Trial reportThe Journal of infectious diseases2016
Design of a Randomized Controlled Trial for Ebola Virus Disease Medical Countermeasures: PREVAIL II, the Ebola MCM Study.
Trial report in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 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
22 citing papers in PubMed.
- A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.The New England journal of medicine · 2016Trial
- Targeting the lethal weakness of SFTSV: Latest advances in antiviral strategies and immune prevention.iScience · 2026Review
- Innovation in the Design of Clinical Trials for Infectious Diseases: Focusing on Patients Over Pathogens.Pharmaceutical medicine · 2025Review
- Understanding Ethical Concerns Involving Vulnerable Human Participant Populations in Medical Research: Mixed-Method Analysis of Liberian Ebola Survivors' Experiences in PREVAIL I-VII.Healthcare (Basel, Switzerland) · 2024Article
- Using Bayesian statistics in confirmatory clinical trials in the regulatory setting: a tutorial review.BMC medical research methodology · 2024Review
- Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries.Wellcome open research · 2023Article
- Learning in times of stress: Lessons from COVID-19 that will last throughout this century.European journal of internal medicine · 2022Article
- Urgently seeking efficiency and sustainability of clinical trials in global health.The Lancet. Global health · 2021Review
- Machine learning for clinical trials in the era of COVID-19.Statistics in biopharmaceutical research · 2020Article
- Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19.Statistics in biopharmaceutical research · 2020Article
- The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design.Annals of the American Thoracic Society · 2020Article
- Reporting of master protocols towards a standardized approach: A systematic review.Contemporary clinical trials communications · 2019Article
- The Past Need Not Be Prologue: Recommendations for Testing and Positioning the Most-Promising Medical Countermeasures for the Next Outbreak of Ebola Virus Infection.The Journal of infectious diseases · 2018Article
- A multi-source adaptive platform design for testing sequential combinatorial therapeutic strategies.Biometrics · 2018Article
- Clinical Evaluation of Ebola Virus Disease Therapeutics.Trends in molecular medicine · 2017Review
- Collaboration of the NIH and PHS Commissioned Corps in the International Ebola Clinical Research Response.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2017Article
- Considerations for Use of Investigational Drugs in Public Health Emergencies.Therapeutic innovation & regulatory science · 2017Article
- Experimental Therapies for Ebola Virus Disease: What Have We Learned?The Journal of infectious diseases · 2017Article
- Antibody therapies for the prevention and treatment of viral infections.NPJ vaccines · 2017Article
- Treating the host response to emerging virus diseases: lessons learned from sepsis, pneumonia, influenza and Ebola.Annals of translational medicine · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundUnique challenges posed by emerging infectious diseases often expose inadequacies in the conventional phased investigational therapeutic development paradigm. The recent Ebola outbreak in West Africa presents a critical case-study highlighting barriers to faster development. During the outbreak, clinical trials were implemented with unprecedented speed. Yet, in most cases, this fast-tracked approach proved too slow for the rapidly evolving epidemic. Controversy abounded as to the most appropriate study designs to yield safety and efficacy data, potentially causing delays in pivotal studies. Preparation for research during future outbreaks may require acceptance of a paradigm that circumvents, accelerates, or reorders traditional phases, without losing sight of the traditional benchmarks by which drug candidates must be assessed for activity, safety and efficacy.
methodsWe present the design of an adaptive, parent protocol, ongoing in West Africa until January 2016. The exigent circumstances of the outbreak and limited prior clinical experience with experimental treatments, led to more direct bridging from preclinical studies to human trials than the conventional paradigm would typically have sanctioned, and required considerable design flexibility.
resultsPreliminary evaluation of the "barely Bayesian" design was provided through computer simulation studies. The understanding and public discussion of the study design will help its future implementation.
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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.