10 years on the move together as a network
Pascale Wenger, Bern1 and all SwissPedNet member institutions3
1 Swiss Clinical Trial Organisation, coordinator SwissPedNet
What did the Swiss clinical research landscape look like ten years ago?
Pediatricians keen to conduct clinical research were observing the developments concerning clinical research infrastructures in Switzerland. For clinical trials with adult participants, Clinical Trial Units (CTUs) were founded and funded by the Swiss National Science Foundation (SNSF). In 2009, the CTUs received a national coordination center, nowadays known as the Swiss Clinical Trial Organisation (SCTO).
Pediatrics was, at that point, not integrated in these developments. Therefore, the five university children’s hospitals (Basel, Bern, Geneva, Lausanne, and Zurich) as well as the three children’s hospitals of Aarau, Lucerne, and St. Gallen reacted by joining their efforts to advocate for pediatrics in clinical research. They first met with the SCTO in February 2011 to brainstorm about starting a pediatric Swiss clinical trial network, to define needs, tasks, and ideas for this pediatric network and its relationship with the CTUs. In addition, to raise awareness for the specific needs of pediatrics, the 2nd SCTO Symposium in June 2011 was dedicated to clinical research in pediatrics. The SNSF and the Swiss University Conference (SUC) were identified as possible grant providers for funding.
In March 2012, the SNSF approved to fund the position of a Swiss coordinator for pediatric clinical research (0.7FTE) within the new SwissPedNet project, which would be hired directly by the SCTO and dedicated to all contributing pediatric sites. Unfortunately, the SUC did not provide support for local research activities within the children’s hospitals.
After the coordinator started at the SCTO in August 2012, SwissPedNet was founded in February 2013. In November later this year, its first general assembly was held. While the road to success was not easy with repeated grant applications, hopes and disappointments, we can proudly say that since 2017 SwissPedNet is recognized as a research infrastructure of national relevance and receives direct federal funding according to the Federal Act on the Promotion of Research and Innovation (RIPA art. 15).
Today, we have a lively network with many activities between all eleven member institutions.
Since the beginning, the primary goal of SwissPedNet remains unchanged: “Promote, facilitate, coordinate and conduct clinical trials devoted to children ranging from newborn to adolescent age, in all pediatric disciplines.” And this is what we do, with much commitment and joy.
Since then, the level of development of each clinical hub remains relatively heterogeneous regarding staff, activities, and contributions. However, thanks to the support of federal funds and the efforts of all involved, each year the quality and performance increases in all SwissPedNet hubs.
Key facts of SwissPedNet:
- 2013 Foundation of SwissPedNet: improving children’s health through research with the Swiss Research Network of Clinical Pediatric Hubs
- 2017 Recognized as research infrastructure of national relevance.
- 9 clinical pediatric hubs throughout Switzerland, 2 thematic platforms dedicated to registries and pediatric pharmacology
- Field Trips: networking within the network to strengthen collaboration between hubs
- A lively study activity, both local and multi-centered
- NextGen Program: an innovative training program for young pediatric clinical researchers
- Translational and Clinical Research Session during the annual conference of pédiatrie suisse since 2013
- Internationally linked and connected. Due to the small number of pediatric patients, cooperation beyond our borders is necessary. SwissPedNet is the Swiss national hub of the pan-European research infrastructure conect4children (c4c) and, since its very beginning, a member of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA).
- Successful funding applications: Research teams from SwissPedNet’s member institutions receive funds from the SNSF’s IICT funding program; e.g., KIDS-STEP, PASTA, MyTHIC.
- SwissPedNet is an association according to the Swiss civil code §§ 66 to 79 and governed by the SwissPedNet board and an international advisory board.
- The SCTO is the backbone of the SwissPedNet infrastructure. There is a close collaboration between the pediatric hubs and the SCTO’s CTU Network. The SwissPedNet Coordinator is based at the SCTO’s Executive Office.
How SwissPedNet supports and inspires our members
Ten years of SwissPedNet at the Children’s Hospital Aarau: Opportunity and challenge at the same time. A bit between worlds as a children’s hospital close to primary care with simultaneous IVHSM2 performance mandates as well as close links to the researching university hospitals. Always exciting, always something new. Thank you SwissPedNet for always keeping us on our toes.
2Intercantonal Agreement on Highly Specialized Medicine
The Basel hub can look back on a successful collaboration with SwissPedNet in the past ten years. We started in 2016 as an outpatient research center with a small team of two research nurses and a medical director. In summer 2021, the hub was renamed to Pediatric Research Center (PRC) to reflect its growth – made possible in part by the generous support of SwissPedNet. The PRC is dedicated to implementing impactful, high-quality clinical research in Basel, in Switzerland and internationally. We are an interdisciplinary team (physicians, research nurses, data managers, statisticians, regulatory experts, co-ordinators, administrative specialists, and quality officers) supporting clinical research, with input ranging from advice on regulation, contracts, and financing, through on-site management, statistics, data management to biobanking. The Basel hub leads and actively contributes to several SwissPedNet and international projects.
