Real-World Evidence for Decisions in Diabetes

REDDIE First Progress Meeting at Novo Nordisk Favrholm Campus: Integrating Real-World Data for Diabetes Research

The REDDIE project (Real-world Evidence for Decisions in Diabetes) aims to enhance randomised controlled trials with real-world data from diabetes databases. The consortium, which consists of 16 partners from 9 countries, met in Denmark from 22 to 23 April to discuss the progress of the project in its first year. Around 40 consortium members gathered in person and online.

The meeting focussed on enhancing clinical trial data with real-world evidence (RWE) and synthetic data, promoting stakeholder engagement and refining methodologies crucial for the success of the project.

Project coordinator Dr Julia Mader from the Medical University of Graz opened the meeting with a warm welcome together with Dr Matthias Müllenborn from the meeting host institution Novo Nordisk. Martina Radanović from RISE began with an overview of the project management and a plan for the next steps to be achieved this year.

The REDDIE methodology, which aims to use real-world data to enhance the efficacy, safety and value of diabetes prevention and treatment technologies, was a focus of the discussions. The partners explored how real-world evidence can complement traditional RCTs to produce more robust results. Work package 2, led by Dr Pratik Choudhary from the Leicester Diabetes Centre, kicked things off, aiming to identify diabetes databases and the metadata they contain. The discussion led by Dr Pratik Choudhary and Jonah Thomas focused on the identification of diabetes databases and the creation of database guidelines.

Subsequent sessions centred on work packages 3 and 5. Work package 3, led by Prof Amanda Adler from the University of Oxford, focused on identifying the needs of regulators and payers to determine the effectiveness and cost-effectiveness of diabetes interventions, with an emphasis on the use of synthetic data. Work package 5, led by the University of Padua, presented advanced methodological approaches for integrating real-world and virtual evidence into clinical trials presented by Enrico Longato. Day 1 ended with work package 8 focused on ethics requirements after which the partners gathered for a nice dinner, informal conversations and networking.

The second day started with an update from work package 4 led by Prof Christian Torp-Pedersen and the team at the Nordsjællands Hospital Hillerød that delved into methods of validating RWE against Randomized Controlled Trial (RCT) evidence. Updates from representatives of the four national registries highlighted progress in analyzing real-world data sourced from population-based registries across Denmark, Germany, Sweden, and the UK.

Discussions within work package 6 presented by Dr Julia Mader underscored the significance of involving stakeholders early in the process to gain diverse viewpoints essential for informed decision-making. The emphasis on stakeholder engagement aims to ensure that the project aligns closely with the needs and expectations of all involved parties. The last session before the wrap-up was centred around the project communication, dissemination and exploitation led by EURICE and Dr Chiara Lonoce.

The day ended with a Steering Committee meeting, where work package leaders converged to set the trajectory of the project for success. The comprehensive review and detailed planning during this session are integral to steering the project on the right path.

The meeting once again proved the importance of in-person meetings where partners can easily collaborate, solve some open questions and define clear next steps. The next REDDIE progress meeting will be held in Italy in 2025 and hosted by the University of Padova.