in terms of the probability of reaching any conclusion at all. Historic control designs almost always result in substantially inflated false positive rates, when the case fatality rate changes over time. Response-adaptive randomization may be a compromise between the goal of scientific validity and the ethical goal of minimizing the number of patients allocated to ineffective treatments.
Indexed as
Identifiers
What OpenQuestion holds
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.