The Innovative Medicines Initiative (IMI), now the Innovative Health Initiative (IHI), funds promising projects across Europe to turn health research into real benefits for patients and society. However, many of these initiatives struggle to maintain impact once EU funding ends. Despite general recognition of the need for financial and organisational sustainability, there is a lack…
The success of multinational pediatric clinical trials depends on efficient, high-quality, and scalable trial support services. From 2018 to 2025, the conect4children (c4c) network – a public-private partnership funded by the Innovative Medicines Initiative 2 – brought together 10 pharmaceutical companies and 33 academic and third-sector organizations to develop such services across 220+ sites in…
Pediatric clinical research, especially in rare diseases, faces persistent challenges including the identification and recruitment of eligible patients, assessing protocol feasibility, and ensuring efficient trial execution. These issues are compounded by small, age-stratified populations and fragmented clinical data. Real-world data (RWD), especially when drawn from electronic health records (EHRs), present an opportunity to support innovative…
Randomized controlled trials remain the gold standards for generating new novel medical evidence. To be meaningful the evidence generated must be generalizable to the real-world population. The generalisability of a trial is partially determined by its population representativeness, which measures the coverage of the trial participants within the real-world patient population.
The primary and secondary use of data in healthcare, policymaking, research and innovation depends on data sharing. Data sharing benefits from data standards that describe how data is structured so that multiple users can access and analyse the data. Data standards play a pivotal role in facilitating the reuse of data in healthcare, policymaking, research…
The concept of semantic interoperability is becoming increasingly important in the health and research fields, particularly in areas where data is scarce and precious such as rare and paediatric diseases. As Information Technology plays an ever increasing role in both healthcare and clinical research, it can act as an enabler to more efficient and standardized…
In April 2024, Members of the European Parliament (MEPs) approved the creation of the European Health Data Space (EHDS). The EHDS aims to improve citizens’ access to and control over their electronic health data for primary (healthcare) and secondary (clinical research) uses. Anticipating the endorsement of the EHDS Regulaon, c4c held a workshop in February…
Workshop Aims and Objectives: Explore how to increase alignment of conect4children (an IMI2 initiative that was established to overcome the many barriers to the planning and delivery of effective and efficient paediatric clinical trials) with the European Health Data Space and policy making in a European context. Main aims: – To gain a better understanding…
The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and reusability of paediatric clinical trial data is challenging due to a lack of standardization. The Clinical Data Interchange Standards Consortium (CDISC) standards that are required or recommended for regulatory…
Despite global efforts to improve paediatric clinical trials, significant delays continue in paediatric drug approvals. Collaboration between research networks is needed to address these delays. This paper is a first step to promote interoperability between paediatric networks from different jurisdictions by comparing drivers for, and content of, metrics about clinical trial conduct. To read full…
