Protas’ trial technology platform, Cantata, has been chosen to deliver the largest-ever dengue therapeutics trial, in search for safe, effective, affordable treatments.
Cantata, Protas’ unified, end-to-end clinical trial platform will power DEN-HOST: a randomised, adaptive phase 3 trial to evaluate therapeutics in patients with moderate or severe dengue – the world’s largest dengue treatment trial to date.
Cantata was built based on decades of expertise in designing and delivering practice-changing clinical trials, to help bring better treatments to patients faster, at a lower cost and with greater confidence.
Previous use of the platform has been associated with 40% faster study start-up and a 75% reduction in monitoring costs.
The DEN-HOST trial is preparing to recruit its first patients in the search for safe, effective and affordable treatments for dengue, which affects 400 million people and causes 40,000 deaths per year, but currently has no licensed therapies.
DEN-HOST aims to change this by generating reliable evidence about treatments that could be used in countries affected by dengue.
It is a phase 3, multi-site, placebo-controlled, randomised adaptive trial being delivered through a collaboration between Oxford University’s Pandemic Sciences Institute (PSI), the Programme for Research in Epidemic Preparedness and REsponse (PREPARE) under the Communicable Diseases Agency in Singapore, and the Oxford University Clinical Research Unit (OUCRU), with funding from Wellcome.
Initially, it will launch in Asia and Latin America and will evaluate three existing medicines – baricitinib, dexamethasone and N-acetylcysteine – with the aim of expanding to further regions and treatments over time. Ultimately, it aims to recruit 8,000 participants.
Cantata has been chosen to support the trial because of the trial’s innovative design.
It will allow multiple treatments to be evaluated through one platform; will evolve based on the needs of the trial; and will handle all trial activities, from recruitment and randomisation, through monitoring to follow-up.
Each stage will be configured around DEN-HOST’s requirements, delivering a seamless, end-to-end, real-time data flow from collection to analysis.
Stefan Blixen-Finecke, Chief Information Officer, Protas, said: “The ambitious and innovative design and scale of DEN-HOST makes it ideal for Cantata, which we designed and built to power large, important trials tackling the world’s most pressing health problems.
“Cantata reimagines the fragmented digital ecosystem underpinning most trials, which fails to deliver the operational and quality advantages of automation. Instead, Cantata brings people, processes and data into one unique, end-to-end system.
“By streamlining trial activities and reducing the administrative burden on sites, there’s more time to focus on patients while also generating the high-quality data needed to inform clinical decision-making and, we hope, to find the world’s first dengue treatments. We are thrilled to be working with colleagues at Oxford, PREPARE and Slalom on this exciting trial.”
Protas worked with technology partner Slalom to design and build Cantata, translating Protas’ clinical trial design and delivery expertise into scalable technology. For DEN-HOST, this will give sites across different countries a shared process for recording and managing trial information with one single data model.
Bringing these activities together allows trial teams to view recruitment, safety and data-quality information as soon as it’s recorded, reducing manual data transfer and making it easier to participate alongside routine patient care.
Davi Quintiere, Managing Director – Health and Life Sciences, Slalom said: “Cantata being selected to support DEN-HOST is a significant moment in demonstrating how streamlined, scalable technology can deliver important, innovative global trials.
“Protas designed Cantata around how high-quality trials should work, and at Slalom we helped to turn the model into something that could scale across countries, teams and trials.
“We’ve embedded the platform into real-world operations by bringing together technology and processes, so it actually works for the people using it – resulting in less fragmented work, a lower burden on clinical teams and faster progress to improve care in this trial and those in the future.”
Sophie Yacoub, Professor of Infectious Diseases and Chief Investigator of DEN-HOST trial, Pandemic Sciences Institute, University of Oxford, said: “Dengue is a significant public health problem in many parts of the world, but currently there is no effective treatment.
“Our primary aim is to find therapeutics for patients hospitalised with dengue, to prevent disease progression and improve outcomes for those most at risk, thereby also reducing the substantial burden on health systems in dengue endemic regions.
“To do this, DEN-HOST requires an extensive global network of collaborators, often in regions where resources are more limited.
“We required a technology platform and strategic partner which could deliver DEN-HOST at scale and enable its innovative design, including its platform and adaptive capabilities. We are delighted to have found this partnership in Protas and Slalom, and we look forward to working together in pursuit of the first effective treatment for dengue.”