A critical eye on European clinical research response during COVID-19 pandemic
A new Lancet Infectious Diseases publication draws lessons from Corona crisis
22 December 2021 - Professor Herman Goossens (University of Antwerp and University Hospital of Antwerp), in collaboration with his colleagues Marc Bonten and Lennie Derde of the University Medical Centre Utrecht, and Peter Horby of the University of Oxford, casts a critical eye on how the clinical research community reacted to the pandemic in Europe in a new publication in The Lancet Infectious Diseases. What lessons were learned and what recommendations are there for the future response of clinical research during pandemics?
On 21 December, an article published in The Lancet Infectious Diseases looks back on the lessons learned, the future perspective, and the recommendations linked to the European clinical research response during the COVID-19 crisis. The goal of the paper is to optimize treatment of patients for the current and future pandemics.
In March last year, when the pandemic had just begun, multiple studies for potential COVID-19 treatments were launched. This led to a highly fragmented research landscape with few international collaborations. Contracting, regulatory hurdles and competition with and between (often inadequately designed and/or underpowered) national trials were also a major challenge in several EU countries. All these factors combined meant that by October 2021, only few studies had provided results of the required evidence level to formulate international treatment guidelines for COVID-19.
Two trials were able to respond quickly to the pandemic and provided results: RECOVERY from the UK, and REMAP-CAP that started in the EU as part of PREPARE and expanded globally. RECOVERY and REMAP-CAP differ in many aspects, but they share the randomized design, simple execution and flexibility to adjust when evidence emerges. As a result, RECOVERY and REMAP-CAP were ready to enroll their first COVID-19 patient within two and six days after the protocol was approved, respectively. The real-world experience of both platform trials during the COVID-19 pandemic clearly illustrates the key factors for success during a future pandemic.
Lessons for the future
This pandemic has shown that the search for effective interventions needs the power of scale, not several separate studies competing with each other. Therefore, the global health community should rapidly respond after this pandemic to make sure mechanisms are in place for scaling and collaboration. A European pandemic clinical research authority should be created to oversee the clinical research response and to prioritize clinical studies. This way, it is possible to move more quickly to larger, definitive trials for treatment, prevention and diagnostics during the next pandemic.
Next to that, there is the need to cooperate effectively by investing in globally connected clinical trial networks. These should be structured through platform trials and set up according to a framework of master protocols. A pandemic requires trials that rapidly answer a research question with protocols that can be executed even when a healthcare system is overwhelmed. It is obvious that such trials should be prepared during inter-pandemic periods, because success depends on existing infrastructures and governance. It also requires digital models and procedures to make data collection and data sharing easier.
"We believe that this new proposed model of clinical research will be essential for responding more effectively to future outbreaks of infectious diseases. Let's stop saying we will do better next time - we have had enough warnings. It matters now." states Professor Herman Goossens, Coordinator of PREPARE and RECOVER.