Clinical Trial Networks Working Group Member Highlight
For this edition’s Clinical Trial Network (CTN) member highlight, we’re delighted to share PREPARE’s work in how they are laying the groundwork for a rapid response during an infectious disease outbreak.
Outbreak response is a core part of the Platform for European Preparedness Against (Re-)emerging Epidemics’ (PREPARE) mission. PREPARE is an EU funded network for harmonized large-scale clinical research on infectious diseases (ID), prepared to rapidly respond to any severe ID outbreak, providing evidence for clinical management of patients and for informing public health responses.
Rapid responses require intense preparation. That’s why on May 14, 2018 PREPARE’s partners and scientific advisory board members met in Berlin to rehearse their response to an influenza pandemic in a simulated table-top exercise. Participants worked diligently in small outbreak research teams under escalating pressure to formulate and submit research plans that involved testing a (hypothetical) novel antiviral treatment for clinical effectiveness in treating patients. The exercise was designed to test PREPARE’s outbreak response plans and to identify key actions to enhance clinical research response.
From testing response plans to building to clinical research infrastructure, PREPARE is active during intra epidemic periods. They deliver multi-center, pan-European or regional clinical studies in primary, hospital and critical care settings. These studies are aimed at understanding clinical impact, risk factors, outcomes, and clinical management of infectious disease (ID) syndromes with epidemic potential.
In the event of an ID outbreak, bespoke research plans would be delivered through the research active infrastructure. This preparation would reduce the time required to leverage a clinical research response to an outbreak in Europe.
In addition to the scientific challenges, there remain many ethical, administrative, regulatory and logistic (EARL) bottlenecks to rapid clinical research deployment both in Europe and globally. Practical solutions can be developed to overcome these bottlenecks:
- Clinical study protocols can be pre-specified and pre-approved
- Regulatory and ethical approvals can be fast-tracked
- Novel clinical trial designs can accelerate evaluation of treatment interventions
- Good participatory practice with patients and local communities can ensure clinical research processes are contextually and culturally appropriate
To implement these and other solutions, strong partnerships between multiple stakeholders must be built. To that end, GloPID-R and PREPARE are co-hosting a meeting to bring the scientific community together at the upcoming “Reaching out: a meeting to advance clinical research preparedness for infectious disease outbreaks” in Brussels on September 20-21, 2018.
For more information
Clinical Trial Networks Working Group