PedNet Bern: Ten years ago, we founded the SwissPedNet and started the PedNet Bern with a medical lead and a study nurse. Good things take time, especially in Bern! Meanwhile, SwissPedNet funding has enabled us to grow organically to a team of eight study nurses and coordinators. It has supported more than 40 studies over the last ten years. Especially, the professional exchange between hubs has been very helpful in fulfilling our mission to enhance excellent pediatric research.
The Geneva SwissPedNet Hub: What could we do thanks to SwissPedNet in the last 10 years? Many things!
- We lead and contributed to more than 100 pediatric studies which improved the care and health of children.
- We expanded and trained our staff to help more (young) pediatric researchers with their studies.
- We collaborated on several national and international studies and took part in the SwissPedNet point prevalence study, a proof of concept to evaluate data retrieval.
- We participated in teaching and learning opportunities, such as NextGen research day or at the Pédiatrie Suisse Congress.
- We integrated the network of pediatric research nurses of Switzerland and cooperated with the creation of common procedures.
Hub Lausanne: Thanks to the contribution of SwissPedNet, the Lausanne PedNet Hub began to see the light in 2018. Composed of a project manager, a study coordinator, a data entry specialist, a data manager, and a medical coordinator, the Lausanne Hub has been able to support pediatric investigators in more than 60 clinical research projects of all specialties since its creation. In parallel of this support, a pediatric general consent for research has been developed and deployed in our institution with the help of the hub. Little to say this would have not been possible without the never-failing support of SwissPedNet!
Collaboration is key to the success of clinical research projects and thanks to SwissPedNet, the pediatric clinical research network has been consistently growing and developing ever since. The relationships developed over the last years between the hubs will bring a new dynamic to successfully lead pediatric research within Switzerland.
Hub Luzern: Thanks to SwissPedNet and some basic financial support starting in 2017, the children’s hospital Lucerne (LUKS) could develop a pediatric research center which was able to grow over the past years. Starting with the hub coordinator and one study nurse, we are now a team of four, all part of the clinical nursing and physician staff team. In 2018, the CTU at LUKS was established adding further professional local research infrastructure. We started off supporting one diagnostic trial and two registries and are now a well-established and sought-after hub supporting researchers of different backgrounds in over 40 multicenter trials, cohort studies, and registries within and outside of SwissPedNet. Recently, the children’s hospital and LUKS have partnered with the Faculty of Health Sciences and Medicine at the University of Lucerne progressing into an academic and teaching institution for central Switzerland.
Hub St. Gallen: The development work for the hub at the children’s hospital of Eastern Switzerland (Ostschweizer Kinderspital, OKS) in St. Gallen began in 2018. In a first step, a kind of “layout” of the then ongoing projects took place, which were compiled in a standardized way via a web form. At that time, the high number of research projects, namely 37, astonished not only ourselves. However, it also became apparent that due to work overload the status had been practically inactive for years and that the visibility to the outside world was still very limited. The SwissPedNet funding and the support and prioritization by the hospital management allowed us to hire a person for the study coordination with a workload of 60%. This was the first step to systematically support research activities by the institution in order to be able to make a reliable contribution to research in pediatric medicine nationally and internationally. In the meantime (since 2022), three persons work for the hub. In addition to overseeing and actively supporting no less than 59 research projects, OKS is integrated into various research networks locally and nationally. Research at the OKS has become more visible. This is not only reflected in various successfully completed research projects, but also in the representation of the OKS in the research commission at the cantonal hospital St. Gallen (KSSG).
Hub Ticino: Thanks to SwissPedNet funds, we were able to employ dedicated personnel to better coordinate and promote our research activity. We participate to an increasing number of clinical trials, and the number of our scientific publications is growing. SwissPedNet meeting opportunities, allowed us to expand our research network and improve our knowledge and skills. We have the chance to participate in development and conduction of interesting multi-center research projects in collaboration with university hospitals. In the past two years, we won two junior researcher grants, which have allowed two young doctors to carry out research projects in parallel with their clinical activity.
PedNetHub Zürich: The Children’s Research Center (CRC) is a unique institution, which bundles, coordinates, and promotes the entire scientific research at the Children’s Hospital Zurich, ranging from basic research in the laboratory to clinical studies with drugs and innovative new therapies, to the development of computer- and robot-assisted movement therapies and the cultivation of human skin in the laboratory. Being part of SwissPedNet in the past ten years helped us to expand our services and to gain greater expertise, which leads to a steady increase in the quality of research at the Children’s Hospital Zurich. With the implementation of the eISF/eTMF system and the central Biobank Information Management System, we are well positioned in terms of technological progress and further cooperation with the PedNetHubs throughout Switzerland.
