On 3 May 2024, the European Medicines Agency (EMA) has issued a "Reflection Paper on Use of Real-World Data in Non-Interventional Studies to Generate Real-World Evidence". It explores opportunities to harmonise the use of real-world data (RWD) to generate real-world evidence (RWE) in non-interventional studies. This initiative aims to improve the integration of RWE in regulatory decision-making processes, thereby enhancing the evaluation of the benefits and risks of medicines.
Key objectives of the paper are:
- Methodological principles that are considered critical for the conduct and assessment of non-interventional studying using RWD
- The standardisation of terminology: to establish common definitions and metadata standards for RWD and RWE, promoting consistent understanding and usage across international regulatory bodies.
- Quality and relevance: to enhance the quality of RWE, ensuring it meets high standards to support regulatory decisions effectively.
By aligning regulatory expectations and enhancing the integration of RWE into regulatory submissions, this initiative aims to support timely and effective decision-making in the development and approval of innovative treatments, ultimately addressing unmet medical needs and ensuring the safe use of medicines.
The European Medicines Agency (EMA) has opened a public consultation on the reflection paper, inviting stakeholders to provide feedback on the proposed guidelines regarding the utilisation of real-world data in generating evidence outside of clinical trials. The consultation is running until 31 August.
Of note, this consultation was dealt during the “joint HMA/EMA Big Data Steering Group Workshop on Real-World Evidence (RWE) methods” held on 14 June at the EMA premises in Amsterdam. Our head of Research Department, Dr Viviana Giannuzzi, participated in the 3rd session of the workshop dedicated to the EU Roadmap for RWE guidance brining the point of view of the academia. She discussed about its increasing role in the use of RWD for research purposes, especially in fields where the ‘standard’ research methodologies are unfeasible/difficult, like rare diseases and paediatrics, and tools to overcome issues related with data quality and ethics, like those created within EJP RD.
The workshop documentation including the report, presentations and recording of the workshop are available here.