Novadiscovery announces Nature Communications paper on modeling the disruption to respiratory clinical trials due to mitigation measures against COVID-19
Model uses virtual populations and in silico trials to show impact on clinical trials and suggest adaptations to trial design
Lyon, France - 13 April 2022: Novadiscovery (NOVA), a leading health tech company using in silico clinical trials to predict drug efficacy and optimize clinical trial development, today announces the publication of a novel model of respiratory tract infections (RTI) in Nature Communications to address the uncertainties resulting from non-pharmaceutical interventions (NPIs) against COVID-19 on clinical trials. The paper was published in collaboration with NOVA's partner OM Pharma.
François-Henri Boissel, CEO, NOVA said: "The pandemic and all related measures such as lockdowns seriously affected clinical trials in all indications but the impact of reduced viral transmission and resulting seasonal disease pattern disruption on respiratory trials was particularly marked. Our model provides vital information on whether trials will still meet their endpoints, how to interpret clinical relevance, and potential adaptations to statistical analyses and trial design - such as recruitment numbers - to maximise success and avoid delays in getting new treatments to patients."
NOVA's modeling approach is rooted in systems biology and quantitative systems pharmacology. The paper describes how the model was used to run in silico clinical trial simulations with OM Pharma's OM-85 as prophylaxis for respiratory tract infection (RTI) in virtual populations and under various scenarios of reduced viral transmissions due to NPIs.
The results have led the paper's authors to advocate for reporting varying metrics of benefit, the use of adaptive trial design and adapted statistical analyses. The authors also warned that eligibility criteria for patients into trials will need to be reassessed as disease burden has been impacted by pandemic measures.
The full paper, 'Modeling the disruption of respiratory disease clinical trials by non-pharmaceutical COVID-19 interventions', can be found here.
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For more information, please contact:
Novadiscovery
François-Henri Boissel, Chief Executive Officer
Email: contact@novadiscovery.com
Consilium Strategic Communications
Sukaina Virji, Kris Lam, Isabelle Abdou
Email: novadiscovery@consilium-comms.com
About Novadiscovery
Novadiscovery is a leading health tech company using in silico clinical trials to predict drug efficacy and optimize clinical trial development. The Company aims to improve R&D productivity and maximize patient outcomes by predicting the clinical benefit of a potential new drug candidate through computer simulation, ahead of human trials.
Novadiscovery's innovative approach leverages disease modeling and simulation expertise accumulated over the past decade and combines mathematical models of diseases and potential new treatments with virtual patients in its integrated clinical trial simulation platform, JINKO.
Novadiscovery is headquartered in Lyon, France and has a team of around 30 scientists, engineers & clinicians who work at the interface of biology, pharmacology, mathematics & computer science.
For more information, please visit https://www.novadiscovery.com and follow us on Twitter @novadiscovery and linkedin.com/company/novadiscovery