SwissPedPha is the national research center for quantitative pharmacology modeling and computer simulation («pharmacometrics») to inform and enhance optimal drug use in children in Switzerland. This expertise has supported off-label drug development with respect to optimal pediatric study design and/or data analysis, to maximize pediatric pharmacology information gained from clinical SwissPedNet studies. In recent years, SwissPedPha formed together with other clinical-academic institutions an independent, national expert team closely collaborating with the Swiss Database for Dosing Medicinal Products in Pediatrics (SwissPedDose). This expert team provided a quantitative, scientific rationale facilitating dose optimization and harmonization for various therapeutics such as amoxicillin, amikacin, or metamizole prescribed in neonates, infants, and older children by performing computer simulations (also called in silico studies) complementing data from clinical studies.
SwissPedRegistry is a research platform for pediatric medical registries that provides expertise for the increasing number of registries and cohort studies in Switzerland. It counsels registries, promotes the interests of registry stakeholders, develops methods and instruments, and hosts registries. Thus, SwissPedRegistry contributes to quality and efficiency of clinical registries and cohort studies in pediatrics. In addition, SwissPedRegistry was a driving force in infrastructure development for clinical research in pediatrics, leading the infrastructure development project “SwissPedData” funded by the Swiss Personalized Health Network (SPHN), which defined a harmonized dataset for electronic health records in a national Delphi process. Currently, the hub helps to implement the pediatric data stream “SwissPedHealth” in all hospitals. SwissPedHealth aims to extract, combine, and clean data from all children’s hospitals and to use the data for research and healthcare audits. All this contributes to a learning health care system, which makes pediatric data available and interoperable for research.
And where is all this leading us?
During our general assembly we continued to plan the future. We were able to expand our network and gain a new member: As of 2023 Fribourg will be our tenthhub. The cantonal hospital of Fribourg (Hôpital Cantonal Fribourgeois) is continuously building up its clinical research activity in pediatrics and we look forward to supporting it and to increasing the number of our partners for multi-center studies.
Relying on our network we organized point prevalence studies. The goal was to accompany the implementation of SwissPedData by testing the interdependent functioning of individual hubs and the process of data retrieval within all (different) clinical information systems. The first was performed in October 2022 about perioperative measures for surgical site infection prevention in pediatric surgery in Switzerland. The second will follow in 2023 and will target the prevalence of traumatic brain injuries in children treated in Swiss children’s hospitals. The first experience provided many new strategies to improve interoperability for other studies in the future.
As we are increasingly recognized as a trusted research network, we are involved in the activities of SPHN and continue to support SwissPedHealth, the Pediatric personalized research network Switzerland – a Joint Pediatric National Data Stream led by Luregn Schlapbach, University Children’s Hospital Zurich, and Julia Vogt, ETH Zurich.
We continue with the training of the next generation of pediatric clinical researchers with our program “NextGen Research Days”. Our well-established translational and clinical research session will become part of the NextGen Program held for the first time in a new format in 2023. Keep your eyes open and be part of it in June in Interlaken!
We continue to strengthen our network with further events for our hub staff. They work together on projects to harmonize processes, and we all get together during the Field Trips. In 2023, the field trips will be hosted by SwissPedPha and the hub Luzern.
We are confident that all of this will lead us to a bright future of high-quality clinical research in pediatrics.
We thank our funding bodies: the SNSF, which was the ignition to run the engine, the Swiss Academy of Medical Sciences, which provided means to start the first activities, the State Secretariat for Education, Research and Innovation, which recognized us as a reliable research infrastructure, and the SCTO, for their ongoing support and collaboration.
c/o Swiss Clinical Trial Organisation
www.swisspednet.ch / firstname.lastname@example.org
3The SwissPedNet member institutions and representatives:
Children’s hospital Aarau, Henrik Köhler, Csongor Deak; University Children’s Hospital of Basel, Julia Bielicki, Ulrich Heininger; University Children’s Hospital Bern, Philipp Agyeman, Rahel Kuonen; university children’s hospital Geneva, Patrick Petignat, Klara Posfay Barbe; university children’s hospital Lausanne, François Angoulvant, Manuel Diezi; children’s hospital Luzern, Michael Büttcher; children’s hospital of Eastern Switzerland, St. Gallen, Christian Kahlert, Roger Lauener; children’s hospital of the EOC Ticino, Barbara Goeggel Simonetti, Giacomo Simonetti; University Children’s Hospital Zurich, Matthias Baumgartner, Patrick Meyer Sauteur; SwissPedRegistry, Institute of Social and Preventive Medicine, University of Bern, Claudia Kühni; SwissPedPha, Swiss platform for pediatric clinical pharmacology services, Marc Pfister, Johannes van den Anker