Identifying the operational challenges of performing RWE research earlier in the medicine development process and developing practical solutions to increase operational feasibility and better inform its planning and delivery.
The early (possible pre-launch) implementation of research to investigate the effectiveness of medicines in the real world, such as pragmatic trials, can raise many operational challenges. These challenges, which can derive from ethical, regulatory and legal requirements as well as from methodological and quality needs, need to be considered and overcome.
- In the design, set up, and conduct of the research, including the choice of the intervention, comparators and outcomes.
- Regarding the selection of participants – physicians and patients.
- In the monitoring of quality and safety.
WP 3 has two main goals. First, to identify operational challenges when implementing RWE research to investigate the effectiveness of medicines, earlier in the medicine development process. Second, to estimate the impact of these challenges on the ability to generate the RWE originally aimed for and the feasibility of the research and provide practical solutions to help address them.
The key activities of WP3 include:
- Conduct literature reviews and interviews with relevant stakeholders to identify the operational challenges.
- Create a matrix of evidence helping to structure and visualise key challenges for specific design elements.
- Analyse the impact of each challenge in terms of feasibility, generalizability and validity in the context of the study design and develop practical solutions.
- Increased understanding of the operational challenges and better informed decision making regarding the early implementation of RWE research (such as pragmatic trials) to investigate the effectiveness of medicines.
- A decision making support tool which helps study teams identify the main operational challenges they may face when setting up early RWE research and provides potential, practical solutions to address and overcome them.