Real-world data (RWD) and real-world evidence (RWE) have the potential to transform how we study the safety, effectiveness, and value of medicines and medical technologies. As researchers, we have opportunities to generate insights from routine clinical care that can complement clinical trials and better reflect how interventions perform in the real world. Despite the incredible potential of RWE -- the growing access to new data sources that reflect people's daily health care experiences and advancements in analytical methods -- the policies for clinical evidence have not kept pace with innovations in research. Through the IDERHA (Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance) public-private initiative, our international, multi-stakeholder team set out to understand and help close this gap. We conducted a landscape review and engaged experts across sectors, with the goal of developing policy recommendations focused on accelerating the pace of policy development. The key findings from our landscape review were that there was a growing recognition of the potential benefits of RWE, there have been significant advancements in RWD and methods, but that the lack of consistent and broadly accepted research practices undermines trust in the quality of research and their findings.

The good news is that our analysis also showed that there are emerging best practices, new procedures and tools as well as examples that could serve as foundations for RWE-specific research practices. These best practices, if more broadly adopted, could serve as models for how RWE studies are conducted, and documented. This standardization would engender trust in the process and the findings. Given the unique nature of RWD, these practices must focus on rigorous approaches to data integrity and governance. Establishing this shared understanding is essential if real-world evidence is to reach its full potential as a trusted component of decision-making.

Ultimately, this is about impact. When decision-makers can confidently rely on real-world evidence, important insights can be translated more quickly into regulatory approvals, coverage decisions, and clinical practice, helping patients gain faster access to safe, effective and valuable innovations. Because ultimately, the value of real-world evidence is not in generating more data but in enabling better decisions, faster access, and better outcomes for patients.

To explore the recommendations and learn more about the work, visit the IDERHA website: https://www.iderha.org/. 

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