Pharmacokinetics of TKM-130803 in Sierra Leonean patients with Ebola virus disease: plasma concentrations exceed target levels, with drug accumulation in the most severe patientsby Janet T. Scott, Raman Sharma, Luke W. Meredith, Jake Dunning, Catrin E. Moore, Foday Sahr, Steve Ward, Ian Goodfellow, Peter Horby, RAPIDE-TKM Trial Team
A systematic review and meta-analysis of patient data from the West Africa (2013–16) Ebola virus disease epidemicby Alex Salam, Delphine Kayem, Lyndsey Castle and Peter Horby
A rapid research needs appraisal methodology to identify evidence gaps to inform clinical research priorities in response to outbreaks—results from the Lassa fever pilotby Louise Sigfrid, Alex Salam and Peter Horby
Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panelby Peter Horby
Comparative Outcomes of Adults Hospitalized With Seasonal Influenza A or B Virus Infection: Application of the 7-Category Ordinal Scale.by Peter Horby
Priorities, Barries, and Facilitators towards International Guidelines for the Delivery of Supportive Clinical Care during an Ebola Outbreak: A Cross-Sectional Surveyby Alex Salam, Peter Horby
Prolonged Evolution of Virus-Specific Memory T Cell Immunity after Severe Avian Influenza A (H7N9) Virus Infectionby Peter Horby
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. 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
Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutionsby Alex Salam, Amanda Rojek, Jake Dunning, Peter Horby
This article evaluates the major challenges in choosing therapeutics to prevent congenital ZIKV disease and conducting clinical trials of these treatments, with a focus on preventing congenital central nervous system malformations. This article was first published in Annals of Internal Medicine.
This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. This article was first published in PLOS.
With video. Results of the Wellcome Trust funded trial of the experimental anti-Ebola drug TKM-130803 have been published in PLoS Medicine. Using a novel approach designed to get rapid indications of a drug’s effectiveness, the trial showed that at the dose given the drug did not improve survival compared to historic controls.
Charvy Narain describes how Oxford medics found themselves on the front line
This article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. The paper was published in Clinical Trials.