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Practicalities Of Using Real-World Evidence (RWE) In Comparative Effectiveness Research (CER): Learnings From Imi-Getreal

      Objectives

      The IMI-GetReal project aimed to explore incorporation of robust methods for real-world evidence (RWE) collection and synthesis in the medicines development process, both by pharmaceutical companies and healthcare decision makers. The focus was on the potential use of RWE, alone or in combination with randomized controlled trials (RCTs), to demonstrate effectiveness of new interventions. Seven case studies were conducted in multiple disease areas to examine methods for predicting drug effectiveness and the perspectives of different stakeholders on these methods. This study aimed to identify practical obstacles in accessing and using RWE and RCT data for effectiveness research conducted as part of these case studies.

      Methods

      Qualitative content analysis was conducted to identify and characterize key issues relating to accessing and analyzing study data from external sources, both RWE & RCTs.

      Results

      Accessing RWE from registries proved difficult due to multiple reasons, including: complex and non-transparent application procedures, resistance from registry owners to discuss applications and datasets not being research-ready within project timeframes. There were also issues with RWE eventually accessed, including a lack of individual participant data (IPD) and incomplete data. Where access to IPD from RCTs was obtainable, there were restrictions imposed on how it could be used. For example, it could not be used to target analysis on an individual product, but rather explore methodologies for data synthesis in a product-anonymized setting. This condition encouraged additional data sharing by other stakeholders.

      Conclusions

      Despite the collaborative, multi-stakeholder nature of IMI-GetReal and proper disclosures with data owners, access to data proved challenging. Such barriers to data accessibility can delay effectiveness research, restrict opportunities for the development of methods incorporating RWE and diminish the potential use of RWE in decision-making. Where data is intended to be used for this purpose, sufficient attention should be paid to these potential barriers.