Key points:

• As discussed in the HM2 session, innovation across drug development in view of evidence generation is best served by cross-disciplinary methodological collaboration. As part of this session, we heard that real-world evidence (RWE) as part of this innovation, has the potential to transform drug development, safety and effectiveness. However, there is still a lot of work to be done before it can become the ‘gold standard’ of clinical development, given the need for its reliability and consistency to become fully established
• Initiatives like the data analysis and real world interrogation network (DARWIN EU) have made significant strides in creating institutional approaches to health data collection, fostering collaboration among stakeholders and promoting transparency

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