The Future of COMBACTE: A Reflection Over the Years

Marc Bonten & Herman Goossens, 2018: “If we fail to put the infrastructure that’s been built to good use, we’ll have a divestment of value to answer for”.

Marc Bonten & Herman Goossens, 2021: “These networks had been so far performing clinical trials on demand. Through ECRAID we will set up our own perpetual observational studies. The type of studies we used to do will be brought into these perpetual observational studies. Instead of being responsive, we will become pro-active and prepared”.

Marc Bonten & Herman Goossens, 2018: “The working group is hoping to receive EU funding to develop a sustainable business model for clinical research of Infectious Diseases in Europe, built on COMBACTE and PREPARE”.

Marc Bonten & Herman Goossens, 2021: “The making-of-the-business-plan was funded through ECRAID-Plan and will be finalized in June 2021. What we can expect is clear guidance on how we can build such a sustainable infrastructure in Europe, including the services we will provide to efficiently run clinical trials. Services such as governance structure, data flow, data sharing, data governance or communication plan”.

Marc Bonten & Herman Goossens, 2018: “In 2018, we should start designing and subsequently build an ambitious infrastructure on tack­ling AMR as well as other infectious disease threats. We will never be in such a privileged and pivotal decision point in our lifetimes ever again”.

Marc Bonten, 2021: “Having the infrastructure from the networks built in COMBACTE and PREPARE put us in a privileged position back in 2018. Another advantage was the governments’ recognition of the relevance of the antimicrobial resistance (AMR) issue.

The societal significance of this infrastructure has only become larger due to COVID-19, which emphasizes the relevance of emerging infectious diseases (EID). Receiving the funding for ECRAID-Base followed from the recognition that a clinical trial network with AMR and EID at its core is fundamental”.

Herman Goossens, 2021: “We spent all these years investing in training sites, laboratories, and their staff. That gives us a very privileged position indeed to build upon, to capitalize on what we’ve done in over eight years. Now more than ever we realize the urgency of investing in infectious diseases and running clinical trials”.

Marc Bonten & Herman Goossens, 2018: “This initiative, which sounds so logical it’s practically self-evident, is nothing less than a game-changer”.

Marc Bonten & Herman Goossens, 2021: “Preparedness is the game changer. REMAP-CAP is the best example of showing that an adaptive platform trial really is the future of clinical trials. We are moving from rigid, lengthy trials to very flexible platforms that can be adapted and can provide information faster. During the COVID-19 pandemic we did not have time to run studies that take a standard four years. ECRAID will deliver the infrastructure to have more of such adaptive platform trials. Participating patients will be treated according to best practices, as quick as possible”.

Marc Bonten & Herman Goossens, 2018: “Such an infrastructure would be the only one of its kind in the world. It puts Europe in a position to take on a leadership role in infectious diseases’ clinical research”.

Marc Bonten & Herman Goossens, 2021: “What sets ECRAID apart is the collaboration between clinical sites, primary care, long-term care, pediatric care and laboratories. It’s a holistic approach of clinical research and infectious diseases, not to forget the research institutions and the research laboratories. Having a sustainable organization gives us a more official position to start up clinical trials for EID or AMR”.

Marc Bonten & Herman Goossens, 2018: “A permanent and leading European clinical trial network will be in place from 1 January 2022”.

Marc Bonten, 2021: “ECRAID-Base starts on March 1^st, 2021. In the coming years we aim to transfer the perpetual observational studies in ECRAID to adaptive platform trials”.

Herman Goossens, 2021: “If we are recognized by the public and the private sector as being a reliable part of clinical research that will help to make us sustainable”.

Marc Bonten & Herman Goossens, 2018: “ECRAID will not only consist of a collaboration between the COMBACTE and PREPARE, but other networks of primary care, long-term care, pediatric care”.

Herman Goossens, 2021: “It’s an inclusive organization in which we will benefit from the competence, expertise of some of the best clinical researchers in the field of primary care, pediatrics, long-term care, and so on. By bringing those together we hope to build a solid infrastructure”.

Marc Bonten & Herman Goossens, 2018: “For COMBACTE, teaming up with PREPARE is a logical step. With antibiotic trials, the emphasis is on completing the trial quickly, while with a viral pandemic, you need to start as soon as possible. What they have in common is a need for a network of clinical sites with thoroughly trained staff in conducting trials”.

Herman Goossens, 2021: “The COVID-19 outbreak proved that a legal entity for clinical research and infectious diseases is desperately needed to coordinate the efforts being made at a national level to tackle a pandemic. Thousands of small trials were started that will not be completed. Many AMR researchers supported COVID-19 research which helped the collaboration between experts in COMBACTE and PREPARE.

A coordinated public health response in the EU was needed when the SARS epidemic hit in 2003. The takeaway here is that a similar coordinated response is needed, but in this case for clinical research and clinical trials”.