Real4Reg comprises six distinct Work Packages (WPs) that operate in close interaction from the start. These WPs will be implemented to reach the central goals of enabling the use, establishing the value, and fostering the impact of real-world data (RWD) in the context of regulatory decision-making and Health Technology Assessment (HTA). The advisory board and the clinical expert work meetings are important components of the project in a reflective and impulse-giving capacity. Close work with patient organisations will guarantee that the patients’ perspectives and expectations are considered. The overall structure and interrelation of the WPs and project members are depicted below.
WP1 – Use cases in Pre-Authorisation & Evaluation
Leader: DKMA (DAC)
Objectives: The overall objective of this WP is the preparation of good practice examples for the use of RWD in the pre-authorisation and evaluation stages of the product life cycle. This includes the contribution of real-world evidence (RWE) on the phenotypes of Amyotrophic Lateral Sclerosis and breast cancer. It aims to illustrate examples of how the further development of methods and the application of new methodological approaches to different data sources can significantly help to inform regulatory decision-making in pre-authorisation and evaluation steps, as well as HTA and reimbursement decisions.
WP2 – Use cases in Post-Authorisation
Leader: UEF
Objectives: The overall objective of this WP is the preparation of good practice examples for safety and effectiveness analyses of RWD for the post-authorisation stage and the improvement of methods for risk estimation in observational data. This includes the contribution of RWE on the phenotypes of fluoroquinolones and SGLT2 inhibitors. WP2 will illustrate examples of how the further development of methods and the application of new methodological approaches to different data sources can significantly help to inform regulatory decision-making in post-authorisation steps, as well as HTA and reimbursement decisions.
WP3 – Methodology & Tools
Leader: Fraunhofer
Objectives: The objective of WP3 is to develop and implement data science (in particular artificial intelligence/machine learning) algorithms for the entire project. The developed methods will be integrated into a tool package written in Python and R that can be later on used by statisticians/ data scientists within regulatory agencies and HTA.
WP4 – Contextualisation
Leader: BfArM
Objectives: The overall objective of this WP is the interactive constitution of the project context within a process of communication and interpretation with other stakeholders closely involved in RWD/ RWE activities in the field, including patients, industry, payers, HTA bodies, and healthcare professionals. This contextualisation finally aims at a meaningful and embedded implementation (including guidance and training) of the project’s results to health regulatory and HTA practice. The intention of this WP is the extension of project expertise and engagement with players directly involved in the topic, but with adjacent projects and different view angles.
WP5 – Project Management and Coordination
Leader: BfArM
Objectives: The WP5 will maintain an overview and control of project finances, including the coordination and composition of periodic and final financial reports for the EU. It fosters communication with and between the partners and manages communication with the EU. An important task includes monitoring the progress, milestones, and deliverables of the project.
WP6 – Dissemination, Exploitation and Communication
Leader: Infarmed
Objectives: The main objectives of this work package are the development of a communication strategy and dissemination program aimed at outreaching the results of our project to stakeholders of the EU member states, namely patients, healthcare professionals, regulatory bodies, politicians, policymakers, and health insurers