Author
Listed:
- Martin Walker
(London Centre for Neglected Tropical Disease Research, Department of Pathobiology and Population Sciences, Royal Veterinary College, University of London
London Centre for Neglected Tropical Disease Research, Department of Infectious Disease Epidemiology, Imperial College London)
- Jonathan I. D. Hamley
(London Centre for Neglected Tropical Disease Research, Department of Infectious Disease Epidemiology, Imperial College London
MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London)
- Philip Milton
(London Centre for Neglected Tropical Disease Research, Department of Infectious Disease Epidemiology, Imperial College London
MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London)
- Frédéric Monnot
(Drugs for Neglected Diseases initiative, 15 Chemin Louis-Dunant 1202)
- Belén Pedrique
(Drugs for Neglected Diseases initiative, 15 Chemin Louis-Dunant 1202)
- Maria-Gloria Basáñez
(London Centre for Neglected Tropical Disease Research, Department of Infectious Disease Epidemiology, Imperial College London
MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London)
Abstract
Lymphatic filariasis and onchocerciasis are neglected tropical diseases (NTDs) targeted for elimination by mass (antifilarial) drug administration. These drugs are predominantly active against the microfilarial progeny of adult worms. New drugs or combinations are needed to improve patient therapy and to enhance the effectiveness of interventions in persistent hotspots of transmission. Several therapies and regimens are currently in (pre-)clinical testing. Clinical trial simulators (CTSs) project patient outcomes to inform the design of clinical trials but have not been widely applied to NTDs, where their resource-saving payoffs could be highly beneficial. We demonstrate the utility of CTSs using our individual-based onchocerciasis transmission model (EPIONCHO-IBM) that projects trial outcomes of a hypothetical macrofilaricidal drug. We identify key design decisions that influence the power of clinical trials, including participant eligibility criteria and post-treatment follow-up times for measuring infection indicators. We discuss how CTSs help to inform target product profiles.
Suggested Citation
Martin Walker & Jonathan I. D. Hamley & Philip Milton & Frédéric Monnot & Belén Pedrique & Maria-Gloria Basáñez, 2020.
"Designing antifilarial drug trials using clinical trial simulators,"
Nature Communications, Nature, vol. 11(1), pages 1-11, December.
Handle:
RePEc:nat:natcom:v:11:y:2020:i:1:d:10.1038_s41467-020-16442-y
DOI: 10.1038/s41467-020-16442-y
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