On January 27, Real4Reg hosted its’ third Experts Workshop. This engaging event, with an audience of over 200 people, addressed different perspectives regarding the use of real-world data (RWD) in healthcare. This session focused on the views of different stakeholders over the utilisation of RWD analyses for describing populations affected with diseases.
The workshop started with a presentation delivered by the Real4Reg members Vera Ehrenstein (Aarhus University) and Mohamed Aborageh (Fraunhofer SCAI). The speakers made an overview of the project, talked about the barriers to real-world evidence (RWE) utilisation, addressed the challenges and opportunities in implementing Observational Medical Outcomes Partnership (OMOP) common data model and finalised with “Use Case 1 – Description of the Study Population: Breast Cancer and Amyotrophic Lateral Sclerosis (ALS)” results.
This presentation was followed by a multistakeholder roundtable discussion, moderated by the principal investigator of Real4Reg Britta Haenisch (BfArM). The participants were Daniel Morales (European Medicines Agency, EMA), Lucía Ortiz (Plataforma de Organizaciones de Pacientes, POP), Piia Rannanheimo (Finnish Medicines Agency, Fimea) and Ruben van Eijk (University Medical Center Utrecht). The audience showed their interest in Real4Reg findings through a great engagement in the chat, while the roundtable participants addressed very relevant topics, for example:
- How to overcome the barriers in RWE utilisation in pre-authorisation and evaluation phases
- Advantages, disadvantages and implausible findings of OMOP over native data structure
- Impact and usefulness of Real4Reg’s results
Recordings and presentations
Use Case 1 Results and OMOP Implementation
Vera Ehrenstein (Aarhus University) and Mohamed Aborageh (Fraunhofer SCAI)
Key takeaways:
- Keywords: interoperability, harmonisation, scalability, data access, data sources
- RWD analyses are important in all stages of the medicine lifecycle, from pre- to post-authorisation. However, some countries’ registries are currently lacking data with the required quality and detail.
- The most difficult step in RWD analyses is access to patient’s data. One way to solve this problem might be through the creation of a common registry accessibly to the community, allowing everyone to contribute.
- OMOP has interoperability and scalability as major advantages, but can be very time consuming.
- Real4Reg’s results can be helpful to assess the fitness for purpose of data for a specific research question, helping in the identification of data gaps, establishing methods and frameworks for data analysis and transparently showing the process to increase patient’s trust and willingness to collaborate.